Z-1312-2025Class II

Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF...

Name: Z-1312-2025 Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF...
Creator: Aesculap Inc
Published: 2025-01-31
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2025-01-31 / Open, Classified / root cause: design

FDA source

Aesculap Inc began a recall of 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)... on 2025-01-31. FDA classified it as Class II and gives the reason as "The forceps have been used in ways not covered by the design resulting in breakage of the clamps". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1312-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-31
Posted: 2025-03-11
Recalling firm: Aesculap Inc
Product: 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.
Product code: KAE Forceps, Ent
Reason for recall: The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Root cause tag: design
FDA root cause: Use error
Action: The recalling firm issued letters dated 1/29/2025 on 1/31/2025 via certified mail return-receipt. The letter explained the reason for the correction, identified the product impacted, provided the risk to health, and the actions required for the customer/user. The actions included: (1) Review the Urgent Medical Device Correction Notification in its entirety and ensure all users within the consignee organization are informed about the correction. Post the notification where the affected products are stored. If the consignee is a distributor, they are to forward the notification to their customers. The correction is to be extended to the end user/customer level; (2) Determine the current inventory of the affected items and comply with the following instructions: (a) Use the products identified for clamping of tissue and small vessels only; (b) Inspect the products for end-of-life indicators prior to use; (c) Visually inspect the products which should be clean and free of any signs of corrosion and cracks. Check the joint and jaw in the open position from both sides (if needed, use magnification; (d) Test the function of the device, including the jaw area, for deformation and loss of tension. An Acknowledgment Form was enclosed for completion and return via FAX or email within 2 weeks of receipt, even if the total inventory in the consignee location is 0.
Quantity in commerce: 47,078 forceps
Distribution: Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1312-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1308-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-11
Z-1309-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-11
Z-1310-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-11
Z-1311-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-11
Z-1312-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-11

Product code KAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)