Indicator, Physical/Chemical Sterilization Process

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2024-01-26Open, ClassifiedLabeling False and Misleading

  Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron (PCD26-C) Terragene Bionova PCD (PCD222-C)

  Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.

• 2023-05-18Open, ClassifiedProcess control

  3M Attest Steam Chemical Integrators, REF 1243A

  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 sterilization cycle.

• 2023-05-18Open, ClassifiedProcess control

  3M Attest Steam Chemical Integrators, REF 1243B

  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 sterilization cycle.

• 2022-09-26Open, ClassifiedEnvironmental control

  a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator Strip Steam 4 Inch Model Number: SIS-250. b. SPS MEDICAL SUPPLY SteamPlus Sterilization Integrator Sterilization Steam Plus Monitor Model Number: SSI-1000.

  Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

• 2022-09-26Open, ClassifiedEnvironmental control

  a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M Attest INDICATOR, CHEMICAL VAPORIZEDHYDROGEN PEROXIDE (250/BG) Model Number: 1348.

  Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

• 2014-03-10TerminatedLabeling False and Misleading

  VERIFY SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270F using typical healthcare dynamic air removal steam sterilization cycles.

  STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY SixCess Challenge Packs incorrectly identifies the lot as Lot #024522A.

• 2013-07-29TerminatedNonconforming Material/Component

  Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132C (270F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome

  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) because the readout time is not in specification with the label claims.

• 2013-07-29TerminatedNonconforming Material/Component

  Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132C (270F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome.

  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) because the readout time is not in specification with the label claims.

• 2011-08-22TerminatedLabeling False and Misleading

  Verify SixCess Indicator Strips, Model #: PCC005, PCC006, PCC007, PCC008, PCC031, PCC033, PCC034, PCC037 & PCC038, Mfr. By: Albert Browne, LTD, Chancery House 190 Waterside Rd. Hamilton Industrial Park, Leicester, Leicester, LE5QZ, United Kingdom. Verify SixCess Indicator Strips are used to confirm that the parameters of sterilization have been reached within packs, pouches and wrapped items processed through a steam sterilization process. Each indicator strip is specific to a sterilization temperature and type (i.e. 250F 30 minute Gravity Cycle).

  During an inspection the firm was notified that language contained in labeling and promotional literature directs Customers that the products can be used to replace biological indicators and/or release loads containing implants.

• 2011-08-22TerminatedLabeling False and Misleading

  Verify SixCess Challenge Pack, Model #'s: LCC003, LCC005, LCC014 & LCC310, Mfr. By: Albert Browne, LTD, Chancery House 190 Waterside Rd. Hamilton Industrial Park, Leicester, Leicester, LE5QZ, United Kingdom. Verify SixCess Challenge Packs are used to confirm that that critical parameters of steam sterilization have been reached within a challenging test pack design. Each challenge pack is also specific to a sterilization temperature and type (i.e. 275F 3 minute Prevacuum Cycle).

  During an inspection the firm was notified that language contained in labeling and promotional literature directs Customers that the products can be used to replace biological indicators and/or release loads containing implants.