🏥 Medical Devices Class I - Dangerous
Products expire prior to the expiration date printed on the product labeling
All Recalls
95,075 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised.
ENT, COEN27N; Medical convenience kit
American Contract Systems
🏥 Medical Devices Class I - Dangerous
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
🏥 Medical Devices Class I - Dangerous
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
🏥 Medical Devices Class I - Dangerous
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
🏥 Medical Devices Class I - Dangerous
Products expire prior to the expiration date printed on the product labeling
🏥 Medical Devices Class I - Dangerous
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A
CooperSurgical
🏥 Medical Devices Class I - Dangerous
Low concentration of sodium pyruvate in the wash could compromise gamete development
🏥 Medical Devices Class I - Dangerous
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Silver-Plated Copper Sims Uterine Sound, Part Number 64-600
CooperSurgical
🏥 Medical Devices Class I - Dangerous
During the manufacturing process the devices were laser-marked with the incorrect part number.
🏥 Medical Devices Class I - Dangerous
The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
Arthroscopy Pack, MSKA45A; Medical convenience kit
American Contract Systems
🏥 Medical Devices Class I - Dangerous
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
🏥 Medical Devices Class I - Dangerous
GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the product design. However, because the electrical safety testing in manufacturing was incomplete for these devices, there is the potential for leakage current to exceed IEC 60601 limits.
Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123
Karl Storz Endoscopy
🏥 Medical Devices Class I - Dangerous
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
🏥 Medical Devices Class I - Dangerous
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
🏥 Medical Devices Class I - Dangerous
Products expire prior to the expiration date printed on the product labeling
Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and result in misdiagnosis with the possibility being a false negative diagnosis
Open Shoulder, LWOS39L; Medical convenience kit
American Contract Systems
🏥 Medical Devices Class I - Dangerous
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
🏥 Medical Devices Class I - Dangerous
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.