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Karl Storz GmbH & Co. KG · Model 553514 · UDI-DI 04048551003213
LQR
Prescription
10
510(k) clearances
847
Adverse events (5 deaths)
11
Recalls
41
Facilities
Description
Metal Outer Sheath, 3.5 mm, 14 cm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-05 | Cook Incorporated | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 | Cook Incorporated | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2009-01-08 | Boston Scientific Corp | The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to |
| 2009-01-08 | Boston Scientific Corp | The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to |
| 2009-01-08 | Boston Scientific Corp | The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to |
| 2006-05-19 | Boston Scientific Corp | Lack of assurance of sterility, as the sterile barrier may fail. |
| 2006-05-19 | Boston Scientific Corp | Lack of assurance of sterility, as the sterile barrier may fail. |
| 2006-05-19 | Boston Scientific Corp | Lack of assurance of sterility, as the sterile barrier may fail. |
| 2006-05-19 | Boston Scientific Corp | Lack of assurance of sterility, as the sterile barrier may fail. |
| 2006-05-19 | Boston Scientific Corp | Lack of assurance of sterility, as the sterile barrier may fail. |
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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.