The Recall Desk
HighFDA (Devices)·Z-0035-2023·Announced 2022-10-19

Hobbs Medical Grasping Forceps Recalled for Incorrect Expiration Dates

Hobbs Medical Grasping Forceps (Catalog 5008) were distributed with incorrect expiration dates that extend shelf life beyond the device's actual safe use period. Affected units with lot numbers ending in 'R' were distributed from March 2018 to September 2020.

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: This is an FDA Class II recall of a surgical instrument with incorrect shelf-life labeling. While no injuries or illnesses are reported, the mislabeled expiration dates create a risk-of-harm scenario where expired instruments could degrade and fail during patient procedures.

Plain-English summary

Hobbs Medical, Inc. is recalling Grasping Forceps (Catalog Number 5008) distributed between March 25, 2018 and September 28, 2020. The device labels display incorrect expiration dates that extend the shelf life beyond the product's actual safe use period. Affected units have lot numbers ending in 'R' or are kits containing at least one device with a lot number ending in 'R' (UDI-DI: M84950080; specific lot numbers H10-17-211R and H09-17-086R).

Surgical instruments must be used within their intended expiration dates to ensure proper functionality and sterility. An extended shelf life due to mislabeled expiration dates could result in use of degraded devices that may fail during surgical procedures, potentially compromising patient safety.

A total of 14 units were affected by this recall. The devices were distributed worldwide, including the United States, Canada, Austria, Belgium, Finland, and Norway.

Healthcare providers and users should verify the lot numbers and expiration dates of their Hobbs Medical Grasping Forceps. Any affected devices should be removed from service and not used. Users who may have been affected should contact Hobbs Medical, Inc. for further instructions or replacement devices.

The recalled product

Product
Hobbs Medical Grasping Forceps Catalog Number: 5008
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Surgical Instruments
Hazard
  • incorrect-expiration-date

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: M84950080 Lot Numbers: H10-17-211R H09-17-086R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category