The Recall Desk
HighFDA (Devices)·Z-1308-2025·Announced 2025-03-19

Hemostatic Forceps Recalled Due to Clamp Breakage in Surgical Use

Aesculap Inc is recalling 19,979 hemostatic forceps across 18 models because clamps can break when instruments are used outside of design specifications.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall affecting surgical instruments where clamps break when used outside design specifications. This manifested hazard during surgical procedures meets the criteria for High severity.

Plain-English summary

Aesculap Inc has recalled 19,979 nonsterile hemostatic forceps across 18 models, including Phaneuf, Heaney, Holzbach, Wertheim, and other hysterectomy and parametrium clamp designs. The recalled forceps carry reference numbers from BJ500R through MD592 and have been distributed nationwide, to Puerto Rico, and internationally to Canada, Bermuda, Bahamas, and Qatar. The company also distributed these forceps to government and military facilities.

The forceps have been used in ways not covered by their design specifications, resulting in breakage of the clamps. When surgical instruments fail during use, they can compromise the safety and effectiveness of the procedure.

Healthcare facilities and medical professionals using these forceps should discontinue use immediately. Contact Aesculap Inc for guidance on returns, replacements, or further instructions regarding the affected models.

The recalled product

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 BJ52
Manufacturer
Aesculap Inc
Category
Medical Device
Hazard
  • clamp-breakage
  • instrument-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (18)

  • 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.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category