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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

Steris Corporation: Steris Hookup Accessories Recalled Due to Illegible Identification Labels

Agency Publication Date: December 22, 2023
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Summary

Steris Corporation is recalling 2,545 units of various Hookup Accessories used with Medivators Advantage Plus and Advantage Plus Pass Thru automated endoscope reprocessors. The identification labels on these hookups can become unreadable over time because the ink may come off. This defect makes it difficult for medical staff to identify the correct hookup for specific medical procedures, which can lead to delays in patient care. These affected accessories were distributed between July 17 and September 27, 2023.

Risk

If the label ink wears off, users cannot properly identify the accessory, which may lead to the postponement of critical endoscopic medical procedures. While no injuries have been reported, the inability to verify equipment compatibility poses a risk to hospital workflow and patient scheduling.

What You Should Do

  1. Check your inventory for Steris Hookup Accessories purchased or distributed between July 17, 2023, and September 27, 2023.
  2. Identify affected products by matching the Model Numbers and UDI codes on your equipment, such as Model 2-8-010 (UDI 00677964068478) or Model 2-8-210 (UDI 00677964068485), against the extensive list of over 100 affected models.
  3. Inspect the identification labels on these hookups to determine if the ink is fading or becoming illegible.
  4. Contact Steris Corporation at 1-888-463-6332 or visit their website to receive instructions on how to handle affected units and to determine if a replacement or remedy is available.
  5. Consult with your healthcare facility's risk management or clinical engineering department regarding the continued use of hookups with illegible labeling.
  6. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Label integrity check and identification verification.

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

Affected Products

Product: HU ZERO CHANNEL NO LT Hookup Accessory
Model / REF:
2-8-001
2-8-001HAN
UPC Codes:
00677964068515
00677964064739
Date Ranges: July 17 - September 27, 2023
Product: ASSY, HOOK-UP, OLYMPUS Hookup Accessory
Model / REF:
2-8-010
2-8-010HAN
UPC Codes:
00677964068478
00677964001802
Date Ranges: July 17 - September 27, 2023
Product: HOOKUP, OPTIM LT Hookup Accessory
Model / REF:
2-8-014
UPC Codes:
00677964095177
Date Ranges: July 17 - September 27, 2023
Product: ASSY, HOOKUP, PENTAX-0K Hookup Accessory
Model / REF:
2-8-030
2-8-030HAN
UPC Codes:
00677964071348
00677964037399
Date Ranges: July 17 - September 27, 2023
Product: ASSY, HKUP STORZ 0K Hookup Accessory
Model / REF:
2-8-040
UPC Codes:
00677964072284
Date Ranges: July 17 - September 27, 2023
Product: ASSY, HU VISION SCIENCE Hookup Accessory
Model / REF:
2-8-070
UPC Codes:
00677964094637
Date Ranges: July 17 - September 27, 2023
Product: ASSY, HOOKUP OLMPUS 1K Hookup Accessory
Model / REF:
2-8-112
2-8-112HAN
UPC Codes:
00677964071300
00677964001819
Date Ranges: July 17 - September 27, 2023
Product: ASSY, HOOKUP FUJI 1K Hookup Accessory
Model / REF:
2-8-120
UPC Codes:
00677964102080
Date Ranges: July 17 - September 27, 2023
Product: ASSY, HOOK-UP OLYMPUS 2K Hookup Accessory
Model / REF:
2-8-210
2-8-210HAN
UPC Codes:
00677964068485
00677964001826
Date Ranges: July 17 - September 27, 2023
Product: ASSY, HOOKUP, OLYMPUS-2K Hookup Accessory
Model / REF:
2-8-213
2-8-213HAN
UPC Codes:
00677964070648
00677964001871
Date Ranges: July 17 - September 27, 2023
Product: ASSY HOOKUP OLY 2K Hookup Accessory
Model / REF:
2-8-218
2-8-218HAN
UPC Codes:
00677964072369
00677964061707
Date Ranges: July 17 - September 27, 2023
Product: ASSY, HOOKUP FUJINON 2K Hookup Accessory
Model / REF:
2-8-236
UPC Codes:
00677964072376
Date Ranges: July 17 - September 27, 2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93566
Status: Active
Manufacturer: Steris Corporation
Sold By: Steris Corporation; Authorized Medical Distributors
Manufactured In: United States
Units Affected: 2545 US; 992 OUS
Distributed To: Nationwide

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.

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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.