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Numerous models of nonsterile hemostatic forceps recallZ-1309-2025 · Aesculap Inc · initiated Jan 31, 2025

Class II Open, Classified All recalls posted in March 2025

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Aesculap Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

FDA root cause category: Use error

What the company is doing

The recalling firm issued letters dated 1/29/2025 on 1/31/2025 via certified mail return-receipt. The letter explained the reason for the correction, identified the product impacted, provided the risk to health, and the actions required for the customer/user. The actions included: (1) Review the Urgent Medical Device Correction Notification in its entirety and ensure all users within the consignee organization are informed about the correction. Post the notification where the affected products are stored. If the consignee is a distributor, they are to forward the notification to their customers. The correction is to be extended to the end user/customer level; (2) Determine the current inventory of the affected items and comply with the following instructions: (a) Use the products identified for clamping of tissue and small vessels only; (b) Inspect the products for end-of-life indicators prior to use; (c) Visually inspect the products which should be clean and free of any signs of corrosion and cracks. Check the joint and jaw in the open position from both sides (if needed, use magnification; (d) Test the function of the device, including the jaw area, for deformation and loss of tension. An Acknowledgment Form was enclosed for completion and return via FAX or email within 2 weeks of receipt, even if the total inventory in the consignee location is 0.

Recall details

Recall number
Z-1309-2025
Recall class
Class II
Status
Open, Classified
Initiated by the company
Jan 31, 2025
Posted by the FDA
Mar 11, 2025
Recalling firm
Aesculap Inc
Quantity
917,965 forceps
Product code
HRQ
Distribution
Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.

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

Code information (models, lots, serial numbers)

Show the full code information (4k characters)

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.

Devices named in this recall

119 devices in the FDA device registry whose identifier appears in the recall's code information; the 100 most reported are shown.

Other products in the same recall event

The FDA groups related products into one recall event (event 96223).

Sources and updates

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