Laparotomy Sponge with the following product description and model… — Class II medical device recall Z-1068-2019
Terminated recall by Medical Action Industries Inc, reported 2019-04-03, distributed nationwide. Potential lack of sterility assurance
| Recall number | Z-1068-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medical Action Industries Inc, Arden, NC, United States |
| Recall initiated | 2019-03-01 |
| Classified | 2019-03-28 |
| Reported by FDA | 2019-04-03 |
| Terminated | 2021-04-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, SA |
| Reason classes | sterility |
| Model numbers | 18X18XR, 300, 400, 402, 404, 407, 411, 412, 419, 426, 450, SM40018, V300, V400, V450 |
Product
Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300, 450, SM40018, V300; 2. Lap 18X18 XR (5 each/pack, 40 pack/case) - Model Number 400, 404, V400, V450; 3. Lap 18X18 XR w/ring (5 each/pack, 40 pack/case) - Model Number 402; 4. Lap 4X18 XR (5 each/pack, 40 pack/case) - Model Number 407; 5. Lap 12X12 XR (5 each/pack, 40 pack/case) - Model Number 411; 6. Lap 12X12 XR w/ring (5 each/pack, 40 pack/case) - Model Number 412; 7. Lap 8X36 XR (5 each/pack, 40 pack/case) - Model Number 419; 8. Lap 17X26 XR (5 each/pack, 20 pack/case) - Model Number 426;
Reason for recall
Potential lack of sterility assurance
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-1068-2019. 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.