Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per… recallZ-1030-2023 · 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

Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in 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 11/21/2022. Consignees were instructed to over-label the sterile kits with a warning label indicating Warning To Avoid Injury, Please Handle Blades with Care . For the Non-Sterile kits, they are to over label the affected kits indicating to remove the blades and replace from a different sterile supply. No product is to be returned. Customers were also instructed to complete and return the response form.

Recall details

Recall number: Z-1030-2023
Status: Open, Classified
Initiated by the company: Nov 17, 2022
Posted by the FDA: Jan 27, 2023
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 260 cases (520 units)
Product code: FDE
Distribution: US Nationwide distribution in the states of AR, MD, WA, WI.

Product description

Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case

Code information (models, lots, serial numbers)

Item Number: DYNJ900415L, UDI/GTIN Case: 40195327029426, UDI/GTIN Each: 10195327029425, Lot Numbers: 22HBO658, 22JBV699

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Medline Industries, Inc. DYNJ900415L
Medline Industries, Inc. · laparoscopy kit
2 recalls0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 91387).

Z-1029-2023 · Open, Classified
Non-sterile procedural trays labeled as CRANI, 2 per case
Z-1031-2023 · Open, Classified
Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case
Z-1032-2023 · Open, Classified
Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
Z-1033-2023 · Open, Classified
Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case
Z-1034-2023 · Open, Classified
Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case
Z-1035-2023 · Open, Classified
Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case

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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