🏥 Medical Devices Class I - Dangerous
Products contain international package insert and not the correct USA package insert
All Recalls
95,089 total recalls in our database
🏥 Medical Devices Class I - Dangerous
OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.
SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
Abbott Medical Optics Inc. (AMO)
🏥 Medical Devices Class I - Dangerous
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium.
The Anspach Effort
🏥 Medical Devices Class I - Dangerous
The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503.
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2
Carefusion 2200
🏥 Medical Devices Class I - Dangerous
The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packaged with the 8 cm Berman Oral Airway. The pouch contained within the module is correctly labeled as 5 cm but actually contains an 8 cm Berman Oral Airway component. Therefore, the component within the pouch is incorrect. The PINK/RED Oxygen Delivery Module, 7700RAW, is intended to be used within the PINK/RED Pouch of the BROSELOW pediatric safety system. Three (3) lots (lot# 914873, lot# 914876 and lot #914878) of the PINK/RED Oxygen Delivery Module, 7700RAW, are affected by this voluntary Field Safety Corrective Action.
G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.
The Anspach Effort
🏥 Medical Devices Class I - Dangerous
Product Code L- 7B-G1 was inadvertently released off of hold status and the affected products were distributed.
🏥 Medical Devices Class I - Dangerous
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
🏥 Medical Devices Class I - Dangerous
OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.
🏥 Medical Devices Class I - Dangerous
An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.
FPS 35mm x 3.5 mm non-locking screw
Ortho Solutions
🏥 Medical Devices Class I - Dangerous
Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.
🏥 Medical Devices Class I - Dangerous
Products contain international package insert and not the correct USA package insert
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high.
🏥 Medical Devices Class I - Dangerous
Patient information in the header is only found on the first page of the report and not on the subsequent pages.
🏥 Medical Devices Class I - Dangerous
Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the potential for failure of the Uninterruptible Power Supply.
🏥 Medical Devices Class I - Dangerous
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag
Abbott Medical Optics Inc. (AMO)
🏥 Medical Devices Class I - Dangerous
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
🏥 Medical Devices Class I - Dangerous
Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches, Product Code 7730MOD
Carefusion 2200
🏥 Medical Devices Class I - Dangerous
The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packaged with the 8 cm Berman Oral Airway. The pouch contained within the module is correctly labeled as 5 cm but actually contains an 8 cm Berman Oral Airway component. Therefore, the component within the pouch is incorrect. The PINK/RED Oxygen Delivery Module, 7700RAW, is intended to be used within the PINK/RED Pouch of the BROSELOW pediatric safety system. Three (3) lots (lot# 914873, lot# 914876 and lot #914878) of the PINK/RED Oxygen Delivery Module, 7700RAW, are affected by this voluntary Field Safety Corrective Action.
HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A
Philips Electronics North America
🏥 Medical Devices Class I - Dangerous
The handle can separate from the MRx housing due to breakage of mounts on the rear case.
🏥 Medical Devices Class I - Dangerous
The recalling firm identified ten devices which were distributed and could potentially be non-compliant. These devices potentially underwent a routine manufacturing test with non-compliant parameters, which may result in a small blister in the epoxy over transducers in the treatment zone. It is not known at the time the recall was initiated whether the non-compliant test parameters, or presence of the blisters, adversely affect operation of the device.