Recall record at a glance
| Official record | Z-1310-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Aesculap Inc. |
| Report date | Mar 19, 2025 |
| Recall initiation date | Jan 31, 2025 |
| Quantity | 93,714 forceps |
| Location | Center Valley, PA, United States |
Official product description
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 BJ021R, Overholt-Geiss Suture FCPS #1CVD205MM; (7) REF BJ022R, Overholt-Geiss Suture FCPS #2CVD220MM; (8) REF BJ023R, Overholt-Geiss Suture FCPS #3 CVD225MM; (9) REF BJ025R, Overholt-Geiss Suture FCPS #5CVD230MM; (10) REF BJ026R, Overholt-Geiss Suture FCPS #6 CVD225MM; (11) REF BJ031R, Overholt-Geiss Suture FCPS#1CVD260MM; (12) REF BJ034R, Overholt-Geiss Suture FCPS#4CVD270MM; (13) REF BJ035R, Overholt-Geiss Suture FCPS #5CVD280MM; (14) REF BJ037R, Forceps CVD Delicate 145MM; (15) REF BJ038R, Forceps CVD.Delicate 185MM; (16) REF BJ039R, Forceps CVD.Delicate 235MM; (17) REF BJ041R, Rumel Suture Forceps SLT-CVD 240MM; (18) REF BJ042R, Rumel Suture Forceps CVD 240MM; (19) REF BJ043R, Rumel Suture Forceps MED-CV 240MM; (20) REF BJ044R, Rumel Suture Forceps HVY-CV 240MM; (21) REF BJ045R, Rumel Suture Forceps RT-ANG# 5 240MM; (22) REF BJ047R, Zenker Suture Forceps SLT-CVD 300MM; (23) REF BJ048R, Zenker Suture Forceps HVY-CVD 290MM; (24) REF BJ050R, Mixter-O'Shaugnessy Forceps CVD190MM; (25) REF BJ051R, Wikstroem Suture Forceps RT-ANG 205MM; (26) REF BJ052R, Finochietto Suture FCPCVDW/HOLE245MM; (27) REF BJ055R, Mixter Suture Forceps Rt-Ang 230MM; (28) REF BJ057R, Kantrowitz Thoracic Clamp 200MM; (29) REF BJ058R, Kantrowitz Thoracic Clamp 245MM; (30) REF BJ059R, Kantrowitz Thoracic Clamp 275MM; (31) REF BJ060R, Lahey Forceps Long-Serr 225MM; (32) REF BJ061R, Mixter Forceps Long-Serr220MM; (33) REF BJ062R, Mixter Forceps Long-Serr 250MM; (34) REF BJ068R, Lahey DISS.A.LIGAT.FORCEPS 230MM; (35) REF BJ070R, Lawrence Suture FCPS DEL CVDD 270MM; (36) REF BJ073R, Mixter Forceps Long-Serr 290MM; (37) REF BJ080R, Overholt Forceps # 0 CVD215MM; (38) REF BJ081R, Overholt Forceps # 1 CVD210MM; (39) REF BJ082R, Overholt Forceps # 2 CVD 220MM; (40) REF BJ083R, Overholt Forceps # 3 CVD 225MM; (41) REF BJ086R, Overholt Forceps # 6 CVD 225MM; (42) REF BJ090R, Overholt Forceps # 0 CVD 295MM; (43) REF BJ091R, Overholt Forceps # 1 CVD 295MM; (44) REF BJ096R, Overholt Forceps # 6 CVD 300MM; (45) REF BJ100R, Gemini Clamp RT-ANG140MM; (46) REF BJ102R, Gemini Clamp RT-ANG 180MM; (47) REF BJ103R, Gemini Clamp RT-ANG 200MM; (48) REF BJ104R, Gemini Clamp RT-ANG 230MM; (49) REF BJ106R, Gemini Clamp RT-ANG 280MM; (50) REF BJ120R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 160MM; (51) REF BJ121R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 180MM; (52) REF BJ122R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 200MM; (53) REF BJ123R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 220MM; (54) REF BJ130R, Zenker DISS & LIG FCPSSLT-CVD 350MM; (55) REF BJ131R, Zenker DISS & LIG FCPS CVD 350MM; continued
Why the product was recalled
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Distribution information
Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
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