Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM; ...

FDA Device Recall #Z-1311-2025 — Class II — January 31, 2025

Recall Summary

Recall Number Z-1311-2025
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 1,147 forceps

Product Description

Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM; (2) REF FB459R, Glover ATR.CLAMP CVD 245MM; (3) REF FB461R, Glover ATR.CLAMP 195MM; (4) REF FB462R, Glover ATR.CLAMP 210MM; (5) REF FB469R, Leland-Jones Peripheral CLMPSTR 195MM; (6) REF FB567R, Cooley Pediatric Clamp 30DG30/165MM; (7) REF FB568R, Cooley Pediatric Clamp 60DG 30/160MM; (8) REF FB569R, Cooley Pediatric Clamp 90DG30/150MM; (9) REF FB729R, Cooley Pediatric Clamp 17MM 170MM; (10) REF FB730R, Cooley Pediatric Clamp 20MM175MM; (11) REF FB736R, Cooley Pediatric Clamp 74MM 185MM; (12) REF FB737R, Cooley Pediatric Clamp 86MM 195MM; and (13) REF FB738R, Cooley Pediatric Clamp 108MM 260MM.

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 FB458R - 04038653156078; (2) REF FB459R - 04038653156085; (3) REF FB461R - 04038653156108; (4) REF FB462R - 04038653156115; (5) REF FB469R - 04038653156184; (6) REF FB567R - 04038653156948; (7) REF FB568R - 04038653156955; (8) REF FB569R - 04038653156962; (9) REF FB729R - 04038653157617; (10) REF FB730R - 04038653157624; (11) REF FB736R - 04038653157686; (12) REF FB737R - 04038653157693; and (13) REF FB738R - 04038653157709.

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.