Laparotomy Pack — Class II medical device recall Z-1868-2016
Terminated recall by Windstone Medical Packaging, Inc., reported 2016-06-08, distributed nationwide. These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due
| Recall number | Z-1868-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Windstone Medical Packaging, Inc., Billings, MT, United States |
| Recall initiated | 2016-03-21 |
| Classified | 2016-06-01 |
| Reported by FDA | 2016-06-08 |
| Terminated | 2016-08-16 |
| Distributed | Nationwide (US) |
| Quantity | 386 units |
| Reason classes | sterility, packaging |
| Lot numbers | 55950, 56349, 57461, 58034, 58492, 70671, 70930, 71324, 71726, 71892, 72656, 73071, 74331, 75004, 75545 |
| Model numbers | 006268-8, 007725-8 |
Product
Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" W/L.
Reason for recall
These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.
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-1868-2016. 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.