Medline Probe Cover Kits containing sterile Ultrasound Gel… recallZ-2176-2023 · MEDLINE INDUSTRIES, LP - Northfield · initiated May 18, 2023
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
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
FDA root cause category: Device Design
What the company is doing
Medline distributed their recall notices to their consignees beginning on 05/18/2023 by letter. The notices explained the problem, and the risk and requested the destruction of the products. Distributors were directed to notify their consignees, have the customers document and destroy any affected product, and include your customers quantities on the response form. Beginning on 05/23/2023, Medline issued another notice to a separate group of consignees requesting that the kits be over labeled. Distributors were directed to notify the customers and have them return any affected product to the distributor for collection and return to Medline. Questions: please contact the Recall Department at 866-359-1704
Recall details
- Recall number
- Z-2176-2023
- Status
- Open, Classified
- Initiated by the company
- May 18, 2023
- Posted by the FDA
- Jul 20, 2023
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 4644 units
- Product code
- PPB
- Distribution
- Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Product description
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F; b) ENDOVENOUS CORE PACK, Model Number DYNJ62557; c) ENSEMBLE CATHETER DIALYSE-LF, Model Number DYNJ81973; d) TVS4000 ENDOVENOUS PACK, Model Number TVS4000K
Code information (models, lots, serial numbers)
all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJ46967F, UDI/DI (EA) 10193489576047UDI/DI (CS) 40193489576048; b) Model Number DYNJ62557, UDI/DI (EA) 10193489669152UDI/DI (CS) 40193489669153; c) Model Number DYNJ81973, UDI/DI (EA) 10195327204877UDI/DI (CS) 40195327204878; d) Model Number TVS4000K, UDI/DI (EA) 10816982023862UDI/DI (CS) 40816982023863;
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYNJ46967FMedline Industries, Inc. · Foley catheter kit (excludes HIV testing)1 recall0 reports
- Medline Industries, Inc. DYNJ62557Medline Industries, Inc. · Foley catheter kit (excludes HIV testing)1 recall0 reports
- Medline Industries, Inc. DYNJ81973Medline Industries, Inc. · Foley catheter kit (excludes HIV testing)1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 92466).
- Z-2154-2023 · Open, ClassifiedMedline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use during diagnostic ultrasound procedures
- Z-2155-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ANESTHESIA OH TOTE, Model Number DYNJ61476
- Z-2156-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ81722; b) PAIN BLOCK TRAY, Model Number DYNJRA0827A; c) PAI…
- Z-2157-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number DYNJ45158A
- Z-2158-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220; b) PERI NEURO BLOCK PACK-LF, Model N…
- Z-2159-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH, Model Number 00-401318M; b) ANGIOGRAPHY OR, Model Number CD…
- Z-2160-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRAPE PACK, Model Number 00-400305R; b) ANGIO HOLLAND PACK-LF, Model Number D…
- Z-2161-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number DYNJ55252C; b) CATH LAB PACK, Model Number DYNJ55455A; c)…
- Z-2162-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK, Model Number DYNJ83105; b) TESIO, Model Number DYNJ83251; c) ANGIOGRAPHY PACK…
- Z-2163-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q; b. PERCUTANEOUS VASCULAR CDS, Mod…
- Z-2164-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID PK-LF, Model Number DYNJ53433K; b) VEIN SPECIALISTS PACK, Model Numbe…
- Z-2165-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK, Model Number DYNJ67770A; b) EP PROCEDURE PACK, Model Number DYNJ67771; c)…
- Z-2166-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CROSS OPEN HEART, Model Number DYNJ906102G; b) SILVER CROSS OPEN HEART, Model Numb…
- Z-2167-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL BUNDLE NO CATHETER, Model Number ART995; b) ART LINE KIT NO CATH, Model Number A…
- Z-2168-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) PORT PACK, Model Number DYNJ64675; b) PICC LINE TRAY, Model Number DYNJ64725B; c) VEIN O…
- Z-2169-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214Q; b) MINOR PROCEDURE TRAY, Model Number DYND…
- Z-2170-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST BIOPSY KIT, Model Number DYNDA1224B; b) U/S CORE BIOPSY KIT, Model Number DYNDH112…
- Z-2171-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model Number OST011F
- Z-2172-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CHP COCHLEAR SUPPLEMENT CDS, Model Number CDS983069I; b) HEAD AND NECK PACK, Model Number…
- Z-2173-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETOSCOPY CDS-LF, Model Number CDS840215O; b) US BREAST BIOPSY TRAY, Model Number DYNDH…
- Z-2174-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PACK ENDO AAA HYBRID CHRG, Model Number DYNJ60126B
- Z-2175-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETER INSERTION KIT CLABSI, Model Number CVI4880; b) CENTRAL CATHETER INSERTION TRA, …
- Z-2177-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK, Model Number DYNDH1306; b) BRST BX TRAY, Model Number DYNDH1389B; c) PLAST…
- Z-2178-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB BASIN PACK, Model Number DYNJ69864A
- Z-2179-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NO-CATH RADIAL ARTERIAL PREMIU, Model Number ARTNC115; b) MAJOR VASCULAR, Model Number C…
- Z-2180-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT, Model Number DYNJ55841B; b) FACELIFT PACK, Model Number DYNJ55954B; c) CLOT R…
- Z-2181-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755; b) VNUS TEST KIT CFP-LF, Model Number …
- Z-2182-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) UNIVERSAL INSERTION TRAY, Model Number CVI4325; b) PPE BUNDLE KIT, Model Number DT13351A
- Z-2183-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) IV SECUREMENT KIT, Model Number DYNDV2407A; b) USG IV START KIT, Model Number DYNDV2435;…
- Z-2184-2023 · Open, ClassifiedMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Number DYNDL1134A; b) ULTRASOUND GUIDED IV/MIDLINE K, Model Numbe…
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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