Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 33201–33220 of 38,428 recalls
Recalled Item: Universal Pack II (2) Customed 900-2509 (1) MAYO STAND COVER
The Issue: Customed has determined that there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PREMIUM ARTHROSCOPY PACK - CUSTOMED- (1) ARTHROSCOPY SHEET T WITH
The Issue: Customed has determined that there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HIGADO & PANCREA PACK - (1) BAG SUTURE FLORAL (2)
The Issue: Customed has determined that there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LAPAROSCOPY~OBPACK - (4) ABSORBENT TOWELS 15" x 20" LIF (2)
The Issue: Customed has determined that there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PLASTIC SURGERY PACK- (1) MAYO STAND COVER REINFORCED LIF (1)
The Issue: Customed has determined that there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEURO PACK - (1) CAUTERY TIP POLISHER LIF (4) DRAPE
The Issue: Customed has determined that there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gown Cool Impervious XLGE Breathable Customed
The Issue: Customed has determined that there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPLANTE DE ORTHOPEDIA- 1) GOWN IMPERV. XTRA REINF. XL SMS
The Issue: Customed has determined that there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CATARACT PACK- OJOS INC.- (1) TABLE COVER REINF. 44" X
The Issue: Customed has determined that there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gown Surgical Soft SMS Non Reinforced
The Issue: Customed has determined that there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 0.B. PACK - HSCH- (1) PVP SCRUB 8" STICK SPONGES
The Issue: Customed has determined that there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: REYITO UROLOGY PACK - (2) GOWN IMP. REINFORCED X-LARGE SMS
The Issue: Customed has determined that there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LAPAROTOMY PACK - (I) SURGICAL BLADE #10 S/STEEL ( I)
The Issue: Customed has determined that there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Breast Pack MRT
The Issue: Customed has determined that there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C - BIRTH PACK II {2) CUSTOMED CONTENT: (1) GOWN
The Issue: Customed has determined that there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SHOULDER ARTHROSCOPY PACK CONTENTS: (1) SUTURE BAG FLORAL (1) UTILITY
The Issue: Customed has determined that there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANGIOGRAPHY PACK - (1) LINE H.P. 1200 PSI 48" M/F
The Issue: Customed has determined that there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Customed Major Laparotomy Pack
The Issue: Customed has determined that there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRAATEK NEURO PACK (4)TOWEL ABSORBENT 15" X 20" LIF (
The Issue: Customed has determined that there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bandeja para Debridacion
The Issue: Customed has determined that there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.