Wrap, Sterilization
FDA adverse event reports and recall history for wrap, sterilization (product code FRG), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 218
- Deaths
- 0
- Injuries
- 49
- Malfunctions
- 155
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
- 2023-01-30Open, ClassifiedDevice Design
Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
- 2023-01-30Open, ClassifiedDevice Design
Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
- 2022-08-04TerminatedProcess control
Turbett Surgical Container, TS1500
Devices were subject to unapproved rework processes.
- 2022-05-18Open, ClassifiedDevice Design
Turbett Surgical Container, TS1500
Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.
- 2015-03-23TerminatedUnder Investigation by firm
Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425
Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because they were shipped to customers after its expiration date of May 18, 2013.
- 2013-12-03TerminatedDevice Design
STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high, product code: 13906. The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation of contents.
Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not have consistent data to show that sterility assurance level of 10(-6) is achieved during the half-cycle test runs on new, unprocessed containers.
- 2013-03-26TerminatedComponent design/selection
KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider.
Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.
- TerminatedComponent change control
Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch.
- TerminatedComponent change control
Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch.
- TerminatedComponent change control
Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch.
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