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

FDA Device Recall #Z-3164-2024 — Class II — June 25, 2024

Recall Summary

Recall Number Z-3164-2024
Classification Class II — Moderate risk
Date Initiated June 25, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm UNIMAX MEDICAL SYSTEMS INC
Location Hsin Tien
Product Type Devices
Quantity 81,241 endo retrieval pouches

Product Description

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.

Distribution Pattern

US Nationwide distribution in the states of GA, MO, and PA.

Lot / Code Information

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.

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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