Sterile Procedural Trays, labeled as the following recallZ-1097-2023 · MEDLINE INDUSTRIES, LP - Northfield · initiated Nov 17, 2022
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 MEDLINE INDUSTRIES, LP - Northfield 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
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
FDA root cause category: Device Design
What the company is doing
Medline Industries, LP notified consignees via email and first-class mail on 11/15/2022. Consignees were instructed to check stock for affected product and immediately quarantine. For any affected units, customers were instructed to over-label the sterile kits with a warning label indicating "Warning To Avoid Injury, Please Handle Blades with Care." No product is to be returned. Customers were also instructed to complete and return the response form and notify customers if further distributed.
Recall details
- Recall number
- Z-1097-2023
- Status
- Open, Classified
- Initiated by the company
- Nov 17, 2022
- Posted by the FDA
- Feb 6, 2023
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 1,419 cases (4,349 units)
- Product code
- OII
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Product description
Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY CDS c. ARTHROSCOPY LV - EDOC PACK-LF d. ARTHROSCOPY PACK-LF e. ARTHROSCOPY PACK f. ARTHRO PACK-LF g. ARTHROSCOPY PACK-LF h. ARTHROSCOPY PACK-LF i. ARTHROSCOPY KNEE TRAY-LF j. ARTHROSCOPY PACK-LF k. ARTHROSCOPY BASIN PACK-LF l. ARTHROTOMY PACK-LF m. ARTHROSCOPY PACK-LF n. ARTHROSCOPY PACK o. ARTHROSCOPY PACK p. ARTHROSCOPY PACK q. ARTHROSCOPY PACK - LF r. SC ARTHROSCOPY PACK s. ARTHROSCOPY PACK-LF t. ARTHROSCOPY PACK u. ARTHROSCOPY PACK v. ARTHROSCOPY PACK w. OSC ARTHROSCOPY PK-LF x. ARTHROSCOPY PACK y. ARTHROSCOPY PACK z. ARTHROSCOPY PACK aa. ARTHROSCOPY PACK bb. ARTHROSCOPY PACK cc. KNEE ARTHROSCOPY PACK dd. KNEE ARTHROSCOPY PACK ee. SHOULDER ARTHROSCOPY PACK ff. SHOULDER ARTHROSCOPY gg. ARTHROSCOPY PACK hh. ARTHROSCOPY PACK ii. ARTHROSCOPY PACK jj. ARTHROSCOPY PACK kk. ARTHROSCOPY PACK ll. ARTHROSCOPY PACK-LF mm. ARTHROSCOPY KNEE nn. ARTHROSCOPY PACK oo. HIP ARTHROSCOPY PACK pp. ARTHROSCOPY PACK qq. MG NS KNEE ARTHROSCOPY PACK rr. KNEE ARTHROSCOPY PACK ss. ARTHROSCOPY PACK tt. ARTHROSCOPY-LF uu. ARTHROSCOPY KIT vv. SHOULDER ARTHROSCOPY ww. KNEE ARTHROSCOPY xx. ARTHROSCOPY PACK
Code information (models, lots, serial numbers)
Show the full code information (7k characters)
a. KNEE ARTHROSCOPY CDS-LF, Item Number: CDS940869U, Case UDI/GTIN: 40195327210046, Unit UDI/GTIN: 10195327210045, Lot Number: 22JBR468,22JBA443; b. ARTHROSCOPY CDS, Item Number: CDS985208B, Case UDI/GTIN: 40889942942061, Unit UDI/GTIN: 10889942942060, Lot Number: 22JBR379,22IBS410,22IBO331,22IBO332; c. ARTHROSCOPY LV - EDOC PACK-LF, Item Number: DYNJ0111409L, Case UDI/GTIN: 40889942824015, Unit UDI/GTIN: 10889942824014, Lot Number: 22JMH535,22IMF440; d. ARTHROSCOPY PACK-LF, Item Number: DYNJ0376528J, Case UDI/GTIN: 40889942395935, Unit UDI/GTIN: 10889942395934, Lot Number: 22JBJ567; e. ARTHROSCOPY PACK, Item Number: DYNJ04446N, Case UDI/GTIN: 40888277753649, Unit UDI/GTIN: 10888277753648, Lot Number: 22JMH875,22HMG756; f. ARTHRO PACK-LF, Item Number: DYNJ0637509B, Case UDI/GTIN: 40889942079255, Unit UDI/GTIN: 10889942079254, Lot Number: 22IMH393; g. ARTHROSCOPY PACK-LF, Item Number: DYNJ0751097M, Case UDI/GTIN: 40195327196364, Unit UDI/GTIN: 10195327196363, Lot Number: 22HMC138; h. ARTHROSCOPY PACK-LF, Item Number: DYNJ0890114F, Case UDI/GTIN: 40889942824039, Unit UDI/GTIN: 10889942824038, Lot Number: 22JMC992,22IMG334; i. ARTHROSCOPY KNEE TRAY-LF, Item Number: DYNJ09577J, Case UDI/GTIN: 40889942104803, Unit UDI/GTIN: 10889942104802, Lot Number: 22IBJ738; j. ARTHROSCOPY PACK-LF, Item Number: DYNJ15916C, Case UDI/GTIN: 40888277861610, Unit UDI/GTIN: 10888277861619, Lot Number: 22KBA679,22JBS955; k. ARTHROSCOPY BASIN PACK-LF, Item Number: DYNJ16633C, Case UDI/GTIN: 40888277858450, Unit UDI/GTIN: 10888277858459, Lot Number: 22JBV974; l. ARTHROTOMY PACK-LF, Item Number: DYNJ19751B, Case UDI/GTIN: 40884389018423, Unit UDI/GTIN: 10884389018422, Lot Number: 22IME726; m. ARTHROSCOPY PACK-LF, Item Number: DYNJ24861D, Case UDI/GTIN: 40888277545398, Unit UDI/GTIN: 10888277545397, Lot Number: 22JBJ980,22JBG368; n. ARTHROSCOPY PACK, Item Number: DYNJ26870I, Case UDI/GTIN: 40889942605669, Unit UDI/GTIN: 10889942605668, Lot Number: 22IBN707; o. ARTHROSCOPY PACK, Item Number: DYNJ30719C, Case UDI/GTIN: 40888277077745, Unit UDI/GTIN: 10888277077744, Lot Number: 22JBW329; p. ARTHROSCOPY PACK, Item Number: DYNJ31889C, Case UDI/GTIN: 40889942122777, Unit UDI/GTIN: 10889942122776, Lot Number: 22JBF800; q. ARTHROSCOPY PACK - LF, Item Number: DYNJ33193A, Case UDI/GTIN: 40884389363967, Unit UDI/GTIN: 10884389363966, Lot Number: 22IBD173; r. SC ARTHROSCOPY PACK, Item Number: DYNJ34330C, Case UDI/GTIN: 40889942577027, Unit UDI/GTIN: 10889942577026, Lot Number: 22IMD384; s. ARTHROSCOPY PACK-LF, Item Number: DYNJ34797I, Case UDI/GTIN: 40889942451693, Unit UDI/GTIN: 10889942451692, Lot Number: 22IMC421; t. ARTHROSCOPY PACK, Item Number: DYNJ35435C, Case UDI/GTIN: 40888277554697, Unit UDI/GTIN: 10888277554696, Lot Number: 22JBF703; u. ARTHROSCOPY PACK, Item Number: DYNJ35733F, Case UDI/GTIN: 40889942107866, Unit UDI/GTIN: 10889942107865, Lot Number: 22IBN489; v. ARTHROSCOPY PACK, Item Number: DYNJ36624D, Case UDI/GTIN: 40889942540304, Unit UDI/GTIN: 10889942540303, Lot Number: 22JBG374,22IBA906; w. OSC ARTHROSCOPY PK-LF, Item Number: DYNJ37381C, Case UDI/GTIN: 40889942292210, Unit UDI/GTIN: 10889942292219, Lot Number: 22JBY499,22JBB033,22HBY104; x. ARTHROSCOPY PACK, Item Number: DYNJ40334, Case UDI/GTIN: 40884389852737, Unit UDI/GTIN: 10884389852736, Lot Number: 22JBK330; y. ARTHROSCOPY PACK, Item Number: DYNJ42208B, Case UDI/GTIN: 40888277744142, Unit UDI/GTIN: 10888277744141, Lot Number: 22JBP189; z. ARTHROSCOPY PACK, Item Number: DYNJ45173D, Case UDI/GTIN: 40889942485223, Unit UDI/GTIN: 10889942485222, Lot Number: 22JBG783; aa. ARTHROSCOPY PACK, Item Number: DYNJ45340B, Case UDI/GTIN: 40889942120605, Unit UDI/GTIN: 10889942120604, Lot Number: 22IBL202; bb. ARTHROSCOPY PACK, Item Number: DYNJ47103C, Case UDI/GTIN: 40889942489177, Unit UDI/GTIN: 10889942489176, Lot Number: 22JMH577,22IME064; cc. KNEE ARTHROSCOPY PACK, Item Number: DYNJ48572, Case UDI/GTIN: 40888277913890, Unit UDI/GTIN: 10888277913899, Lot Number: 22JBH940; dd. KNEE ARTHROSCOPY PACK, Item Number: DYNJ50120D, Case UDI/GTIN: 40195327195657, Unit UDI/GTIN: 10195327195656, Lot Number: 22JBG571; ee. SHOULDER ARTHROSCOPY PACK, Item Number: DYNJ50126D, Case UDI/GTIN: 40195327212170, Unit UDI/GTIN: 10195327212179, Lot Number: 22JBG572,22IBD245; ff. SHOULDER ARTHROSCOPY, Item Number: DYNJ51381, Case UDI/GTIN: 40889942161325, Unit UDI/GTIN: 10889942161324, Lot Number: 22JBG797; gg. ARTHROSCOPY PACK, Item Number: DYNJ52778A, Case UDI/GTIN: 40889942638117, Unit UDI/GTIN: 10889942638116, Lot Number: 22HMC946; hh. ARTHROSCOPY PACK, Item Number: DYNJ52813, Case UDI/GTIN: 40889942328926, Unit UDI/GTIN: 10889942328925, Lot Number: 22JBD518; ii. ARTHROSCOPY PACK, Item Number: DYNJ56088A, Case UDI/GTIN: 40888277762900, Unit UDI/GTIN: 10888277762909, Lot Number: 22JBW279,22HBR114; jj. ARTHROSCOPY PACK, Item Number: DYNJ57151, Case UDI/GTIN: 40889942721901, Unit UDI/GTIN: 10889942721900, Lot Number: 22JBI446; kk. ARTHROSCOPY PACK, Item Number: DYNJ57741, Case UDI/GTIN: 40889942773672, Unit UDI/GTIN: 10889942773671, Lot Number: 22JBD988; ll. ARTHROSCOPY PACK-LF, Item Number: DYNJ58470, Case UDI/GTIN: 40889942856030, Unit UDI/GTIN: 10889942856039, Lot Number: 22JBT149,22IBU283; mm. ARTHROSCOPY KNEE, Item Number: DYNJ68081B, Case UDI/GTIN: 40195327199853, Unit UDI/GTIN: 10195327199852, Lot Number: 22IBN483; nn. ARTHROSCOPY PACK, Item Number: DYNJ82486, Case UDI/GTIN: 40195327197422, Unit UDI/GTIN: 10195327197421, Lot Number: 22HBT060; oo. HIP ARTHROSCOPY PACK, Item Number: DYNJ82503, Case UDI/GTIN: 40195327197378, Unit UDI/GTIN: 10195327197377, Lot Number: 22HBL505; pp. ARTHROSCOPY PACK, Item Number: DYNJ82546, Case UDI/GTIN: 40195327197927, Unit UDI/GTIN: 10195327197926, Lot Number: 22HBV066; qq. MG NS KNEE ARTHROSCOPY PACK, Item Number: DYNJ82585, Case UDI/GTIN: 40195327198764, Unit UDI/GTIN: 10195327198763, Lot Number: 22IBE887; rr. KNEE ARTHROSCOPY PACK, Item Number: DYNJ82630, Case UDI/GTIN: 40195327199525, Unit UDI/GTIN: 10195327199524, Lot Number: 22JBE442; ss. ARTHROSCOPY PACK, Item Number: DYNJ82707, Case UDI/GTIN: 40195327202317, Unit UDI/GTIN: 10195327202316, Lot Number: 22JMH335,22JMF855; tt. ARTHROSCOPY-LF, Item Number: DYNJ903247B, Case UDI/GTIN: 40889942754664, Unit UDI/GTIN: 10889942754663, Lot Number: 22JBQ059; uu. ARTHROSCOPY KIT, Item Number: DYNJ904304G, Case UDI/GTIN: 40195327209316, Unit UDI/GTIN: 10195327209315, Lot Number: 22JBR652,22IBT829; vv. SHOULDER ARTHROSCOPY, Item Number: DYNJ908907, Case UDI/GTIN: 40195327215577, Unit UDI/GTIN: 10195327215576, Lot Number: 22JBJ375; ww. KNEE ARTHROSCOPY, Item Number: DYNJ908920, Case UDI/GTIN: 40195327215874, Unit UDI/GTIN: 10195327215873, Lot Number: 22JBA830; xx. ARTHROSCOPY PACK, Item Number: DYNJHS0101I, Case UDI/GTIN: 40888277046413, Unit UDI/GTIN: 10888277046412, Lot Number: 22IBK139
Devices named in this recall
50 devices in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYNJ50120DMedline Industries, Inc. · Arthrogram tray2 recalls0 reports
- Medline Industries, Inc. DYNJHS0101IMedline Industries, Inc. · Arthrogram tray2 recalls0 reports
- Medline Industries, Inc. DYNJ45173DMedline Industries, Inc. · Arthrogram tray2 recalls0 reports
- Medline Industries, Inc. DYNJ0751097MMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ82503Medline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ82486Medline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ82546Medline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ82585Medline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ82630Medline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ68081BMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ82707Medline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ904304GMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. CDS940869UMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ50126DMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ908907Medline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ908920Medline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ19751BMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ33193AMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ40334Medline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ30719CMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ24861DMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ35435CMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ42208BMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ04446NMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ56088AMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ16633CMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ15916CMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ48572Medline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ0637509BMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ09577JMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ35733FMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ45340BMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ31889CMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ51381Medline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ37381CMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ52813Medline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ0376528JMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ34797IMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ47103CMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ36624DMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ34330CMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ26870IMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ52778AMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ57151Medline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ903247BMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ57741Medline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ0111409LMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ0890114FMedline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. DYNJ58470Medline Industries, Inc. · Arthrogram tray1 recall0 reports
- Medline Industries, Inc. CDS985208BMedline Industries, Inc. · Arthrogram tray1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 91386).
- Z-1060-2023 · Open, ClassifiedANCILLARY PACK-LF. Sterile Procedural Tray.
- Z-1061-2023 · Open, ClassifiedTRACH PACK. Sterile Procedural Tray.
- Z-1062-2023 · Open, ClassifiedLOCAL PACK. Sterile Procedural Tray.
- Z-1063-2023 · Open, ClassifiedSterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASIC
- Z-1064-2023 · Open, ClassifiedUNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
- Z-1065-2023 · Open, ClassifiedFEMORAL ARTERY PACK-LF. Sterile Procedural Tray
- Z-1066-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BASIC SET UP PACK; d. IMPLANT PACK-LF; e. PORT PACEMAKER INSERTI…
- Z-1067-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALV…
- Z-1068-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DERM SURG PACK c. THROMBECTOMY PACK-LF d. AV FISTULA PACK e. AV SHUNT PACK-LF f. RR-V…
- Z-1069-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRHOID PACK g. RECT…
- Z-1070-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL
- Z-1071-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c. RHYZOTOMY
- Z-1072-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH PARA/THYROIDECTOMY CDS g. CAM …
- Z-1073-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF
- Z-1074-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS d. LAPAROSCOPY CDS-LF e. GENERAL LAPAROSCOPY PROCEDURE f. L…
- Z-1075-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY
- Z-1076-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO
- Z-1077-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. ACH PLASTICS BREAST-LF e. NE BREAST RECON CDS f. P…
- Z-1078-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE BASIN SET d. LAPAROTOMY BASIN e. ORTHOPEDIC CUSTOM BASIN SET f.…
- Z-1079-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECO…
- Z-1080-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK
- Z-1081-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK
- Z-1082-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: IM NAIL
- Z-1083-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN
- Z-1085-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: LS MS PACK
- Z-1086-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK
- Z-1088-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT CDS c. NEURO CDS-LF d. MAJOR NEURO e. NEURO PACK-LF f. CUSTOM NEURO PACK-LF g. NEURO PACK-L…
- Z-1089-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR VAGINAL-LF f. GYN …
- Z-1090-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY
- Z-1091-2023 · Open, ClassifiedSterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e. GYN LAPAROSCOPY CDS f. UNIVERSAL ROBO…
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.
How recalls are matched to devices · Editorial policy · Report an error on this page