Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R
Summary
The FDA issued a Class II for Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsi by Aesculap Inc. Reason: The forceps have been used in ways not covered by the design resulting in breakage of the clamps..
Details
Source
Device Recall
External ID
Z-1312-2025
Action Date
2025-03-19
Status
Ongoing
Category
device
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.
Lot/Code Info: 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.
Quantity Affected: 47,078 forceps
Reason for Recall
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Distribution
Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-31
Company
Center Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 159 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Aesculap Inc has 23 FDA actions in our database, including 18 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aesculap Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aesculap Inc have FDA actions?
Aesculap Inc has 23 FDA actions in our database, including 18 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1312-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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