Home › Device types › JOJ
Indicator, Physical/Chemical Sterilization Process
FDA product code JOJ · Class 2 · General Hospital
893
Registered devices
386
Adverse events
24
Recalls
264
510(k) clearances
Devices with this code
Plastcare — Plastcare USAVERIFY — ALBERT BROWNE LIMITEDMedline — MEDLINE INDUSTRIES, INC.SAFE DENT — BGSS Company Inc.Sklar® — SKLAR CORPORATIONCintape® — TERRAGENE S.A.NA — STERIS CORPORATIONMARK3 — CARGUS INTERNATIONAL, INCVERIFY — ALBERT BROWNE LIMITEDGetinge Assure Green Tape 1 IN — STERITEC PRODUCT MFG. CO., INC.Bionova® — TERRAGENE S.A.Getinge Pack Sterilization Roll — PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETIPropper Verline Indicator Tape — PROPPER MANUFACTURING COMPANY, INC.BENCO — BENCO DENTAL SUPPLY CO.Serim® GUARDIAN™ Peracetic Acid Test Strips — SERIM RESEARCH CORPORATIONBionova® — TERRAGENE S.A.Steam Autoclave Tape — MESA LABORATORIES, INC.STEAMPLUS STERILIZATION INTEGRATOR — CROSSTEX INTERNATIONAL, INC.SteriScan — STERIS CORPORATIONMARK3 — CARGUS INTERNATIONAL, INCVERIFY — ALBERT BROWNE LIMITEDTuttnauer® — TERRAGENE S.A.MARK3 — CARGUS INTERNATIONAL, INCOnce-A-Day Bowie & Dick Test Sheets — PROPPER MANUFACTURING COMPANY, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-07 | TERRAGENE S.A. | Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products. |
| 2023-04-06 | 3M Company - Health Care Business | 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a st |
| 2023-04-06 | 3M Company - Health Care Business | 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a st |
| 2022-08-10 | Steris Corporation Hopkins Facility | Product contains incorrect chemical indicators in packaging. |
| 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 |
| 2021-12-29 | Young Dental Mfg Co I LLC | The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels. |
| 2020-06-17 | Resource Optimization & Innovation LLC | The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the "accept" window at the time of use. |
| 2013-12-19 | Steris Corporation | STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY SixCess Challenge Packs incorrectly identifies the lot as Lot #024522 |
| 2013-06-10 | Steritec Products Mfc. Co., Inc. | Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) b |
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