Medical Device Recalls
RSS ↗7,979 medical device recalls from federal enforcement feeds.
Showing 7,601–7,650 of 7,979
- Class I
Medical Device Recall · December 4, 2023
Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HConvenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- Class I
Medical Device Recall · December 4, 2023
Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover"Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- Class I
Medical Device Recall · December 4, 2023
Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 16FR (5.3 MM), 5CC,Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- Class II
Medical Device Recall · December 4, 2023
Model No. CYF-5R, CystonephrofiberscopeOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- Class II
Medical Device Recall · December 1, 2023
SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a coronary artery bypass graft (CABG) or peripheral bypass graft surgery.
- Class II
Medical Device Recall · December 1, 2023
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a coronary artery bypass graft (CABG) or peripheral bypass graft surgery.
- Class II
Medical Device Recall · December 1, 2023
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32JProduct manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number: 73-0510Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-2910Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-0910Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement Product Number: 6637-4-231Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-831Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32JProduct manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
Olympus Corporation of the Americas
SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BSOlympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to break during use, which may cause burns, procedure delays, prolonged surgery, and foreign body in patient.
- Class II
Medical Device Recall · December 1, 2023
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-2710Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-0710Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Class II
Medical Device Recall · December 1, 2023
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.