🏥 Medical Devices Class I - Dangerous
The incorrect dental pins were packaged and subsequently distributed.
All Recalls
95,025 total recalls in our database
DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONLY, UDI: (01)00190446683681 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
DJ Orthopedics de Mexico S.A. de C.V.
🏥 Medical Devices Class I - Dangerous
failed rivet at the chafe tab of arm sling.
🏥 Medical Devices Class I - Dangerous
BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.
🏥 Medical Devices Class I - Dangerous
Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended
🏥 Medical Devices Class I - Dangerous
Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw
Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of up to 10 seconds in displaying ECG, invasive blood pressure and other parameters; patient weight is rounded to the nearest whole kilogram;Xper IM software used with the Xper Flex Cardio Physio Monitoring System may periodically crash; No SpO2 numeric or plethysmography is displayed when SpO2 is connected o the Flex Cardio device; display of certain data from the FC2010 becomes frozen, i.e., waveforms cease sweeping and updating and the ECG, IBP, and respiration numeric values cease to update;e ECG, IBP, and respiration waveforms become flat lines and no audible alarms are produced for HR and IBP, upon start up, an unexpected non physiological ECG waveform, erratic heart rate numeric value, and non-physiological display of any other active waveforms may appear on the Boom Monitor
🏥 Medical Devices Class I - Dangerous
There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).
Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchial tree.
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.
DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
DJ Orthopedics de Mexico S.A. de C.V.
🏥 Medical Devices Class I - Dangerous
failed rivet at the chafe tab of arm sling.
Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product Usage: AXS Universal Aspiration Tubing is used with the Dominant Flex Surgical Suction Pump.
Medela AG Medical Technology
🏥 Medical Devices Class I - Dangerous
Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".
DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
DJ Orthopedics de Mexico S.A. de C.V.
🏥 Medical Devices Class I - Dangerous
failed rivet at the chafe tab of arm sling.
Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
Potentially defective component in the AC power adapter which may fail over time.
Omnia SRL received a notification from the contract manufacturer informing them of inadequate sterilization processes which have been taking place at their contracted sterilizing facility since 2016.
🏥 Medical Devices Class I - Dangerous
Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting
🏥 Medical Devices Class I - Dangerous
Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.
Inclined sleeper accessory included with Kolcraft Cuddle 'n Care 2-in-1 Bassinet & Incline Sleepers and Preferred Position 2-in-1 Bassinet & Incline Sleepers
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
Infant fatalities have been reported with other manufacturers' inclined sleep products, after the infants rolled from their back to their stomach or side, or under other circumstances.
Tread
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The touchscreen on the treadmill can detach and fall, posing a risk of injury to consumers.
Tread+
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
Adult users, children, pets and objects can be pulled underneath the rear of the treadmill, posing a risk of injury or death.
WAYNE WaterBUG GLOW Multi-Use Submersible Water Removal Pumps
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
If water gets into the electrical circuit board, it can short circuit, posing fire, burn and electrical shock hazards.
Pickens Flip Up Towel Grab Bars
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The product can break, if the towel bar is used to provide bodily support, posing fall and injury hazards.