ATRAUMATA recallZ-1311-2025 · Aesculap Inc · initiated Jan 31, 2025
Open, Classified
Is my device affected?
- 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.
- 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.
- 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-1311-2025
- Status
- Open, Classified
- Initiated by the company
- Jan 31, 2025
- Posted by the FDA
- Mar 11, 2025
- Recalling firm
- Aesculap Inc
- Quantity
- 1,147 forceps
- Product code
- HXD
- 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 FB458R, Glover ATR.CLAMP CVD 215MM; (2) REF FB459R, Glover ATR.CLAMP CVD 245MM; (3) REF FB461R, Glover ATR.CLAMP 195MM; (4) REF FB462R, Glover ATR.CLAMP 210MM; (5) REF FB469R, Leland-Jones Peripheral CLMPSTR 195MM; (6) REF FB567R, Cooley Pediatric Clamp 30DG30/165MM; (7) REF FB568R, Cooley Pediatric Clamp 60DG 30/160MM; (8) REF FB569R, Cooley Pediatric Clamp 90DG30/150MM; (9) REF FB729R, Cooley Pediatric Clamp 17MM 170MM; (10) REF FB730R, Cooley Pediatric Clamp 20MM175MM; (11) REF FB736R, Cooley Pediatric Clamp 74MM 185MM; (12) REF FB737R, Cooley Pediatric Clamp 86MM 195MM; and (13) REF FB738R, Cooley Pediatric Clamp 108MM 260MM.
Code information (models, lots, serial numbers)
GTIN numbers: (1) REF FB458R - 04038653156078; (2) REF FB459R - 04038653156085; (3) REF FB461R - 04038653156108; (4) REF FB462R - 04038653156115; (5) REF FB469R - 04038653156184; (6) REF FB567R - 04038653156948; (7) REF FB568R - 04038653156955; (8) REF FB569R - 04038653156962; (9) REF FB729R - 04038653157617; (10) REF FB730R - 04038653157624; (11) REF FB736R - 04038653157686; (12) REF FB737R - 04038653157693; and (13) REF FB738R - 04038653157709.
Devices named in this recall
13 devices in the FDA device registry whose identifier appears in the recall's code information.
- ATRAUMATA FB458RAesculap AG · CLAMP1 recall0 reports
- ATRAUMATA FB459RAesculap AG · CLAMP1 recall0 reports
- ATRAUMATA FB461RAesculap AG · CLAMP1 recall0 reports
- ATRAUMATA FB462RAesculap AG · CLAMP1 recall0 reports
- ATRAUMATA FB469RAesculap AG · CLAMP1 recall0 reports
- ATRAUMATA FB567RAesculap AG · CLAMP1 recall0 reports
- ATRAUMATA FB568RAesculap AG · CLAMP1 recall0 reports
- ATRAUMATA FB569RAesculap AG · CLAMP1 recall0 reports
- ATRAUMATA FB729RAesculap AG · CLAMP1 recall0 reports
- ATRAUMATA FB730RAesculap AG · CLAMP1 recall0 reports
- ATRAUMATA FB736RAesculap AG · CLAMP1 recall0 reports
- ATRAUMATA FB737RAesculap AG · CLAMP1 recall0 reports
- ATRAUMATA FB738RAesculap AG · CLAMP1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 96223).
- Z-1308-2025 · Open, ClassifiedNumerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ501R, Phaneuf Hysterectomy Forceps ANG 205MM; (3) REF BJ511R, H…
- Z-1309-2025 · Open, ClassifiedNumerous 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 …
- Z-1310-2025 · Open, ClassifiedNumerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig Artery Forceps CVD.190MM; (2) REF BH304R, Pean Artery Forceps Straight 140MM; (3) REF BH813R, Artery Forc…
- Z-1312-2025 · Open, ClassifiedNumerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R, Negus Tonsil Forceps X-HVY-CVD190MM; (3) REF BH957R, Schnidt …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page