Medical device recalls
39048 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2024-07-17FDA-DeviceBaxter Healthcare CorporationClass IIVidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c) 4028310 (Ceiling Trio Surgical Lights)
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads
- 2024-07-17FDA-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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-DeviceAmerican Contract Systems IncClass 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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