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SoBe®
Stanley Medical Designs, Incorporated · Model 1510-03S · UDI-DI 00850013858101
FZT
Prescription
10
510(k) clearances
609
Adverse events
6
Recalls
255
Facilities
Description
Blue SoBe® Jointed Cutter Package (Contains 1 each of 00850013858026, 00850013858033, 00850013858118)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2010-06-04 | Maquet Cardiovascular | Pouch integrity may be compromised, resulting in loss of sterility. |
| 2008-04-24 | Ethicon Endo-Surgery Inc | The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line. |
| 2008-04-24 | Ethicon Endo-Surgery Inc | The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line. |
| 2008-04-24 | Ethicon Endo-Surgery Inc | The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line. |
| 2008-04-24 | Ethicon Endo-Surgery Inc | The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line. |
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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.