CLASS II ONGOING Device recall · Reported 19 Mar 2025 · FDA Enforcement Report
Numerous models of nonsterile hemostatic forceps: (1) REF BH100R recalled
Aesculap is recalling Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, 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-1309-2025
- 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 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, Hartmann Mosquito FCPSDELSTR1X2100MM; (7) REF BH115R, Hartmann Mosquito FCPSDELCVD1X2100MM; (8) REF BH118R, Micro-Halsted FCPS Del STR 1X2125MM; (9) REF BH119R, Micro-Halsted FCPS Del CVD 1X2125MM; (10) REF BH120R, Halsted-Mosquito FCPSDELSTR1X2125MM; (11) REF BH121R, Halsted-Mosquito FCPS DELCVD1X2125MM; (12) REF BH130R, Providence-Hosp FCPS Del STR140MM; (13) REF BH131R, Providence-Hosp FCPS Del CVD 140MM; (14) REF BH134R, Kelly Forceps Del STR 140MM; (15) REF BH135R, Kelly Forceps Del CVM 140MM; (16) REF BH139R, Dandy Delicate Forceps CVD140MM; (17) REF BH140R, Baby Crile Forceps Del STR 140MM; (18) REF BH141R, Baby Crile FORCEPSDELCVD140MM; (19) REF BH143R, Dandy Del FCPS LAT-CVD 1X2 140MM; (20) REF BH144R, Crile Forceps STR 140MM; (21) REF BH145R, Crile Forceps CVD 140MM; (22) REF BH150R, Baby Kocher Forceps STR 140MM; (23) REF BH151R, Kocher Forceps Del CVD 1X2140MM; (24) REF BH154R, Crile Forceps Del STR 1X2 140MM; (25) REF BH155R, Crile Forceps Del CVD 1X2 140MM; (26) REF BH160R, Leriche Delicate Forceps STR 150MM; (27) REF BH161R, Leriche Delicate Forceps CVD 150MM; (28) REF BH164R, Rankin FCPS Long Kelly Del STR160MM; (29) REF BH166R, Crile Forceps STR 160MM; (30) REF BH170R, Leriche Delicate Forceps STR 1X2150MM; (31) REF BH171R, Leriche Delicate Forceps CVD1X2150MM; (32) REF BH176R, Crile Forceps STR 1X2160MM; (33) REF BH177R, Crile Forceps CVD 1X2 160MM; (34) REF BH178R, Dixon-Lovelace Artery FCPS.1X2T.STR.160; (35) REF BH197R, Birkett Delicate Forceps CVD185MM; (36) REF BH199R, Nissen Delicate Forceps CVP 185MM; (37) REF BH200R, Adson Delicate Forceps STR185MM; (38) REF BH201R, Adson Delicate Forceps CVD 185MM; (39) REF BH202R, Halsted Delicate Forceps STR 185MM; (40) REF BH203R, Halsted Delicate Forceps CVD 185MM; (41) REF BH205R, Adson Hemostatic FCPS CVD.215MM; (42) REF BH206R, Heiss Delicate Forceps STR 200MM; (43) REF BH207R, Heiss Delicate Forceps CVD 200MM; (44) REF BH210R, Halsted-Mosquito Forceps DELSTR200MM; (45) REF BH211R, Halsted-Mosquito FCPS Del CVD 200MM; (46) REF BH212R, Halsted-Mosquito FCPSDELSTR1X2185MM; (47) REF BH213R, Halsted-Mosquito FCPSDELCVD1X2185MM; (48) REF BH214R, Halsted-Mosq.FCPSDELSTR1X2 200MM; (49) REF BH215R, Halsted-Mosq.FCPSDELCVD 1X2 200MM; (50) REF BH224R, Sarot Delicate Forceps 240MM; (51) REF BH225R, Crafoord Delicate Forceps CVD 245MM; (52) REF BH227R, Artery Forceps Crafoord MODIF.240MM; (53) REF BH228R, Bengolea Delicate Forceps STR 245MM; (54) REF BH229R, Bengolea Delicate Forceps CVD 245MM; (55) REF BH230R, Bridge Delicate Forceps STR 275MM; (56) REF BH231R, Bridge Delicate Forceps CVD 275MM; (57) REF BH234R, Sarot Delicate Forceps STR 1X2240MM; (58) REF BH316R, Pean Artery Forceps STR.165MM; (59) REF BH332R, Spencer-Wells Forceps STR130MM; (60) REF BH333R, Spencer-Wells Forceps CVD 130MM; 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) BH100R - 04038653139064; (2) BH104R - 04038653025558; (3)BH105R - 04038653025565; (4) BH108R - 04038653025572; (5) BH109R - 04038653025589; (6) BH114R - 04038653025619; (7) BH115R - 04038653025626; (8) BH118R - 04038653025633; (9) BH119R - 04038653025640; (10) BH120R - 04038653025657; (11) BH121R - 04038653025664; (12) BH130R - 04038653025725; (13) BH131R - 04038653025732; (14) BH134R - 04038653025749; (15) BH135R - 04038653025756; (16) BH139R - 04038653025763; (17) BH140R - 04038653025770; (18) BH141R - 04038653025787; (19) BH143R - 04038653139088; (20) BH144R - 04038653025794; (21) BH145R - 04038653025800; (22) BH150R - 04038653025817; (23) BH151R - 04038653025824; (24) BH154R - 04038653025831; (25) BH155R - 04038653025848; (26) BH160R - 04038653025855; (27) BH161R - 04038653025862; (28) BH164R - 04038653025879; (29) BH166R - 04038653025893; (30) BH170R - 04038653025923; (31) BH171R - 04038653025930; (32) BH176R - 04038653025947; (33) BH177R - 04038653025954; (34) BH178R - 04038653025961; (35) BH197R - 04038653026012; (36) BH199R - 04038653026036; (37) BH200R - 04038653026043; (38) BH201R - 04038653026050; (39) BH202R - 04038653026067; (40) BH203R - 04038653026074; (41) BH205R - 04038653411542; (42) BH206R - 04038653026081; (43) BH207R - 04038653026098; (44) BH210R - 04038653026111; (45) BH211R - 04038653026128; (46) BH212R - 04038653026135; (47) BH213R - 04038653026142; (48) BH214R - 04038653026159; (49) BH215R - 04038653026166; (50) BH224R - 04038653026203; (51) BH225R - 04038653026210; (52) BH227R - 04038653026227; (53) BH228R - 04038653026234; (54) BH229R - 04038653026241; (55) BH230R - 04038653026258; (56) BH231R - 04038653026265; (57) BH234R - 04038653026272; (58) BH316R - 04038653026357; (59) BH332R - 04038653026371; (60) BH333R - 04038653026388; (61) BH334R - 04038653026395; (62) BH335R - 04038653026401; (63) BH336R - 04038653026418; (64) BH337R - 04038653026425; (65) BH339R - 04038653026449; (66) BH410R - 04038653139101; (67) BH412R - 04038653026487; (68) BH413R - 04038653026494; (69) BH414R - 04038653026500; (70) BH415R - 04038653026517; (71) BH422R - 04038653026524; (72) BH424R - 04038653026531; (73) BH425R - 04038653026548; (74) BH442R - 04038653026555; (75) BH443R - 04038653026562; (76) BH444R - 04038653026579; (77) BH445R - 04038653026586; (78) BH446R - 04038653026593; (79) BH447R - 04038653026609; (80) BH448R - 04038653026616; (81) BH449R - 04038653026623; (82) BH450R - 04038653026630; (83) BH451R - 04038653026647; (84) BH456R - 04046963068783; (85) BH470R - 04038653026654; (86) BH471R - 04038653026661; (87) BH472R - 04038653026678; (88) BH473R - 04038653026685; (89) BH474R - 04038653026692; (90) BH612R - 04038653026722; (91) BH614R - 04038653026739; (92) BH615R - 04038653026746; (93) BH618R - 04038653026753; (94) BH619R - 04038653026760; (95) BH630R - 04038653026777; (96) BH631R - 04038653026784; (97) BH642R - 04038653026791; (98) BH643R - 04038653026807; (99) BH644R - 04038653026814; (100) BH645R - 04038653026821; (101) BH646R - 04038653026838; (102) BH647R - 04038653026845; (103) BH648R - 04038653026852; (104) BH649R - 04038653026869; (105) BH650R - 04038653026876; (106) BH651R - 04038653026883; (107) BH652R - 04038653026890; (108) BH653R - 04038653026906; (109) BH654R - 04038653026913; (110) BH655R - 04038653026920; (111) BH800R - 04038653139118; (112) BH801R - 04038653139125; (113) BH804R - 04038653139132; (114) BH805R - 04038653139149; (115) BH812R - 04038653026951; (116) BH831R - 04038653026982; (117) BH833R - 04038653026999; (118) MB229R - 04046963364458; and (119) MD469 - 04046963366148.
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 FB458R recalled | Aesculap | Device Malfunction | Nationwide | |
| CLASS II | Numerous models of nonsterile hemostatic forceps: (1) REF BH198R recalled | Aesculap | Device Malfunction | Nationwide |
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