ARROW recallZ-2368-2026 · Arrow International, LLC · initiated Apr 21, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Arrow International, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On 4/21/2026, correction notices (Firm Event Number: EIF-000608, lidocaine and bupivacaine) were mailed to customers who were asked to do the following: Arrow International LLC is voluntarily recalling product due to the Huons Co. Ltd. recall of Lidocaine and Bupivacaine, which is included in impacted Arrow Kits & Sets. Medical facilities 1. Provide this correction notice to all persons who need to be aware within your organization or to any organization where the potentially affected product has been transferred. 2. Check your inventory for product within the scope of this Medical Device Notification and place a copy of this notice with all affected product. 3. Complete and return the response form virtually via: https://fca.myteleflex.com/en/recall/000608 Distributors: 1. Provide Medical Device Notification to all customers who have received impacted product. Each of your customers is then required to complete the Acknowledgement Form and return it to you as their distributor. 2. Check your inventory for affected product. Place a copy of this notification with all affected product and ensure that the notification is included with future distributions of affected product. 3. Complete and return the response form via link: https://fca.myteleflex.com/en/recall/000608 4. If you have further distributed product outside of your country, please notify Teleflex Customer Service by return email. If you have questions contact firm's Customer Service: Link: https://fca.myteleflex.com/en/recall/000608, Customer Service: Telephone: 1-866-396-2111, FAX: 1-855-419-8507 Email: [email protected] On 5/29/2026, additional amended notices (Firm Event Number: EIF-000608-01) were mailed to include additional affected devices. On 5/1/2026, additional notices (Firm Event Number: EIF-000609, sodium chloride) were mailed and emailed to customers who have 0.9% sodium chloride (10mL saline solution ampule) in kits and sets.
Recall details
- Recall number
- Z-2368-2026
- Status
- Open, Classified
- Initiated by the company
- Apr 21, 2026
- Posted by the FDA
- Jun 13, 2026
- Recalling firm
- Arrow International, LLC
- Quantity
- 785,999
- Product code
- OFB
- Distribution
- US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.
Product description
Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA X 1 1/2IN/NA-04220-S1A; ARTERIAL LINE KIT/AK-04510-S; ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HUMC; ARTERIAL LINE KIT: 18 GA X 6 IN (16 CM)/ASK-04018-OH1; RA CATH KIT: 20 GA X 1 3/4IN (4.45 CM)/ASK-04020-BID; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-MAR; ARTERIAL LINE KIT: 20 GA X 5 IN/ASK-04020-PM4; RA CATH KIT: 20 GA X 1 1/2IN (3.81 CM)/ASK-04120-HF3; RA CATH SET: 20 GA X 2 1/2 IN (6.35 CM)/ASK-04120-UR; ARTERIAL CATH KIT: 20 GA X 3 1/16 IN/ASK-04125-MGH; ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04500-HFH4; ARTERIAL LINE KIT: 20GA X 5IN/ASK-04510-BID2; ARTERIAL LINE KIT: 20GA X 5IN (12 CM)/ASK-04510-EHP1; ARTERIAL LINE KIT/ASK-04510-FEM1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-HFH; ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04510-HFH4; ARTERIAL LINE KIT/ASK-04510-SE; ARTERIAL LINE KIT: 20 GA X 5 IN (12CM)/ASK-04510-TGH2; RA CATH KIT: 20 GA X 12 CM/NA-04550-1A; RA CATH KIT: 20 GA X 12 CM/NA-04550-X1A; RA CATH KIT: 18 GA X 1-3/4IN/AK-04018; RA CATH KIT: 20 GA X 1-3/4IN/AK-04020; RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-C; RA CATH KIT: 20 GA X 1-1/2IN/AK-04120; RA CATH KIT: 22 GA X 1-3/8IN/AK-04122; RA CATH KIT: 20 GA X 1-1/2IN/AK-04220; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-AH; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-ATH; RA CATH KIT: 20 GA X 1 3/4IN (4.45CM)/ASK-04020-AU2; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-BHS; ARTERIAL CATHETERIZATION KIT/ASK-04020-BIDB2; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-CCD1; ARTERIAL CATHETERIZATION KIT/ASK-04020-CR; ART LINE KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-EUH2; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FAM1; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FMC; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-KSF2; RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC2; RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC3; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-LM; RA CATH KIT: 20 GA X 1 3/4IN/ASK-04020-MCH1; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MIH1; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-NWMX; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-PHP; RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-RIHM; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-RMC1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-RU; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-SE; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-SHM; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-SRMC1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UCL1; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-UMI; RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-UN; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC1; RA CATH SET: 20 GA X 1-1/2IN (3.81CM)/ASK-04220-PSU; RA CATH KIT: 20 GA X 1-1/2 IN (3.81 CM)/ASK-04220-UCL1; RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-S1A; CVC KIT: 20 GA X 5 IN (12CM)/ASK-04550-JMC1; ARTERIAL ACCESS TRAY/ASK-04001-BW2; ARTERIAL ACCESS TRAY WITH .025 IN SWG/ASK-04001-WUH1; ARTERIAL LINE KIT/ASK-04510-HUM
Code information (models, lots, serial numbers)
Show the full code information (13k characters)
REF(Material)/UDI-DI/Lot(Batch): TJ-04020-1/10801902193275, 30801902202155/33F24J0338, 33F25A0158, 33F25C0753, 33F25E0281, 33F24B0409; NA-04220-S1A/10801902193275/33F25E1052, 33F24G0553; AK-04510-S/10801902192230, 10801902193275, 10801902196719/33F24A0337, 33F24A0338, 33F24A0339, 33F24A0341, 33F24A0342, 33F24A0343, 33F24A1012, 33F24B0107, 33F24B0108, 33F24B0109, 33F24B0110, 33F24B0111, 33F24C0010, 33F24C0011, 33F24D0015, 33F24D0016, 33F24E0046, 33F24E0047, 33F24G0327, 33F24G0570, 33F24G0571, 33F24G0572, 33F24G0573, 33F24G0574, 33F24G0575, 33F24J0493, 33F24J0674, 33F24J0675, 33F24J0676, 33F24J0677, 33F24K0091, 33F24K0309, 33F24K0313, 33F24L0623, 33F24L0627, 33F24L0629, 33F24L0631, 33F24L0754, 33F24L0783, 33F25A0457, 33F25A0613, 33F25A0614, 33F25A0615, 33F25A0616, 33F25C0738, 33F25C0751, 33F25C0794, 33F25C0846, 33F25C0907, 33F25C0955, 33F25C0956, 33F25E0040, 33F25E0288, 33F25E0289, 33F25E0290, 33F25E0910, 33F25E1065, 33F25E1066, 33F25G0079, 33F25G0158, 33F25H0012, 33F25H0193, 33F25H0194, 33F25H0195, 33F25H0196, 33F25J0464, 33F25J0642, 33F25J0789, 33F25J0801, 33F25J0802, 33F25J0803, 33F25J0804, 33F25L0486, 33F25L0488, 33F26B0668, 33F26B0669, 33F26B0671, 33F26B0672, 33F23L0360; ASK-04018-HUMC/10801902193275/33F25B0360, 33F25K0050, 33F25M0680, 33F25E1176; ASK-04018-OH1/10801902117622, 10801902193275, 10801902117622, 10801902117639/33F24F0741, 33F24L0218, 33F24L0865, 33F25B0173, 33F25C0253, 33F25E0667, 33F25F0162, 33F25J0143, 33F26A1440, 33F26B0794, 33F24A0112; ASK-04020-BID/10801902211429, 10801902193275, 10801902211429/33F24D0870, 33F24E0650, 33F24F0646, 33F24L0220, 33F24L0399, 33F25B0175, 33F25D0335, 33F25E0668, 33F25G0248, 33F25L0123, 33F26A0254, 33F26A1441, 33S23J0777, 33F24G0405; ASK-04020-MAR/10801902193275, 10801902159776/33F24J0567, 33F24L0586, 33F25A0519, 33F25E0136, 33F25E0979, 33F25G0675, 33F25J0504, 33F25L0210, 33F26B0742, 33F25K0032; ASK-04020-PM4/10801902138498, 10801902193275, 10801902138498, 30801902158896/33F24E0428, 33F24E0429, 33F24G0424, 33F24K0188, 33F24L0789, 33F25C0142, 33F25C0821, 33F25E0142, 33F25H0085, 33F25J0883, 33F25L0470, 33F26B0659, 33F24F0095; ASK-04120-HF3/10801902200447, 10801902193275, 10801902200447, 10801902117943/33F24D0857, 33F24F0638, 33F24H0168, 33F24K0389, 33F24L0289, 33F25D0336, 33F25F0126, 33F25F0163, 33F25H0616, 33F25J0202, 33F25M0158, 33F25M0362, 33F26A1429, 33F26B0127, 33S24A1516, 33S24C0854, 33F24A0136; ASK-04120-UR/10801902117943, 10801902193275, 10801902117943/33F24A0769, 33F24B0278, 33F24C0175, 33F24D0140, 33F24E0447, 33F24G0287, 33F24K0201, 33F25B0692, 33F25C0962, 33F25E0156, 33F25H0097, 33F25J0889, 33F25L0383, 33F26C0309, 33F24G0441; ASK-04125-MGH/10801902193275, 10801902139976/33F24J0584, 33F25C0985, 33F25D0307, 33F25E0157, 33F25E0990, 33F25H0098, 33F25J0519, 33F25L0421, 33F26A1057, 33F26B0983, 33F24K0203; ASK-04500-HFH4/10801902200461, 10801902193275, 10801902118001/33F24E0651, 33F24F0722, 33F24L0292, 33F25C0437, 33F25D0228, 33F25E0775, 33F25F0109, 33F25F0164, 33F25H0615, 33F25M0345, 33F26A1363, 33F26B0405, 33S24C0436, 33S24L0292, 33F24A0141; ASK-04510-BID2/10801902193275, 10801902211412, 10801902115024/33F24J0171, 33F25A0165, 33F25C0438, 33F25D0229, 33F25E0852, 33F25G0249, 33F25J0204, 33F25M0233, 33F26A1443, 33F26B0410, 33F24F0820; ASK-04510-EHP1/10801902193275, 10801902115024/33F24L0293, 33F25C0192, 33F25D0230, 33F25E0589, 33F25E0853, 33F25H0646, 33F25L0125, 33F26A0255, 33F26A1520, 33F26B0838, 33F24J0303; ASK-04510-FEM1/10801902214796, 10801902193275/33F24A0831, 33F24B0286, 33F24C0185, 33F24E0456, 33F24E0457, 33F24G0448, 33F24J0304, 33F24L0771, 33F25A0539, 33F25E0165, 33F25G0118, 33F25J0523, 33F26A1051, 33F26B0658, 33F24J0591; ASK-04510-HFH/10801902115031, 10801902193275, 10801902200454/33F24G0053, 33F24L0022, 33F24M0108, 33F24M0190, 33F25A0126, 33F25A0356, 33F25A0384, 33F25B0043, 33F25D0200, 33F25H0329, 33F25H0848, 33F25J0613, 33F26A1358, 33F26B0677, 33F24D0865; ASK-04510-HFH4/10801902200454, 10801902193275/33F24F0865, 33F24J0167, 33F24L0965, 33F25A0236, 33F25C0260, 33F25E0776, 33F25G0332, 33F25J0205, 33F25M0276, 33F26A0305, 33F26B0194, 33F24J0306; ASK-04510-SE/10801902193275, 20801902214038, 10801902217018/33F24K0213, 33F24L0592, 33F25B0251, 33F25C0159, 33F25E0171, 33F25J0527, 33F25L0333, 33F26B0664, 33F24A0873; ASK-04510-TGH2/10801902217018, 10801902193275, 10801902118070/33F24B0292, 33F24C0188, 33F24E0463, 33F24G0289, 33F24K0214, 33F24L0633, 33F25A0542, 33F25C0879, 33F25E0172, 33F25G0120, 33F25J0528, 33F25L0354, 33F25M0862, 33F24C0189; NA-04550-1A/30801902117367, 10801902193275, 33F24A1562, 33F24C0709, 33F24D0331, 33F24E0628, 33F24F0946, 33F24K0382, 33F24L0144, 33F24L1015, 33F25C0223, 33F25D0320, 33F25E0512, 33F25E0663, 33F25E0839, 33F25J0187, 33F25K0199, 33F24K0374; NA-04550-X1A/10801902193275, 30801902117374, 10801902119930/33F24K0704, 33F24L0145, 33F24L1138, 33F25C0465, 33F25C0472, 33F25D0633, 33F25G0387, 33F25J0188, 33F25K0200, 33F26C0354, 33F26C0763, 33F24A1326; AK-04018/10801902190915, 10801902193275, 10801902190939/33F24E0696, 33F24L0051, 33F25A0353, 33F25B0078, 33F25D0714, 33F25G0732, 33F25J0593, 33F26B0039, 33F24A1251; AK-04020/10801902190939, 10801902193275, 60801902121549, 10801902121551/33F24C0727, 33F24C1254, 33F24D0439, 33F24E0697, 33F24F0010, 33F24G0049, 33F24G0116, 33F24G0220, 33F24G0645, 33F24G0646, 33F24G0680, 33F24H0064, 33F24J0013, 33F24J0457, 33F24K0033, 33F24M0004,33F24M0052, 33F24M0070, 33F24M0103,33F24M0146,33F25A0084, 33F25A0335, 33F25A0346, 33F25A0362, 33F25A0397, 33F25B0080, 33F25B0307, 33F25B0414, 33F25C0058, 33F25C0097, 33F25C0494, 33F25C0575, 33F25D0027, 33F25D0083, 33F25D0102, 33F25D0296, 33F25D0703, 33F25F0293, 33F25F0398, 33F25G0493, 33F25H0322, 33F25H0842, 33F25J0037, 33F25J0767, 33F25K0276, 33F25L0154, 33F25L0169, 33F25L0218, 33F26A1264, 33F26A1290, 33F26A1313, 33F26B0291, 33F24C0728, 33F24C0729, 33F24E0699, 33F24G0596, 33F24H0057, 33F24J0350, 33F24J0458, 33F24K0615, 33F24M0126, 33F25A0338, 33F25B0039, 33F25B0131, 33F25D0192, 33F25D0281, 33F25E1109, 33F25F0496, 33F25J0764, 33F26B0054, 33F23M0173; AK-04020-C/60801902121549, 10801902193275, 10801902121551/33F24G0050, 33F24G0595, 33F24G0619, 33F24G0681, 33F24H0060, 33F24H0085, 33F24H0244, 33F24J0421, 33F24J0471, 33F24L0074, 33F24L0517, 33F24M0051, 33F24M0102, 33F24M0145,33F25A0354,33F25B0013, 33F25B0079, 33F25B0130, 33F25B0279, 33F25C0096, 33F25C0411, 33F25C0523, 33F25C0595, 33F25D0014, 33F25D0082, 33F25D0169, 33F25E0404, 33F25E1088, 33F25E1164, 33F25F0430, 33F25J1033, 33F25K0343, 33F25L0175, 33F25M0472, 33F26A0212, 33F26A1275, 33F26B0053, 33F26B0290, 33F23M0171; AK-04120/10801902190922, 10801902193275, 20801902121572/33F24A1254, 33F24B0432, 33F24C0731, 33F24D0440, 33F24E0701, 33F24H0444, 33F24J0006, 33F24K0623, 33F24L0035, 33F24M0127, 33F25A0129, 33F25B0057, 33F25B0328, 33F25E1096, 33F25F0405, 33F25F0522, 33F25G0511, 33F25J1067, 33F26C0419, 33F24C0789; AK-04122/20801902121572, 10801902193275, 10801902121582/33F24G0051, 33F24G0148, 33F24G0682, 33F24K0535, 33F24M0071, 33F25A0092, 33F25A0380, 33F25B0005, 33F25D0108, 33F25J0762, 33F25K0003, 33F24A1009; AK-04220/10801902190946, 10801902193275, 10801902121636/33F24C0733, 33F24E0703, 33F24G0117, 33F24G0223, 33F24G0683, 33F24H0246, 33F24H0414, 33F24J0009, 33F24J0447, 33F24M0003, 33F24M0086, 33F25C0085, 33F25D0171, 33F25G0065, 33F25J0059, 33F26C0392, 33F24A1257; ASK-04020-AH/10801902193275, 10801902114898/33F24L0219, 33F24L0398, 33F24L0950, 33F25B0174, 33F25C0436, 33F25D0332, 33F25D0648, 33F25E0848, 33F25H0647, 33F25J0350, 33F26C0572, 33F24G0403; ASK-04020-ATH/10801902193275, 10801902193237, 10801902205916/33F24J0553, 33F24K0167, 33F24L0777, 33F25C0133, 33F25C0982, 33F25E0964, 33F25G0106, 33F25G0670, 33F25H0063, 33F25H0727, 33F25L0242, 33F25L0452, 33F25M0947, 33F26B0583, 33F24D0856; ASK-04020-AU2/10801902205916, 10801902193275, 10801902117660/33F24E0645, 33F24F1044, 33F24K0365, 33F24L1020, 33F25A0230, 33F25C0225, 33F25D0333, 33F25E0523, 33F25E0849, 33F25H0474, 33F25J0199, 33F25L0120, 33F25M0208, 33F26A1419, 33F26B0449, 33F26C0030, 33F24A0814; ASK-04020-BHS/10801902193275, 30801902144578, 10801902211429/33F25A0231, 33F25D0589, 33F25E0850, 33F25F0095, 33F25G0320, 33F25J0200, 33F26A1514, 33R24D0228, 33S24C0678, 33S24C1077, 33F24D0277; ASK-04020-BIDB2/10801902193275/33F24K0168, 33F25A0508, 33F25C0134, 33F25C0835, 33F25E0121, 33F25G0107, 33F25H0065, 33F25H0728, 33F25J0669, 33F25K0399, 33F25L0429, 33F25M0929, 33F24J0365; ASK-04020-CCD1/10801902193275/33F24J0289, 33F24J0556, 33F24L0641, 33F25A0510, 33F25C0772, 33F25E0123, 33F25G0108, 33F25H0730, 33F25M0874, 33F24G0282; ASK-04020-CR/10801902193275, 10801902206814/33F24K0169, 33F24L0679, 33F25A0511, 33F25C0785, 33F25E0124, 33F25E0969, 33F25G0109, 33F25G0669, 33F25H0067, 33F25H0731, 33F25J0868, 33F25L0241, 33F25M0881, 33F26B0523, 33F24G0407; ASK-04020-EUH2/10801902193275, 10801902213379, 10801902193244/33F24J0290, 33F24J0557, 33F24L0753, 33F25A0512, 33F25C0930, 33F25E0125, 33F25H0068, 33F25J0869, 33F25M0894, 33F26B0236, 33F23H0888; ASK-04020-FAM1/10801902193275/ 33F24H0374, 33F24J0181, 33F24L0734, 33F25C0135, 33F25C0781, 33F25E0126, 33F25E0970, 33F25J0502, 33F24G0408; ASK-04020-FMC/10801902193275, 10801902121384/33F24J0558, 33F24K0171, 33F25A0513, 33F25C0773, 33F25E0127, 33F25E0971, 33F25H0069, 33F25J0870, 33F25L0388, 33F25M0892, 33F24A0828; ASK-04020-KSF2/10801902193275/33F25A0516, 33F25C0851, 33F25E0132, 33F25H0075, 33F25J0876, 33F25M0906, 33F24K0178; ASK-04020-LHC2/10801902193275, 10801902225525/33F24L0716, 33F25A0517, 33F25C0734, 33F25E0133, 33F25J0503, 33F25L0491, 33F25M0922, 33F26C0672; ASK-04020-LHC3/10801902193275, 10801902225525/33F24L0716, 33F25A0517, 33F25C0734, 33F25E0133, 33F25J0503, 33F25L0491, 33F25M0922, 33F26C0672, 33F24L0653; ASK-04020-LM/10801902193275/33F25B0690, 33F25E0977, 33F25H0076, 33F25J0877, 33F25L0422, 33F25M0925, 33F24G0417; ASK-04020-MCH1/10801902193275, 20801902117711/33F24L0920, 33F24A0380; ASK-04020-MIH1/10801902193275/33F24L0744, 33F25A0522, 33F25C0978, 33F25E0138, 33F25H0080, 33F25J0879, 33F26A0996, 33F25A0442; ASK-04020-NWMX/10801902193275/33F24K0186, 33F25J0882, 33F25L0363, 33F25M0872, 33F24G0423; ASK-04020-PHP/10801902193275, 10801902138498/33F24K0187, 33F25A0148, 33F25C0401, 33F25D0283, 33F25E1145, 33F25J1027, 33F24C0164; ASK-04020-RIHM/10801902193275/33F24L0243, 33F24L1034, 33F25B0177, 33F25C0256, 33F25D0462, 33F25E0525, 33F25E0773, 33F25G0317, 33F25H0645, 33F25J0351, 33F26A1408, 33F24M0095; ASK-04020-RMC1/10801902193275/33F25J0509, 33F25L0464, 33F24L0747; ASK-04020-RU/10801902193275/33F25A0524, 33F25C0807, 33F25E0143, 33F25G0112, 33F25J0510, 33F25M0863, 33F24G0427; ASK-04020-SE/10801902193275, 10801902213263, 10801902138757/33F24L0611, 33F25A0525, 33F25C0849, 33F25E0144, 33F25E0984, 33F25J0511, 33F26B0999, 33F24E0433; ASK-04020-SHM/10801902193275/33F24G0428, 33F24J0576, 33F24K0190, 33F24L0684, 33F25A0526, 33F25C0971, 33F25E0145, 33F25G0113, 33F25J0512, 33F25L0378, 33F25M0883, 33F25C0143; ASK-04020-SRMC1/10801902193275, 10801902117837/33F24J0296, 33F24K0192, 33F24L0710, 33F25C0144, 33F25C0820, 33F25E0146, 33F25H0086, 33F25J0884, 33F25M0842, 33F24A0868; ASK-04020-UCL1/10801902193275, 10801902144550/33F24K0412, 33F24L1081, 33F25A0233, 33F25C0257, 33F25D0393, 33F25E0774, 33F25G0360, 33F25J0201, 33F26B0160, 33F24G0178; ASK-04020-UMI/10801902193275, 10801902145571/33F24L1123, 33F24E0726; ASK-04020-UN/10801902145571, 10801902193275, 60801902117849/33F24K0021, 33F24L0533, 33F24M0053, 33F24M0107, 33F25A0089, 33F25B0016, 33F25B0092, 33F25B0314, 33F25D0015, 33F25D0113, 33F25D0172, 33F25E1146, 33F25H0797, 33F25K0230, 33F26B0090, 33F26B0262, 33F24A0373; ASK-04020-UNC/60801902117849, 10801902193275, 10801902143782/33F24A1035, 33F24B0270, 33F24C0170, 33F24G0432, 33F24J0297, 33F24J0577, 33F24L0799, 33F25A0527, 33F25C0145, 33F25C0994, 33F25E0147, 33F25H0088, 33F25J0513, 33F25L0359, 33F25M0868, 33F26A0993, 33F26B0975, 33F24F0461; ASK-04020-UNC1/10801902193275, 10801902143782, 10801902117851/33F24G0286, 33F24J0298, 33F24K0194, 33F24L0806, 33F25C0146, 33F25E0148, 33F25H0089, 33F25J0514, 33F25L0469, 33F25M0959, 33F26C0599, 33F24A0255; ASK-04220-PSU/10801902193275/33F25A0152, 33F25H0737, 33F24K0495; ASK-04220-UCL1/10801902193275, 10801902159127, 10801902143805/33F24L0290, 33F25A0206, 33F25C0226, 33F25D0463, 33F25E0669, 33F25G0351, 33F25H0428, 33F25J0352, 33F26B0153, 33F24F0619; NA-04020-S1A/10801902193275, 10801902139396/33F25A0600, 33F25C0195, 33F25C0786, 33F25E0270, 33F25E1050, 33F25G0152, 33F25H0177, 33F25H0759, 33F25J0633, 33F25K0404, 33F25L0472, 33F25M0962, 33F26B0595, 33F24J0683; ASK-04550-JMC1/10801902193275, 10801902130836/33F25C0837, 33F25E0175, 33F25E0997, 33F25L0146, 33F24F0685; ASK-04001-BW2/10801902193275, 10801902221602/33F25A0500, 33F25E0110, 33F25H0057, 33F25J0496, 33F25L0360, 33F26A0994, 33S23M0157, 33F25A0226; ASK-04001-WUH1/10801902193275, 10801902220834, 10801902119268/33F24J0549, 33F24K0162, 33F24L0685, 33F25H0061, 33F25J0864, 33F26B0683, 33F26B1021, 33F24A0078; ASK-04510-HUM/10801902115048/33F24C0956, 33F24D0699, 33F24E0647, 33F24F0911, 33F24L0885
Devices named in this recall
57 devices in the FDA device registry whose identifier appears in the recall's code information.
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
- ARROW IPN037007Teleflex Incorporated · WIRE, GUIDE, CATHETER3 recalls2 reports
- ARROW IPN036829Teleflex Incorporated · Wire, guide, catheter3 recalls1 report
- ARROW IPN037106Teleflex Incorporated · Syringe, piston2 recalls4 reports
- ARROW IPN037078Teleflex Incorporated · CATHETER, PERCUTANEOUS2 recalls3 reports
- ARROW IPN037023Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls0 reports
- ARROW IPN037000Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls0 reports
- ARROW IPN037005Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls0 reports
- ARROW IPN036981Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls0 reports
- ARROW IPN037006Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls0 reports
- ARROW IPN037163Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls0 reports
- ARROW IPN037025Teleflex Incorporated · INTRODUCER, CATHETER2 recalls0 reports
- ARROW IPN037207Teleflex Incorporated · WIRE, GUIDE, CATHETER2 recalls0 reports
- ARROW IPN037084Teleflex Incorporated · Syringe, piston2 recalls0 reports
- ARROW IPN037724Teleflex Incorporated2 recalls0 reports
- ARROW IPN029646Teleflex Incorporated · Catheter, percutaneous2 recalls0 reports
- ARROW IPN919755Teleflex Incorporated · Wire, guide, catheter2 recalls0 reports
- ARROW IPN919758Teleflex Incorporated · Wire, guide, catheter2 recalls0 reports
- ARROW IPN921748Teleflex Incorporated · Wire, guide, catheter2 recalls0 reports
- ARROW IPN925200Teleflex Incorporated · Wire, guide, catheter2 recalls0 reports
- ARROW IPN927215Teleflex Incorporated · Wire, guide, catheter2 recalls0 reports
- ARROW IPN029798Teleflex Incorporated · Wire, guide, catheter2 recalls0 reports
- ARROW IPN055749Teleflex Incorporated · Wire, guide, catheter2 recalls0 reports
- ARROW IPN922619Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC2 recalls0 reports
- ARROW IPN037160Teleflex Incorporated · Wire, guide, catheter1 recall7 reports
- ARROW IPN921746Teleflex Incorporated · Wire, guide, catheter1 recall6 reports
- ARROW IPN036514Teleflex Incorporated · Wire, guide, catheter1 recall5 reports
- ARROW IPN921747Teleflex Incorporated · Wire, guide, catheter1 recall4 reports
- ARROW IPN036478Teleflex Incorporated · Wire, guide, catheter1 recall3 reports
- ARROW IPN036497Teleflex Incorporated · WIRE, GUIDE, CATHETER1 recall2 reports
- ARROW IPN029791Teleflex Incorporated · Wire, guide, catheter1 recall2 reports
- ARROW IPN914903Teleflex Incorporated · Wire, guide, catheter1 recall2 reports
- ARROW IPN037070Teleflex Incorporated · Wire, guide, catheter1 recall2 reports
- ARROW IPN036532Teleflex Incorporated · WIRE, GUIDE, CATHETER1 recall1 report
- ARROW IPN038368Teleflex Incorporated · Wire, guide, catheter1 recall1 report
- ARROW IPN927640Teleflex Incorporated · Wire, guide, catheter1 recall1 report
- ARROW IPN036480Teleflex Incorporated · WIRE, GUIDE, CATHETER1 recall0 reports
- ARROW IPN036533Teleflex Incorporated · WIRE, GUIDE, CATHETER1 recall0 reports
- ARROW IPN036907Teleflex Incorporated · WIRE, GUIDE, CATHETER1 recall0 reports
- ARROW IPN037051Teleflex Incorporated · WIRE, GUIDE, CATHETER1 recall0 reports
- ARROW IPN038269Teleflex Incorporated · Wire, guide, catheter1 recall0 reports
- ARROW IPN038297Teleflex Incorporated · Wire, guide, catheter1 recall0 reports
- ARROW IPN038406Teleflex Incorporated · Wire, guide, catheter1 recall0 reports
- ARROW IPN029644Teleflex Incorporated · Wire, guide, catheter1 recall0 reports
- ARROW IPN039772Teleflex Incorporated · Wire, guide, catheter1 recall0 reports
- ARROW IPN919756Teleflex Incorporated · Wire, guide, catheter1 recall0 reports
- ARROW IPN919757Teleflex Incorporated · Wire, guide, catheter1 recall0 reports
- ARROW IPN923183Teleflex Incorporated · Wire, guide, catheter1 recall0 reports
- ARROW IPN923856Teleflex Incorporated · Wire, guide, catheter1 recall0 reports
- ARROW IPN925199Teleflex Incorporated · Wire, guide, catheter1 recall0 reports
- ARROW IPN927206Teleflex Incorporated · Wire, guide, catheter1 recall0 reports
- ARROW IPN928684Teleflex Incorporated · Wire, guide, catheter1 recall0 reports
- TELEFLEX IPN929735Teleflex Incorporated · Wire, guide, catheter1 recall0 reports
- ARROW IPN930503Teleflex Incorporated · Wire, guide, catheter1 recall0 reports
- ARROW IPNB00025Teleflex Incorporated · Wire, guide, catheter1 recall0 reports
- ARROW IPN927207Teleflex Incorporated · Wire, guide, catheter1 recall0 reports
- ARROW IPN036980Teleflex Incorporated · Wire, guide, catheter1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 98793).
- Z-2363-2026 · Open, ClassifiedPARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU
- Z-2364-2026 · Open, ClassifiedDescription/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS;…
- Z-2365-2026 · Open, ClassifiedDescription/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU
- Z-2366-2026 · Open, ClassifiedDescription/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM
- Z-2367-2026 · Open, ClassifiedDescription/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-45563-VPSC; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHD1; ARROW(R) V…
- Z-2369-2026 · Open, ClassifiedDescription/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU4; PSI/CVC KIT: 9 FR/7 FR X 6IN (16CM)/ASK-09903-AMC1; PSI KIT: 9 …
- Z-2370-2026 · Open, ClassifiedDescription/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2L 5.5 FR X 50 CM/ASK-45052-NS AGBA PICC/DELTA KIT: 1L 4.5 FR X 55 CM/ASK-45541-MHBV PICC KIT…
- Z-2371-2026 · Open, ClassifiedDescription/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501; EPIDURAL CATHETERIZATION KIT/AK-05502; EPIDURAL CATHETERIZATION K…
- Z-2372-2026 · Open, ClassifiedDescription/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A
- Z-2373-2026 · Open, ClassifiedDescription/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122; HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB/AK-22142-CDC; HEMODIALYS…
- Z-2374-2026 · Open, ClassifiedDescription/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/AK-15123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-1…
- Z-2376-2026 · Open, ClassifiedDescription/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-…
- Z-2377-2026 · Open, ClassifiedDescription/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSE…
- Z-2378-2026 · Open, ClassifiedDescription/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV; AGBA PICC: 1L 4.5FR …
- Z-2379-2026 · Open, ClassifiedDescription/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGBA PI JACC KIT: 1-L 4.5 FR X 15 CM/CDC-41541-JX1A; AGBA PI JA…
- Z-2380-2026 · Open, ClassifiedDescription/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000
- Z-2381-2026 · Open, ClassifiedDescription/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F
- Z-2382-2026 · Open, ClassifiedDescription/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM, THORACENTESIS KIT/AK-01000-T, THORACENTESIS KIT/AK-01000, THORACENTESIS KIT/ASK-01000-CHP,…
- Z-2383-2026 · Open, ClassifiedDescription/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU
- Z-2384-2026 · Open, ClassifiedDescription/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-12703-PSPH1; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-WMC2; MULTILUME…
- Z-2385-2026 · Open, ClassifiedDescription/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1; PSI KIT: 9 FR X 10 CM/ASK-09903-KH;…
- Z-2387-2026 · Open, ClassifiedDescription/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC
- Z-2388-2026 · Open, ClassifiedDescription/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3L 12 FR X 16 CM/ASK-12123-UOC1, AHDC KIT: 3-L 12 FR X 16 CM/ASK-12123-UPM, AHDC KIT: 3L 12 FR X 20 C…
- Z-2389-2026 · Open, ClassifiedDescription/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; SPINAL ANESTHESIA KIT/ASA-25090-SB; SPINAL ANESTHESIA KIT: 24 GA X 9 CM/ASK-24090-SA; SPINA…
- Z-2390-2026 · Open, ClassifiedDescription/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM W CHG/SAC-01218-C; SAC KIT: 18 GA X 16CM W BIO/SAC-01618-B
- Z-2391-2026 · Open, ClassifiedDescription/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW; ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM5; CATH SL 20 GA X 5 CM HYDROPHIL…
- Z-2393-2026 · Open, ClassifiedDescription/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU5; PSI KIT: 8.5 FR/ASK-09807-UC; PSI KIT: 9 FR X 4 1/8IN (10 CM)/ASK-09903-HH2; …
- Z-2394-2026 · Open, ClassifiedDescription/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MIDLINE 1L: 4.5FR X 15CM/CDC-41541-MPK1A; AM/AT PI MIDLINE 2L: 5.5FR X 15CM/CDC-41552-MPK1A; AGBA PI MI…
- Z-2396-2026 · Open, ClassifiedDescription/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT: 14 GA X 6 IN/CK-04711
- Z-2397-2026 · Open, ClassifiedDescription/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA; ARTERIAL CATHETER KIT: 18 …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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