Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
All Recalls
95,018 total recalls in our database
KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Microbiologics
🏥 Medical Devices Class I - Dangerous
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
🏥 Medical Devices Class I - Dangerous
Safety and efficacy of dialysis acid concentrate cannot be assured
🏥 Medical Devices Class I - Dangerous
Safety and efficacy of dialysis acid concentrate cannot be assured
🏥 Medical Devices Class I - Dangerous
Safety and efficacy of dialysis acid concentrate cannot be assured
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Intuitive Surgical
🏥 Medical Devices Class I - Dangerous
Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure
🏥 Medical Devices Class I - Dangerous
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
🏥 Medical Devices Class I - Dangerous
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
🏥 Medical Devices Class I - Dangerous
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
🏥 Medical Devices Class I - Dangerous
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
🏥 Medical Devices Class I - Dangerous
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
🏥 Medical Devices Class I - Dangerous
Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.
🏥 Medical Devices Class I - Dangerous
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
AGFA Healthcare
🏥 Medical Devices Class I - Dangerous
It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.
KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
Microbiologics
🏥 Medical Devices Class I - Dangerous
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Microbiologics
🏥 Medical Devices Class I - Dangerous
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
🏥 Medical Devices Class I - Dangerous
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
🏥 Medical Devices Class I - Dangerous
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
17 Stories Furniture 18-Drawer Dressers
Jiangsu Quanronghe Smart Home Co., Ltd., of China
🏠 Consumer Products Class I - Dangerous
The recalled dressers are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazard that can result in injuries or death to children. The dressers violate the mandatory standard as required by the STURDY Act.
AMP MP2 Smart Fitness Machine
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The arm on the MP2 model of the fitness machine does not lock properly, which can allow the arm to swing unexpectedly, posing a risk of laceration or serious injury.