Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number:
Pending LLM rewrite. Source: FDA_DEVICE Z-1421-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
The recalled product
- Product
- Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) CDS940087AG
- UDI-DI: 10193489847260(each)
- 40193489847261(case)
- Lot Number: 21EBC900
- 2) CDS940087AI
- UDI-DI: 10193489933758(each)
- 40193489933759(case)
- Lot Number: 22GBE442
- 3) CDS940087AI
- Lot Number: 22EBG548
- 4) CDS940087AI
- Lot Number: 22EBF695
- 5) CDS940087AI
- Lot Number: 22EBA274
- 6) CDS940087AI
- Lot Number: 22BBY060
- 7) CDS940087AI
- Lot Number: 21KBH163
- 8) CDS940087AI
- Lot Number: 21JBF936
Distribution
Distributed nationwide across the United States.
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