Food, drugs, devices › Aesculap Inc
Device recall: Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ501R
FDA enforcement event 96223 is a device recall by Aesculap Inc of Center Valley, PA, initiated 31 Jan 2025 and classified Class II, with 5 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Aesculap Inc has 25 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Aesculap Inc, Center Valley, PA.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1308-2025 | Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ501R, Phaneuf Hysterectomy Forceps ANG 205MM; (3) REF BJ511R, Holzbach Hyst Forceps CVD245MM; (4) REF BJ520R, Heaney Hyst Forceps Grooved 205MM; (5) REF BJ521R, Heaney Hyst Forceps Grooved 250MM; (6)… | 19,979 forceps | Class II | Ongoing | 19 Mar 2025 |
| Z-1309-2025 | Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM; (2) REF BH104R, Hartmann Mosquito FCSDEL STR 100MM; (3) REF BH105R, Hartmann Mosquito FCPSDELCVD100MM; (4) REF BH108R, Micro-Halsted Forceps DEL STR125MM; (5) REF BH109R, Micro-Halsted Forceps DEL CVM 125mm; (6) REF BH114R,… | 917,965 forceps | Class II | Ongoing | 19 Mar 2025 |
| Z-1310-2025 | Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig Artery Forceps CVD.190MM; (2) REF BH304R, Pean Artery Forceps Straight 140MM; (3) REF BH813R, Artery Forceps Curved 250MM; (4) REF BJ016R, Diss.A.Ligat.Forceps S-Shaped CVD.210MM; (5) REF BJ020R, Overholt-Geiss Suture FCPS #0CVD195MM; (6) REF… | 93,714 forceps | Class II | Ongoing | 19 Mar 2025 |
| Z-1311-2025 | 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… | 1,147 forceps | Class II | Ongoing | 19 Mar 2025 |
| Z-1312-2025 | 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)… | 47,078 forceps | Class II | Ongoing | 19 Mar 2025 |
Context
Other enforcement events for Aesculap Inc
All 25 events for Aesculap Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The forceps have been used in ways not covered by the design resulting in breakage of the clamps."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.