CLASS II ONGOING Device recall · Reported 15 Nov 2023 · FDA Enforcement Report
Disposable Spetzler-Malis Bipolar forceps SM Disp Bayonet Tip recalled
Stryker is recalling Disposable Spetzler-Malis Bipolar forceps SM Disp Bayonet Tip, distributed nationwide in the US. The recall was initiated on 11 Sep 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0242-2024
- FDA event ID
- 93211
- Recalling firm
- Stryker, Portage, MI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Sep 2023
- FDA classified
- 7 Nov 2023
- Reported
- 15 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 11 Sep 2023 | Recall initiated by company | |
| 7 Nov 2023 | Classified by FDA | +57 days |
| 15 Nov 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Product as listed by the FDA
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-230-005
Where it was distributed
US Nationwide. Australia, Canada, Japan, Korea, Singapore.
Questions about this recall
Is Disposable Spetzler-Malis Bipolar forceps SM Disp Bayonet Tip recalled?
Yes. Stryker recalled Disposable Spetzler-Malis Bipolar forceps SM Disp Bayonet Tip on 11 Sep 2023. The recall is Class II and its status is Ongoing. Recall number Z-0242-2024.
Why was it recalled?
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Which lots are affected?
GTIN: 7613327300253; Lot Numbers: 200507007, 200515006, 201203014
Where was it sold?
US Nationwide. Australia, Canada, Japan, Korea, Singapore.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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