💊 Drugs Class I - Dangerous
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
All Recalls
95,114 total recalls in our database
💊 Drugs Class I - Dangerous
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
💊 Drugs Class I - Dangerous
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
Boston Scientific
🏥 Medical Devices Class I - Dangerous
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.
Augustine Temperature Management
🏥 Medical Devices Class I - Dangerous
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
Intuitive Surgical
🏥 Medical Devices Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
🏥 Medical Devices Class I - Dangerous
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
8MM,MEGA SUTURECUT ND,IS4000 REF 471309
Intuitive Surgical
🏥 Medical Devices Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Reports of various packaging issues that may result in a breach of the sterile barrier.
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
Intuitive Surgical
🏥 Medical Devices Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
8MM,PROGRASP FORCEPS,IS4000 REF 471093
Intuitive Surgical
🏥 Medical Devices Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
🏥 Medical Devices Class I - Dangerous
Reports of various packaging issues that may result in a breach of the sterile barrier.
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.
🏥 Medical Devices Class I - Dangerous
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Hologic
🏥 Medical Devices Class I - Dangerous
Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.
Augustine Temperature Management
🏥 Medical Devices Class I - Dangerous
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
SIN SISTEMA DE IMPLANTE NACIONAL S.A
🏥 Medical Devices Class I - Dangerous
Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the larger diameter stated on the box, the smaller diameter implant, will become loose and will not fit, which may necessitate an additional surgery.
ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical
Sklar Instruments
🏥 Medical Devices Class I - Dangerous
Reports of various packaging issues that may result in a breach of the sterile barrier.