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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

UNIMAX MEDICAL SYSTEMS INC: Endo Retrieval Pouches Recalled Due to Tube Detachment Risk during Surgery

Agency Publication Date: September 17, 2024
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Summary

UNIMAX MEDICAL SYSTEMS INC is recalling approximately 81,241 endo retrieval pouches and pockets sold under the Tech Medical Services, UNIMAX, and ConMed Corporation brands. The recall was initiated because the product's tube may fall into a patient's surgical site during the grasping process of a surgery. This defect can lead to foreign objects being left inside a patient's body, which could cause injury or complications if not immediately recovered. These sterile surgical devices were distributed in Georgia, Missouri, and Pennsylvania. If you are a healthcare provider using these devices, you should immediately stop use and contact the manufacturer for further instructions.

Risk

The tube component of the retrieval pouch can detach and fall into the surgical field during a procedure. This poses a risk of foreign body retention within the patient, which may require prolonged surgery or additional medical intervention to retrieve the detached part.

What You Should Do

  1. Identify your product by checking the brand name and reference number on the packaging. Affected brands include Tech Medical Services (REF TM2001, TM2000, TM2002), UNIMAX (REF FEP936116, FEP979000), and ConMed Corporation (REF SB936, SB957, SB979, SB979-CA, SB936-CA).
  2. Check the lot numbers on your inventory. Affected lots include: 6252207033, 6252211139, 6252304152, 6252207032, 6252211138, 6252304151, 6252207034, 6252211140, 6252304153, 6252303126, 6252207216, 6252207165, 6252207184, 6252207186, 6252304017, 6252304033, 6252305036, 6252305087, 6252207180, 6252211177, 6252211178, 6252303004, 6252303018, 6252304025, 6252304034, 6252304046, 6252207022, 6252207182, 6252303007, 6252303017, 6252304026, 6252304035, 6252304047, 6252212124, 6252207201, 6252209205, and 6252212017.
  3. Immediately stop using any affected endo retrieval pouches and quarantine them to prevent use in surgical procedures.
  4. Contact your healthcare provider or UNIMAX MEDICAL SYSTEMS INC for further instructions regarding the return or replacement of these devices.
  5. Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information or to report adverse events.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer instructions for return or correction

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Tech Medical Services Inc. Detachable Endo Retrieval Pouch (3" x 6")
Model / REF:
REF TM2001
UDI-DI 00851695005104
Lot Numbers:
6252207033
6252211139
6252304152
Product: Tech Medical Services Inc. Detachable Endo Retrieval Pouch (5" x 7")
Model / REF:
REF TM2000
UDI-DI 00851695005098
Lot Numbers:
6252207032
6252211138
6252304151
Product: Tech Medical Services, Inc. Detachable Endo Retrieval Pouch (8" x 10")
Model / REF:
REF TM2002
UDI-DI 00851695005111
Lot Numbers:
6252207034
6252211140
6252304153
Product: UNIMAX Detachable endo pocket (3" x 6")
Model / REF:
REF FEP936116
UDI-DI 04714127863504
Lot Numbers:
6252303126
Product: UNIMAX Detachable endo pocket (8" x 10")
Model / REF:
REF FEP979000
UDI-DI 04714127863573
Lot Numbers:
6252207216
Product: ConMed Corporation Detachable endo pocket (3" x 6")
Model / REF:
REF SB936
UDI-DI 0471412786076
Lot Numbers:
6252207165
6252207184
6252207186
6252304017
6252304033
6252305036
6252305087
Product: ConMed Corporation Detachable endo pocket (5" x 7")
Model / REF:
REF SB957
UDI-DI 04714127860770
Lot Numbers:
6252207180
6252211177
6252211178
6252303004
6252303018
6252304025
6252304034
6252304046
Product: ConMed Corporation Detachable endo pocket (7.5" x 9")
Model / REF:
REF SB979
UDI-DI 04714127860909
Lot Numbers:
6252207022
6252207182
6252303007
6252303017
6252304026
6252304035
6252304047
Product: ConMed Corporation Detachable endo pocket (7.5 x 9")
Model / REF:
REF SB979-CA
UDI-DI 04714127861395
Lot Numbers:
6252212124
6252207201
6252209205
Product: ConMed Corporation Detachable endo pocket (3" x 6")
Model / REF:
REF SB936-CA
UDI-DI 04714127861371
Lot Numbers:
6252212017

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95133
Status: Active
Manufacturer: UNIMAX MEDICAL SYSTEMS INC
Sold By: Tech Medical Services Inc.; ConMed Corporation
Manufactured In: Taiwan
Units Affected: 81,241 endo retrieval pouches
Distributed To: Georgia, Missouri, Pennsylvania

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.