CLASS II ONGOING Device recall · Reported 19 Mar 2025 · FDA Enforcement Report
Numerous models of nonsterile hemostatic forceps: (1) REF BH198R recalled
Aesculap is recalling Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, 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
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-1310-2025
- 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
- Device Malfunction
- 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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
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.
Questions about this recall
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 BH198R - 04038653026029; (2) REF BH304R - 04038653026333; (3) REF BH813R - 04038653026968; (4) REF BJ016R - 04038653027163; (5) REF BJ020R - 04038653027200; (6) REF BJ021R - 04038653027217; (7) REF BJ022R - 04038653027224; (8) REF BJ023R - 04038653027231; (9) REF BJ025R - 04038653027255; (10) REF BJ026R - 04038653027262; (11) REF BJ031R - 04038653027279; (12) REF BJ034R - 04038653027309; (13) REF BJ035R - 04038653027316; (14) REF BJ037R - 04046963458201; (15) REF BJ038R - 04046963458218; (16) REF BJ039R - 04046963458225; (17) REF BJ041R - 04038653027323; (18) REF BJ042R - 04038653027330; (19) REF BJ043R - 04038653027347; (20) REF BJ044R - 04038653027354; (21) REF BJ045R - 04038653027361; (22) REF BJ047R - 04038653027378; (23) REF BJ048R - 04038653027385; (24) REF BJ050R - 04038653139224; (25) REF BJ051R - 04038653027392; (26) REF BJ052R - 04038653139231; (27) REF BJ055R - 04038653027408; (28) REF BJ057R - 04038653139248; (29) REF BJ058R - 04038653139255; (30) REF BJ059R - 04038653139262; (31) REF BJ060R - 04038653139279; (32) REF BJ061R - 04038653027415; (33) REF BJ062R - 04038653027422; (34) REF BJ068R - 04038653027446; (35) REF BJ070R - 04038653139293; (36) REF BJ073R - 04046963365202; (37) REF BJ080R - 04038653027453; (38) REF BJ081R - 04038653027460; (39) REF BJ082R - 04038653027477; (40) REF BJ083R - 04038653027484; (41) REF BJ086R - 04038653027491; (42) REF BJ090R - 04038653027507; (43) REF BJ091R - 04038653027514; (44) REF BJ096R - 04038653027521; (45) REF BJ100R - 04038653027538; (46) REF BJ102R - 04038653027545; (47) REF BJ103R - 04038653027552; (48) REF BJ104R - 04038653027569; (49) REF BJ106R - 04038653027576; (50) REF BJ120R - 04038653027606; (51) REF BJ121R - 04038653027613; (52) REF BJ122R - 04038653027620; (53) REF BJ123R - 04038653027637; (54) REF BJ130R - 04038653256457; (55) REF BJ131R - 04038653256464; (56) REF BJ132R - 04038653256471; (57) REF FB440R - 04038653155897; (58) REF FB441R - 04038653155903; (59) REF FB442R - 04038653155910; (60) REF FB443R - 04038653155927; (61) REF FB446R - 04038653155958; (62) REF FB447R - 04038653155965; (63) REF FB448R - 04038653155972; (64) REF FB483R - 04038653156306; (65) REF FB486R - 04038653156337; (66) REF FB487R - 04038653156344; (67) REF FB496R - 04038653156436; (68) REF FB498R - 04038653156450; (69) REF FB499R - 04038653156467; (70) REF FB526R - 04038653156719; (71) REF FB527R - 04038653156726; (72) REF FB533R - 04038653156771; (73) REF FB534R - 04038653156788; (74) REF FB563R - 04038653156931; (75) REF FB570R - 04038653156979; (76) REF FB741R - 04038653157716; (77) REF FB961R - 04038653158560; (78) REF MD465R - 04038653379507; (79) REF MD466R - 04038653379521; (80) REF MD467R - 04038653379545; (81) REF MD468 - 04046963366117; (82) REF MD569 - 04046963365578; and (83) REF MD570R - 04038653394999.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 96223This product is part of a recall event; the main page for the event is Numerous models of nonsterile hemostatic forceps: (1) REF BH951R recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Numerous models of nonsterile hemostatic forceps: (1) REF BH951R recalled | Aesculap | Device Malfunction | Nationwide | |
| CLASS II | Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R recalled | Aesculap | Device Malfunction | Nationwide | |
| CLASS II | Numerous models of nonsterile hemostatic forceps: (1) REF BH100R recalled | Aesculap | Device Malfunction | Nationwide | |
| CLASS II | Numerous models of nonsterile hemostatic forceps: (1) REF FB458R recalled | Aesculap | Device Malfunction | Nationwide |
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