Non-sterile procedural trays labeled as THEDA CLARK TOTAL… recallZ-1034-2023 · 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-1034-2023
- Status
- Open, Classified
- Initiated by the company
- Nov 17, 2022
- Posted by the FDA
- Jan 27, 2023
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 45 units
- Product code
- OJH
- Distribution
- US Nationwide distribution in the states of AR, MD, WA, WI.
Product description
Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case
Code information (models, lots, serial numbers)
Item Number: CDSOPP508AG, UDI/GTIN Case: 40195327145140, UDI/GTIN Each: 10195327145149, Lot Number: 22HBO323
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. CDSOPP508AGMedline Industries, Inc. · Orthopedic tray2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 91387).
- Z-1029-2023 · Open, ClassifiedNon-sterile procedural trays labeled as CRANI, 2 per case
- Z-1030-2023 · Open, ClassifiedNon-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case
- Z-1031-2023 · Open, ClassifiedNon-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case
- Z-1032-2023 · Open, ClassifiedNon-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
- Z-1033-2023 · Open, ClassifiedNon-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case
- Z-1035-2023 · Open, ClassifiedNon-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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