Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD...
FDA Device Recall #Z-1312-2025 — Class II — January 31, 2025
Recall Summary
| Recall Number | Z-1312-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 31, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Aesculap Inc |
| Location | Center Valley, PA |
| Product Type | Devices |
| Quantity | 47,078 forceps |
Product Description
Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R, Negus Tonsil Forceps X-HVY-CVD190MM; (3) REF BH957R, Schnidt Tonsil Forceps SLT-CVD185MM; (4) REF BH959R, Schnidt Tonsil Forceps CVD 185MM; (5) REF BH961R, Schnidt Tonsil FCPSOPEN-RINGCVD 185MM; (6) REF BH963R, Schnidt Tonsil FCPSOPEN-RINGCVD185MM; and (7) REF BH965R, Wilson Tonsil Forceps 190MM.
Reason for Recall
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Distribution Pattern
Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.
Lot / Code Information
GTIN numbers: (1) REF BH951R - 04038653027026; (2) REF BH952R - 04038653139200; (3) REF BH957R - 04038653027033; (4) REF BH959R - 04038653027040; (5) REF BH961R - 04038653027057; (6) REF BH963R - 04038653027064; and (7) REF BH965R - 04038653027071.
Other Recalls from Aesculap Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1485-2026 | Class II | Brand Name: AESCULAP Product Name: MINOP TROCA... | Jan 15, 2026 |
| Z-0311-2026 | Class II | Brand Name: AESCULAP Product Name: SEALING UNI... | Sep 24, 2025 |
| Z-0309-2026 | Class II | Brand Name: Aesculap Product Name: SEALING UNI... | Sep 24, 2025 |
| Z-0312-2026 | Class II | Brand Name: AESCULAP Product Name: REDUCING CO... | Sep 24, 2025 |
| Z-0310-2026 | Class II | Brand Name: Aesculap Product Name: SEALING CAP... | Sep 24, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.