Home › RZ-Medizintechnik GmbH › RZ Medizintechnik GmbH
RZ Medizintechnik GmbH
RZ-Medizintechnik GmbH · Model 260-502-185 · UDI-DI 04049197196345
MDM
Prescription
10
510(k) clearances
4,143
Adverse events (4 deaths)
76
Recalls
840
Facilities
Description
SHAPER Sheath f. 5mm Telescopes, rotat. stop cock, large flat angled spatula view during tissue dissection
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-03 | MEDLINE INDUSTRIES, LP - Northfield | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2024-01-31 | Technicality Inc. | The Ring on the Trump Needle Guide can detach when excessive pressure is applied. |
| 2024-01-30 | Applied Medical Resources Corp | Their is the potential that Universal Clip applier may not load clip after the trigger is actuated. |
| 2024-01-30 | Applied Medical Resources Corp | Their is the potential that Universal Clip applier may not load clip after the trigger is actuated. |
| 2022-11-17 | MEDLINE INDUSTRIES, LP - Northfield | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2022-11-08 | ENDO Pharmaceuticals Solutions, Inc. | No expiration dates printed on the packaging |
| 2022-11-02 | Arthrex, Inc. | The devices may be packaged with the wrong reamer size. |
| 2021-12-22 | FlexDex Inc. | The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in th |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.