1 — Class II medical device recall Z-3164-2024
Ongoing recall by UNIMAX MEDICAL SYSTEMS INC, reported 2024-09-25, distributed nationwide. The tube may fall into the surgical site during the grasping process.
| Recall number | Z-3164-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | UNIMAX MEDICAL SYSTEMS INC, Hsin Tien, Taiwan |
| Recall initiated | 2024-06-25 |
| Classified | 2024-09-17 |
| Reported by FDA | 2024-09-25 |
| Distributed | Nationwide (US) |
| Quantity | 81,241 endo |
| UPC / GTIN / UDI-DI | 00851695005098, 00851695005104, 00851695005111, 04714127860770, 04714127860909, 04714127861371, 04714127861395, 04714127863504, 04714127863573 |
| Lot numbers | 6252207022, 6252207032, 6252207033, 6252207034, 6252207165, 6252207180, 6252207182, 6252207184, 6252207186, 6252207201, 6252207216, 6252209205, 6252211138, 6252211139, 6252211140, 6252211177, 6252211178, 6252212017, 6252212124, 6252303004, 6252303007, 6252303017, 6252303018, 6252303126, 6252304017, 6252304025, 6252304026, 6252304033, 6252304034, 6252304035, 6252304046, 6252304047, 6252304151, 6252304152, 6252304153, 6252305036, 6252305087 |
| Model numbers | 7.5, B936, B936-CA, B957, B979, B979-CA, FEP936116, FEP979000, TM2000, TM2001, TM2002 |
Product
1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2000, 5" x 7", sterile; 3. Tech Medical Services, Inc. Detachable Endo Retrieval Pouch, REF TM2002, 8" x 10", sterile; 4. UNIMAX Detachable endo pocket, REF FEP936116, 3" x 6", sterile; 5. UNIMAX Detachable endo pocket, REF FEP979000, 8" x 10", sterile; 6. ConMed Corporation Detachable endo pocket, REF SB936, 3" x 6", sterile; 7. ConMed Corporation Detachable endo pocket, REF SB957, 5" x 7", sterile; 8. ConMed Corporation Detachable endo pocket, REF SB979, 7.5" x 9", sterile; 9. ConMed Corporation Detachable endo pocket, REF SB979-CA, 7.5 x 9", sterile; 10. ConMed Corporation Detachable endo pocket, REF SB936-CA, 3" x 6", sterile;
Reason for recall
The tube may fall into the surgical site during the grasping process.
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-3164-2024. 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.