🏥 Medical Devices Class I - Dangerous
Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported.
All Recalls
95,114 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
St Jude Medical Cardiac Rhythm Management Division
🏥 Medical Devices Class I - Dangerous
Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assura, and Quadra Assura ICDs and Assurity and Allure Pacemakers.
Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
Ziemer Usa
🏥 Medical Devices Class I - Dangerous
The devices were not shipped with the Starter Kits.
🏥 Medical Devices Class I - Dangerous
Incorrect lumi firmware version installed (E.027 instead of V2.00)
🏥 Medical Devices Class I - Dangerous
Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion of another valve, resulting in a Valve in Valve (ViV) implantation. If this occurs, the first valve could embolize and it may be necessary to convert the patient to surgery.
🏥 Medical Devices Class I - Dangerous
During an investigation of instrument logs it was determined that In specific circumstances involving multiple steps, a rack sequencing error may occur. This will result in a mismatch between the sample ID and the test result reported for all subsequent sample racks in that run.
🏥 Medical Devices Class I - Dangerous
Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion of another valve, resulting in a Valve in Valve (ViV) implantation. If this occurs, the first valve could embolize and it may be necessary to convert the patient to surgery.
🏥 Medical Devices Class I - Dangerous
Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of this lead in may prevent or make assembly of the insert and tray difficult.
🏥 Medical Devices Class I - Dangerous
The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve shaft.
🏥 Medical Devices Class I - Dangerous
The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock.
Use of any unauthorized third-party components on Siemens LINACs may lead to patient or operator injury, damage to the LINAC, and can potentially compromise customer warranty. The dark current dose must be considered in the overall dose calculation, or an overdose and serious injury may occur.
🏥 Medical Devices Class I - Dangerous
A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Lentus in the contact lenses, product is not sterile. I Color Color Complete brand color contact lenses are unapproved medical devices.
🏥 Medical Devices Class I - Dangerous
iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.
🏥 Medical Devices Class I - Dangerous
Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment.
🏥 Medical Devices Class I - Dangerous
Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion of another valve, resulting in a Valve in Valve (ViV) implantation. If this occurs, the first valve could embolize and it may be necessary to convert the patient to surgery.
POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
Medtronic Sofamor Danek USA
🏥 Medical Devices Class I - Dangerous
The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.
Mean Green® Super Strength Cleaner & Degreaser and Mean Green® Industrial Strength Cleaner & Degreaser
CR Brands, Inc., West Chester, OH
🏠 Consumer Products Class II - Moderate
The products are labeled "Does not contain Ammonia." The products may contain ammonia. The mislabeling of the bottles can pose a chemical hazard to consumers. If ammonia is mixed with bleach or other household chemicals, irritating or toxic gases could be produced.
La-Z-Boy Control Wands sold with Silver Luxury Lift Chairs
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The wand that controls the chair's movements can overheat, posing a burn hazard.
🍎 Food Class I - Dangerous
Product contains higher than recommended levels of sulfamethazine.