Hobbs Medical Grasping Forceps Recalled for Incorrect Expiration Date Labeling
Hobbs Medical, Inc. is recalling Grasping Forceps due to incorrect expiration dates on device labels. Affected devices may be used beyond their safe shelf life if the mislabeled expiration dates are not corrected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with a labeling error affecting expiration dating. No illnesses or injuries have been reported. This is a risk-of-harm product where incorrect labeling could result in use of expired sterile surgical equipment, meeting the High severity criterion.
Plain-English summary
Hobbs Medical, Inc. is recalling Grasping Forceps, Catalog Number 5004, due to incorrect expiration dates displayed on device labels. The affected device labels show expiration dates that extend the shelf life beyond the actual safe period for the device.
The affected devices were distributed in the United States from March 25, 2018, to September 28, 2020, with incorrect expiration dates on labels between November 1, 2022, and September 1, 2025. Affected units are identified by lot numbers ending in 'R' or kits containing at least one device with a lot number ending in 'R'. The recall also includes devices distributed to Canada, Austria, Belgium, Finland, and Norway.
Customers who possess these forceps should take appropriate action. Incorrect expiration dating on a medical device could result in use of sterile equipment beyond its assured shelf life. Contact Hobbs Medical, Inc. for further instructions regarding the return or replacement of affected devices.
The recalled product
- Product
- Hobbs Medical Grasping Forceps Catalog Number:5004
- Manufacturer
- Hobbs Medical, Inc.
- Hazard
- mislabeling
- expiration-date-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: M84950040 Lot Numbers: H01-17-090R
Distribution
Distributed nationwide across the United States.
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