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Grasping forceps
SOPRO-COMEG GmbH · Model 394 530 035 · UDI-DI 04059082024905
1
510(k) clearances
83,413
Adverse events (262 deaths)
274
Recalls
572
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-07 | Olympus Corporation of the Americas | Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities. |
| 2025-12-11 | Applied Medical Resources Corp | There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing. |
| 2025-09-24 | Aesculap Inc | It was determined there is the potential of silicone fragments detaching from the yellow sealing component. |
| 2025-09-24 | Aesculap Inc | It was determined there is the potential of silicone fragments detaching from the yellow sealing component. |
| 2025-09-24 | Aesculap Inc | It was determined there is the potential of silicone fragments detaching from the yellow sealing component. |
| 2025-09-24 | Aesculap Inc | It was determined there is the potential of silicone fragments detaching from the yellow sealing component. |
| 2025-06-18 | Stryker Corporation | Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction. |
| 2024-06-25 | UNIMAX MEDICAL SYSTEMS INC | The tube may fall into the surgical site during the grasping process. |
| 2024-06-11 | Canadian Hospital Specialties Ltd. | A customer found product with incomplete seals of P/N 20400161S, lot #185198 which can lead to non-sterile product and patient safety concerns. CHS has validated this complaint. |
| 2024-06-03 | ASPEN SURGICAL | The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.