FDA Device recall Z-3164-2024

1. Tech Medical Services Inc

FDA Device
Class II
ongoing
Published 2024-09-25

On 2024-09-25 the FDA classified a Class II recall of 1. Tech Medical Services Inc by Unimax Medical Systems, citing the tube may fall into the surgical site during the grasping process.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-3164-2024
Classification	Class II
Status	ongoing
Initiated	2024-06-25
Published	2024-09-25
Last updated	2026-09-13 11:57 UTC
Company	Unimax Medical Systems
Distribution	US

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

The tube may fall into the surgical site during the grasping process.

Identifiers

code_info	1. REF TM2001 - Lot numbers 6252207033, 6252211139, and 6252304152, UDI-DI 00851695005104; 2. REF TM2000 - Lot numbers… 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.

code_info

1. REF TM2001 - Lot numbers 6252207033, 6252211139, and 6252304152, UDI-DI 00851695005104; 2. REF TM2000 - Lot numbers…

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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3164-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.