Non-sterile procedural trays labeled as LAPAROTOMY CDS — Class II medical device recall Z-1031-2023
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2023-02-08, distributed nationwide. Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil la
| Recall number | Z-1031-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2022-11-17 |
| Classified | 2023-01-27 |
| Reported by FDA | 2023-02-08 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10889942401291, 40889942401292 |
| Lot numbers | 22HMD613, 22JMB665 |
| Model numbers | CDS980894A |
Product
Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1031-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.