Convenience kits recallZ-3209-2026 · Medline Industries, LP · initiated Jul 31, 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 Medline Industries, LP 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
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
FDA root cause category: Under Investigation by firm
What the company is doing
Firm began notifying customers on July 31, 2026 via email and first-class mail. Customers were instructed to discard any affected sterile convenience kits.
Recall details
- Recall number
- Z-3209-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 31, 2026
- Posted by the FDA
- Sep 16, 2026
- Recalling firm
- Medline Industries, LP
- Quantity
- 60
- Product code
- LRO
- FDA submissions
- K213481
- Distribution
- US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.
Product description
Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
Code information (models, lots, serial numbers)
UDI-DI 10198459046551 Lot 25FBU754
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYNJ59097AMedline Industries, Inc. · General surgery tray1 recall0 reports
Other devices under the same FDA submission
321 devices cleared under K213481 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Centurion ART690Centurion Medical Products Corporation · General Surgery Tray4 recalls0 reports
- Centurion CVI4505Centurion Medical Products Corporation · General Surgery Tray3 recalls0 reports
- MEDLINE ECVC6355Medline Industries, Inc. · General surgery tray3 recalls0 reports
- MEDLINE ECVC1045Medline Industries, Inc. · General surgery tray3 recalls0 reports
- Centurion ART255Centurion Medical Products Corporation · General surgery tray3 recalls0 reports
- Centurion CVI3880Centurion Medical Products Corporation · General surgery tray3 recalls0 reports
- MEDLINE ECVC1375Medline Industries, Inc. · General surgery tray3 recalls0 reports
- MEDLINE DYNDV2520Medline Industries, Inc. · General surgery tray3 recalls0 reports
- Centurion ST11670ACenturion Medical Products Corporation2 recalls0 reports
- Medline Industries, Inc. ECVC6370Centurion Medical Products Corporation · General Surgery Tray2 recalls0 reports
- MEDLINE ECVC6840Medline Industries, Inc. · General surgery tray2 recalls0 reports
- MEDLINE ECVC6265Medline Industries, Inc. · General Surgery Tray2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99667).
- Z-3207-2026 · Open, ClassifiedConvenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A
- Z-3208-2026 · Open, ClassifiedConvenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F
- Z-3210-2026 · Open, ClassifiedConvenience kits CATARACT PACK DYNJ59881A
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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