The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch.
🏥
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Affixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 Product Usage: Intended for the fixation of fractures
Zimmer Biomet
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
Siemens Healthcare Diagnostics
Class I - Dangerous
A potential bias was identified with certain kits compared to the internal standards.
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Affixus Hip Fracture Nail 125 9 mm x 165 mm, Item Number 816709165 Product Usage: Intended for the fixation of fractures
Zimmer Biomet
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number 814409320 Product Usage: Intended for the fixation of fractures
Zimmer Biomet
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Class I - Dangerous
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Colpo-Pneumo Occluder, Part CPO-6
CooperSurgical
Class I - Dangerous
The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
Class I - Dangerous
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.
Orthosensor
Class I - Dangerous
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
Class I - Dangerous
The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) battery drawer on some BABY440 hearing aids. The correct battery drawer is tamper-resistant and require a special tool to open it.
OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.
Orthosensor
Class I - Dangerous
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Class I - Dangerous
Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.
The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage.
When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.
Potential for the tethered plug on the hub of the NeoMed Enteral Feeding Tubes with Enteral Only Connectors to inadvertently open after closure.
Class I - Dangerous
Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life
Class I - Dangerous
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Class I - Dangerous
Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer conducted further testing confirming the dust cap may generate particulate which may potentially enter the fluid path.