Aesculap Inc: Device Recall

Recall Details

Recall Number

Z-1312-2025

Classification

Class II

Product Type

Device

Recalling Firm

Aesculap Inc

Status

Ongoing

Date Initiated

01/31/2025

Location

Center Valley, PA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

47,078 forceps

Reason for Recall

The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

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.

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.

Other Recalls by Aesculap Inc

• Class II: Risk 09/24/2025
  It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
• Class II: Risk 09/24/2025
  It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
• Class II: Risk 09/24/2025
  It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
• Class II: Risk 09/24/2025
  It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
• Class II: Risk 01/31/2025
  The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

View all recalls by Aesculap Inc →