Z-3164-2024Class II

1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical...

Name: Z-3164-2024 1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical...
Creator: Unimax Medical Systems Inc
Published: 2024-06-25
License: https://open.fda.gov/license/

Unimax Medical Systems Inc. / initiated 2024-06-25 / Open, Classified / root cause: design

FDA source

UNIMAX MEDICAL SYSTEMS INC began a recall of 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... on 2024-06-25. FDA classified it as Class II and gives the reason as "The tube may fall into the surgical site during the grasping process". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-3164-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-25
Posted: 2024-09-17
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;
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: The tube may fall into the surgical site during the grasping process.
Root cause tag: design
FDA 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 in commerce: 81,241 endo retrieval pouches
Distribution: US Nationwide distribution in the states of GA, MO, and PA.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3164-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3164-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-17

Product code GCJ

K103510Class IIUnimax Specimen Retrieval SystemUnimax Medical Systems, Inc. / cleared 2011-05-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)