Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM; (...
FDA Device Recall #Z-1309-2025 — Class II — January 31, 2025
Recall Summary
| Recall Number | Z-1309-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 31, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Aesculap Inc |
| Location | Center Valley, PA |
| Product Type | Devices |
| Quantity | 917,965 forceps |
Product Description
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
Reason for Recall
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Distribution Pattern
Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.
Lot / Code Information
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.
Other Recalls from Aesculap Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1485-2026 | Class II | Brand Name: AESCULAP Product Name: MINOP TROCA... | Jan 15, 2026 |
| Z-0311-2026 | Class II | Brand Name: AESCULAP Product Name: SEALING UNI... | Sep 24, 2025 |
| Z-0309-2026 | Class II | Brand Name: Aesculap Product Name: SEALING UNI... | Sep 24, 2025 |
| Z-0312-2026 | Class II | Brand Name: AESCULAP Product Name: REDUCING CO... | Sep 24, 2025 |
| Z-0310-2026 | Class II | Brand Name: Aesculap Product Name: SEALING CAP... | Sep 24, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.