🏥 Medical Devices Class I - Dangerous
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
All Recalls
95,018 total recalls in our database
Various neurology packs
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Various Pacemaker Packs, Cardio Thoracic Packs
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
🏥 Medical Devices Class I - Dangerous
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
🏥 Medical Devices Class I - Dangerous
Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissue and increase healing time
Medline CHEST TUBE REORDER NO: DYNJ36762A
Medline Industries
🏥 Medical Devices Class I - Dangerous
Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit
Various ENT Packs
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
Ortho-Clinical Diagnostics
🏥 Medical Devices Class I - Dangerous
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
🏥 Medical Devices Class I - Dangerous
Certain lots containing undersized dilator.
Various Angiography/Cath Lab packs/trays
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Philips Respironics
🏥 Medical Devices Class I - Dangerous
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.
Abbott Molecular
🏥 Medical Devices Class I - Dangerous
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
Various Cysto Packs
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Various hysterectomy, vaginal packs
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
Biosense Webster
🏥 Medical Devices Class I - Dangerous
Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices with a compromised sterile barrier could be a source for infection.
Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Philips Respironics
🏥 Medical Devices Class I - Dangerous
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
🏥 Medical Devices Class I - Dangerous
Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
Various Laparoscopy Packs
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Various PICC Line, Central Line Packs
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
thyssenkrupp Access Corp. Residential Elevators
ThyssenKrupp Access Manufacturing
🏠 Consumer Products Class I - Dangerous
Children can become entrapped in the space between the exterior hoistway door and the elevator car door or gate and suffer serious injury or death if the elevator is called to another floor.