FDA Medical Device Recalls (openFDA)
UNIMAX MEDICAL SYSTEMS INC: 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;
- Recall number
- Z-3164-2024
- Recalling firm
- UNIMAX MEDICAL SYSTEMS INC
- 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;
- Status
- Open, Classified
- Initiated
- 2024-06-25
- Posted
- 2024-09-17
- Terminated
- not on file
- Reason
- The tube may fall into the surgical site during the grasping process.
- Root cause
- Device Design
- Action
- The recalling firm issued letters dated 6/25/2024 to two distributors and dated 6/27/2024 to one distributor. The letters were issued via email beginning 6/25/2024. The letter provided the reason for recall and the actions to be taken, which included: (1) Identify the affected devices at your facility and complete the Acknowledgement and Receipt Form; (2) Distribute the notification to relevant people/facilities to where the affected lots have been distributed. (3) Quarantine the affected devices and implement the destruction after receiving confirmation from UNIMAX. A list of catalog numbers and lot numbers was enclosed. If the consignee had the affected product, they were to list the catalog number, lot number, and quantity in their possession on the Acknowledgement and Receipt Form. They were to also indicate whether they have notified the relevant person/facility to where the affected lot had been distributed and indicate they have quarantined the affected devices for destruction. The form was to be emailed to the recalling firm.
- Quantity
- 81,241 endo retrieval pouches
- Distribution
- US Nationwide distribution in the states of GA, MO, and PA.
- Lot, serial or model codes
- 1. REF TM2001 - Lot numbers 6252207033, 6252211139, and 6252304152, UDI-DI 00851695005104; 2. REF TM2000 - Lot numbers 6252207032, 6252211138, and 6252304151, UDI-DI 00851695005098; 3. REF TM2002 - Lot numbers 6252207034, 6252211140, and 6252304153, UDI-DI 00851695005111; 4. REF FEP936116 - Lot number 6252303126, UDI-DI 04714127863504; 5. REF FEP979000 - Lot number 6252207216, UDI-DI 04714127863573; 6. REF SB936 - Lot numbers 6252207165, 6252207184, 6252207186, 6252304017, 6252304033, 6252305036, 6252305087, UDI-DI 0471412786076; 7. REF SB957 - Lot numbers 6252207180, 6252211177, 6252211178, 6252303004, 6252303018, 6252304025, 6252304034, 6252304046, UDI-DI 04714127860770; 8. REF SB979 - Lot numbers 6252207022, 6252207182, 6252303007, 6252303017, 6252304026, 6252304035, 6252304047, UDI-DI 04714127860909; 9. REF SB979-CA - Lot numbers 6252212124, 6252207201, 6252209205, UDI-DI 04714127861395; 10. REF SB936-CA - Lot number 6252212017, UDI-DI 04714127861371.
- 510(k) numbers
- ["K103510"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 3007791595
- Firm city
- Hsin Tien
- Firm state
- not on file
- Firm country
- Taiwan
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28