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Novo Surgical Inc.
NOVO SURGICAL, INC. · Model 9122-01 · UDI-DI 00842331189920
MDM
Prescription
10
510(k) clearances
4,185
Adverse events (4 deaths)
77
Recalls
847
Facilities
Description
flat caps, gas or steam permeable, can be used in flash or conventional autoclave processes, latex-free, 100 per package, 3/8" x 1" x 2mm, clear
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-07 | Healthmark Industries Co., Inc. | Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated. |
| 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. |
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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.