Stryker Disposable Bipolar Forceps Recalled for Incorrect Expiration Date Labeling
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to an expiration date labeling error. The label incorrectly shows a 54-month shelf life when the actual shelf life is 36 months.
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 a Class II medical device with an expiration date labeling error that creates risk of use beyond the validated 36-month shelf life, potentially compromising sterility and performance. No illnesses or injuries have been reported, placing this in the 'risk-of-harm without reported injury' category.
Plain-English summary
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps (Catalog Number 6780-200-015) due to an expiration date labeling error. The product label incorrectly indicates a shelf life of 54 months (4.5 years), while the correct shelf life is 36 months (3 years).
These surgical instruments have been distributed throughout the United States and internationally to Australia, Canada, Japan, Korea, and Singapore. The affected lot numbers are: 200525012, 200716010, 200731013, and 200806013.
The labeling error could result in these products being retained and used beyond their validated 36-month shelf life, which may compromise product sterility and performance.
The recalled product
- Product
- Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-200-015
- Manufacturer
- Stryker Corporation
- Hazard
- Affected units
- 2,321
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 (5)
- GTIN: 7613327300314
- Lot Numbers: 200525012
- 200716010
- 200731013
- 200806013
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 19 products in this recall →Related recalls
Same manufacturer · Stryker Corporation
See all →- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighStryker Single Spike Tube Set Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
Same hazard · shelf life mislabeling
See all →- HighTissium Peripheral Nerve Repair Device Shelf Life Recall
FDA (Devices) · 2026-08-12
- ModeratenanOss 3D Bone Graft Substitute Incorrectly Labeled with Five-Year Shelf Life
FDA (Devices) · 2026-04-29
- ModerateMedline Bleach Germicidal Wipes Recalled for Incorrect Shelf-Life Labeling
FDA (Devices) · 2024-02-28
- ModerateStryker surgical forceps recall due to incorrect expiration date labeling
FDA (Devices) · 2023-11-15
- HighDisposable Spetzler-Malis Bipolar Forceps Recalled for Incorrect Shelf Life Label
FDA (Devices) · 2023-11-15