Severity
Moderate
FDA Devices recall · Reported March 19, 2025
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Aesculap Inc recalled Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps … - a moderate-severity action.
Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps … was recalled by Aesculap Inc in March 19, 2025. Reason: The forceps have been used in ways not covered by the design resulting in breakage of the clamps.. Check the official notice for the remedy. Verify recall #Z-1309-2025 with the FDA Devices before acting.
The recall
Aesculap Inc issued this moderate-severity FDA Devices recall-The forceps have been used in ways not covered by the design resulting in breakage of the clamps..
Sourced from official FDA Devices enforcement records. Verify recall #Z-1309-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1309-2025) was formally reported on March 19, 2025, with the manufacturer initiating the action on January 31, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Aesculap Inc is listed as the recalling firm, operating out of Center Valley, PA. Federal records list the affected scope as 917,965 forceps.
The documented reason for this recall is: The forceps have been used in ways not covered by the design resulting in breakage of the clamps. Distribution data in the federal record shows the product reached: Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
917,965 forceps
Related Recalls
6
3 from same agency
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
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1309-2025 |
| Date reported | March 19, 2025 |
| Date initiated | January 31, 2025 |
| Recalling firm | Aesculap Inc |
| Firm location | Center Valley, PA |
| Affected scope | 917,965 forceps |
| Distribution | Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
· 2026-07-02
· 2026-06-25
· 2026-06-18
GE Medical Systems Information Technologies Inc · 2026-06-03
Medline Industries, LP · 2026-06-03
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 19, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.