The Recall Desk
ModerateFDA (Devices)·Z-0245-2024·Announced 2023-11-15

Disposable surgical forceps recalled for incorrect expiration date labeling

Stryker recalls disposable Spetzler-Malis Bipolar forceps due to expiration date labeling error. Labels show 54-month shelf life but actual shelf life is 36 months.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving a labeling error on an expiration date. No illnesses or injuries have been reported. The hazard is theoretical—potential use of devices past their actual expiration date—rather than confirmed harm, fitting the rubric criterion for 'Minor labeling errors' at Score 2.

Plain-English summary

Stryker Corporation is recalling 2,321 disposable Spetzler-Malis Bipolar forceps (Catalog Number 6770-180-005) due to incorrect expiration date labeling on the product packaging. The affected devices are from lot numbers 200525007, 200806005, and 200910009.

The product label indicates a shelf life of 54 months (4.5 years), but the actual shelf life for these products is 36 months (3 years). This discrepancy creates a risk that healthcare facilities or users could inadvertently use devices after their actual expiration date.

The recalled forceps were distributed nationwide in the United States as well as internationally to Australia, Canada, Japan, Korea, and Singapore. Healthcare facilities and users should verify any received devices against the affected lot numbers and replace them with correctly labeled units.

The recalled product

Product
Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-180-005
Manufacturer
Stryker Corporation
Hazard
  • expiration-mislabeling
  • label-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 (4)

  • GTIN: 7613327299908
  • Lot Numbers: 200525007
  • 200806005
  • 200910009

Distribution

Distributed nationwide across the United States.