CLASS II ONGOING Device recall · Reported 19 Mar 2025 · FDA Enforcement Report

Numerous models of nonsterile hemostatic forceps: (1) REF BH951R recalled

Aesculap is recalling Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, distributed nationwide in the US. The recall was initiated on 31 Jan 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN 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.

Quantity recalled47,078 forceps

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-1312-2025
FDA event ID: 96223
Recalling firm: Aesculap, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 31 Jan 2025
FDA classified: 11 Mar 2025
Reported: 19 Mar 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

31 Jan 2025	Recall initiated by company
11 Mar 2025	Classified by FDA	+39 days
19 Mar 2025	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

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.

Nationwide Puerto Rico

Questions about this recall

Is Numerous models of nonsterile hemostatic forceps: (1) REF BH951R recalled?

Yes. Aesculap recalled Numerous models of nonsterile hemostatic forceps: (1) REF BH951R on 31 Jan 2025. The recall is Class II and its status is Ongoing. Recall number Z-1312-2025.

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.

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.

More recalls from Aesculap

All 40

Reported	Class	Recall	Company	Reason	Where
11 Mar 2026Device	CLASS II	Minop Trocar 4 Wking Channel6 recalled by Aesculap	Aesculap	Device Malfunction	Nationwide
5 Nov 2025Device	CLASS II	Sealing Unit For Trocars recalled by Aesculap	Aesculap	Packaging Defects	Nationwide
5 Nov 2025Device	CLASS II	Sealing Cap For Trocars recalled by Aesculap	Aesculap	Packaging Defects	Nationwide
5 Nov 2025Device	CLASS II	Reducing Converter To recalled by Aesculap	Aesculap	Packaging Defects	Nationwide
5 Nov 2025Device	CLASS II	Sealing Unit F/ Trocars W.reducer recalled by Aesculap	Aesculap	Packaging Defects	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide