Recall archive / FDA device enforcement
Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM; (2) REF BH104R, Hartman... — FDA record Z-1309-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 31, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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 Arter...
- Reason
- The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
- Classification
- Class II
- Recalling firm
- Aesculap Inc
- Quantity
- 917,965 forceps
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1309-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Mar 19, 2025
- Recall initiation date
- Jan 31, 2025
- Center classification date
- Mar 11, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.