American Contract Systems Inc
161 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for American Contract Systems Inc and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-08-14FDA-DeviceClass IIAmerican Contract Systems Hand Pack convenience kit
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
- 2024-07-17FDA-DeviceClass IIKNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: WEKA15B
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.
- 2024-07-17FDA-DeviceClass IIHAND PACK-Procedure Kit Catalog Number: WEHD16C
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.
- 2024-07-17FDA-DeviceClass IIHAND PACK-Procedure Kit Catalog Number: WEHD16B
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.
- 2024-07-17FDA-DeviceClass IIORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44S
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.
- 2024-07-17FDA-DeviceClass IICUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG
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.
- 2024-07-17FDA-DeviceClass IICUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AE
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.
- 2024-07-17FDA-DeviceClass IIACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA
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.
- 2024-07-17FDA-DeviceClass IITPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E
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.
- 2024-07-17FDA-DeviceClass IIARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22V
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.
- 2024-07-17FDA-DeviceClass IIARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22U
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.
- 2024-07-17FDA-DeviceClass IITOTAL KNEE-Procedure Kit Catalog Number: SMTK21C
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.
- 2024-07-17FDA-DeviceClass IIKNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14G
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.
- 2024-07-17FDA-DeviceClass IIHAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67F
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.
- 2024-07-17FDA-DeviceClass IITOTAL KNEE-Procedure Kit Catalog Number: SFTK54B
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.
- 2024-07-17FDA-DeviceClass IIKNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60A
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.
- 2024-07-17FDA-DeviceClass IITOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L
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.
- 2024-07-17FDA-DeviceClass IITOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10K
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.
- 2024-07-17FDA-DeviceClass IIHAND PACK 297829--Procedure Kit Catalog Number: RGHN04I
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.
- 2024-07-17FDA-DeviceClass IITOTAL KNEE -Procedure Kit Catalog Number: QPTK95B
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.
- 2024-07-17FDA-DeviceClass IITOTAL KNEE -Procedure Kit Catalog Number: QPTK95A
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.
- 2024-07-17FDA-DeviceClass IIKNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35A
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.
- 2024-07-17FDA-DeviceClass IIKNEE ARTHROSCOPY PACK Catalog Number: MEKA12R
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.
- 2024-07-17FDA-DeviceClass IITOTAL KNEE, ST LUKES Catalog Number: LMTK17AP
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.
- 2024-07-17FDA-DeviceClass IIACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA
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.
- 2024-07-17FDA-DeviceClass IIUPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AG
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.
- 2024-07-17FDA-DeviceClass IIKNEE SCOPE Procedure tray Catalog Number: COKN48L
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.
- 2024-07-17FDA-DeviceClass IIHAND WRIST FOREARM-LF Procedure tray Catalog Number: CCHD17B
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.
- 2024-07-17FDA-DeviceClass IIFOOT ANKLE-LF Procedure tray Catalog Number:CCFA51B
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.
- 2024-07-17FDA-DeviceClass IIBPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C
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.
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