Hemostatic Forceps (Aesculap) – clamp breakage (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ501R, Phaneuf Hysterectomy Forceps ANG 205MM; (3) REF BJ511R, Holzbach Hyst Forceps CVD245MM; (4) REF BJ520R, Heaney Hyst Forceps Grooved 205MM; (5) REF BJ521R, Heaney Hyst Forceps Grooved 250MM; (6) REF BJ522R, Heaney Hyst Forceps Grooved 195MM; (7) REF BJ524R, Heaney-Rezek Fcpsstr Ser Lgth 210MM; (8) REF BJ527R, Wiener Hyst Forceps Grooves 240MM; (9) REF BJ530R, Heaney
Brand
Aesculap Inc
Lot Codes / Batch Numbers
GTIN numbers: (1) REF BJ500R - 04038653139378, (2) REF BJ501R - 04038653139385, (3) REF BJ511R - 04038653139392, (4) REF BJ520R - 04038653139408, (5) REF BJ521R - 04038653139415, (6) REF BJ522R - 04038653139422, (7) REF BJ524R - 04046963364250, (8) REF BJ527R - 04038653139446, (9) REF BJ530R - 04038653139453, (10) REF BJ531R - 04038653139460, (11) REF BJ532R - 04038653139477, (12) REF BJ534R - 04038653027798, (13) REF BJ550R - 04038653139484, (14) REF BJ551R - 04038653139491, (15) REF BJ552R - 04038653139507, (16) REF BJ553R - 04038653139514, (17) REF MD591 - 04046963365592, and (18) REF MD592 - 04046963365608.
Products Sold
GTIN numbers: (1) REF BJ500R - 04038653139378; (2) REF BJ501R - 04038653139385; (3) REF BJ511R - 04038653139392; (4) REF BJ520R - 04038653139408; (5) REF BJ521R - 04038653139415; (6) REF BJ522R - 04038653139422; (7) REF BJ524R - 04046963364250; (8) REF BJ527R - 04038653139446; (9) REF BJ530R - 04038653139453; (10) REF BJ531R - 04038653139460; (11) REF BJ532R - 04038653139477; (12) REF BJ534R - 04038653027798; (13) REF BJ550R - 04038653139484; (14) REF BJ551R - 04038653139491; (15) REF BJ552R - 04038653139507; (16) REF BJ553R - 04038653139514; (17) REF MD591 - 04046963365592; and (18) REF MD592 - 04046963365608.
Aesculap Inc is recalling Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps ST due to The forceps have been used in ways not covered by the design resulting in breakage of the clamps.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026