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Sterilant, Medical Devices
FDA product code MED · Class 2 · General Hospital
477
Registered devices
1,870
Adverse events
21
Recalls
64
510(k) clearances
Devices with this code
Bimanual I/A Systems — STERIMEDIX LIMITEDNA — STERIS CORPORATIONNA — STERIS CORPORATIONSPOROX® II — Sultan Healthcare IncNA — STERIS CORPORATIONFormed Irrigating Cystotomes — STERIMEDIX LIMITEDMcKesson — MCKESSON MEDICAL-SURGICAL INC.Anaesthetic Needles — STERIMEDIX LIMITEDPeracidin® — Angelini Pharma Inc.Hydrodissection Cannulae — STERIMEDIX LIMITEDMaxicide 28 day — HENRY SCHEIN, INC.Rapicide High Level Disinfectant and Sterilant — MEDIVATORS INC.NA — STERIS CORPORATIONNA — STERIS CORPORATIONIrrigation/Aspiration Cannulae — STERIMEDIX LIMITEDNA — STERIS CORPORATIONVitreoretinal Cannulae — STERIMEDIX LIMITEDAEROZYME™ XTRA — ADVANCED STERILIZATION PRODUCTS SERVICES INC.Hydrodissection Cannulae — STERIMEDIX LIMITEDNA — STERIS CORPORATIONNA — STERIS CORPORATIONAnterior Chamber Maintenance Cannulae — STERIMEDIX LIMITEDBackflush Aspiration Handpieces — STERIMEDIX LIMITEDWash Out Cannulae — STERIMEDIX LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2018-07-13 | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical | Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes. |
| 2016-08-02 | Best Sanitizers Inc | Certain lots of the acid solution in Acecide-C are degrading faster than normal. |
| 2015-12-04 | Steris Corporation | The firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port rather than two inlet ports as |
| 2015-08-10 | Advanced Sterilization Products | Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the warnings and rinsing procedure in their current labelling arou |
| 2015-07-27 | Advanced Sterilization Products | Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24-month |
| 2013-03-04 | Steris Corporation | During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be updated to reflect the removal of obsolete device models. This la |
| 2012-08-10 | Steris Corporation | STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices |
| 2012-08-01 | Steris Corporation | The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconne |
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