FDA (Devices) recall action 94765
The FDA (Devices) publishes a recall like this one as 39 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 39 pages.
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
American Contract Systems Inc is recalling 107 units of FOOT ANKLE-LF Procedure tray distributed nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits for permanent-implant devices.
American Contract Systems Inc is recalling 272 units of its TOTAL KNEE prosthesis nationwide due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component that exceed safe limits for permanent implants.
American Contract Systems is recalling MAJOR KNEE surgical procedure trays due to excessive ethylene oxide and ethylene chlorohydrin residuals from sterilization that exceed safety limits for permanent exposure devices.
American Contract Systems is recalling TOTAL KNEE procedure trays (Catalog BFTK01Z, lot 983241) due to ethylene oxide and ethylene chlorohydrin residuals exceeding regulatory limits for permanent-use medical devices.
American Contract Systems Inc is recalling 26 TOTAL KNEE Procedure Kits due to excess ethylene oxide and ethylene chlorohydrin residues on the cast padding component that exceed safe exposure limits.
American Contract Systems is recalling TOTAL KNEE procedure trays (Catalog Number BFTK01AA) due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component that exceed acceptable regulatory limits.
American Contract Systems Inc is recalling the BPKN15C Knee Basin Pack procedure tray because sterilant residues (ethylene oxide and ethylene chlorohydrin) exceed safe limits for permanent-use medical devices.
American Contract Systems Inc. is recalling 192 units of cast padding due to excessive ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for skin-contact medical devices.
American Contract Systems Inc is recalling ACL cast padding components due to ethylene oxide/ethylene chlorohydrin residuals exceeding safe limits for permanent skin contact devices. Affected product distributed nationwide.
American Contract Systems Inc is recalling 272 units of the ARTHROSCOPY SUP JOI PACK Procedure Tray because sterilant residuals in the cast padding exceeded safe limits for permanent implant use.
American Contract Systems Inc recalls 174 units of CUSTOM KNEE procedure kits due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe exposure limits for permanent contact devices.
American Contract Systems Inc is recalling the ACL PACK Surgical Procedure Kit due to elevated ethylene oxide and ethylene chlorohydrin residuals that exceed regulatory limits for permanent-contact medical devices.
American Contract Systems Inc is recalling 27 arthroscopy procedure kits because ethylene oxide and ethylene chlorohydrin residuals in the cast padding exceeded safe exposure limits for permanent implants.
American Contract Systems is recalling 27 arthroscopy procedure kits because the cast padding component contains ethylene oxide and ethylene chlorohydrin residues exceeding safe limits for permanent exposure devices.
American Contract Systems Inc is recalling 36 units of Hand Pack procedure kits due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component exceeding regulatory limits.
American Contract Systems recalls the ARTHROSCOPY WOLFSON PACK BHS Procedure tray because ethylene oxide residuals on the cast padding exceeded safety limits for permanent exposure medical devices.
American Contract Systems Inc is recalling the Hand Draping SJH-Procedure Kit because residual levels of ethylene oxide and ethylene chlorohydrin exceeded safe limits for permanent-contact medical devices.
American Contract Systems Inc is recalling TOTAL KNEE-Procedure Kits due to excessive ethylene oxide and ethylene chlorohydrin residues on the cast padding component. The recall affects 85 units distributed nationwide.
American Contract Systems recalls HAND PACK-Procedure Kits due to excess ethylene oxide and ethylene chlorohydrin residuals on the cast padding component, exceeding safe permanent-contact exposure limits.
American Contract Systems is recalling TOTAL KNEE procedure trays because sterilization gas residuals on the cast padding component exceed regulatory safety limits. No injuries have been reported.
American Contract Systems Inc recalls the TOTAL KNEE Procedure Kit due to Ethylene Oxide and Ethylene Chlorohydrin residuals exceeding regulatory limits. No illnesses reported.
American Contract Systems Inc. is recalling KNEE SCOPE Procedure Tray kits because ethylene oxide sterilization residues in the cast padding component exceed safe exposure limits per FDA and ISO standards.
American Contract Systems Inc. is recalling 84 knee arthroscopy packs (Catalog Number MEKA12R) distributed nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for permanent exposure medical devices.
American Contract Systems Inc is recalling 36 units of its knee arthroscopy procedure kit due to excessive sterilization chemical residues in the cast padding component that exceed safe exposure limits.
American Contract Systems Inc recalled a knee surgery procedure kit (Catalog RGTK10K) due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits on the cast padding component.