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Last updated: June 2022
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Displaying 1 - 15 of 50 items.
NCB Screw 5.0 L=38
Zimmer GmbH is conducting a medical device field safety corrective action (removal) for one lot of the NCB femoral screws. The product in scope is part of a mix-up with a NCB humeral screw that differs in dimensions and therefore it has been decided to…
RecallHealth product recall | 2022-06-27
Merlin Patient Care System - Programmer Software
Abbott is notifying customers of the potential for programmer software (Merlin pcs) and remote monitoring software applications (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers. Pacemaker/battery functionality,…
RecallHealth product recall | 2022-06-27
Infrared Thermometer
Voluntary recall-interim order authorization not approved.
Recall start date: December 2, 2021
RecallHealth product recall | 2022-06-27
Fingertip Pulse Oximeter
Voluntary recall-interim order authorisation not approved.
Recall start date: December 2, 2021
RecallHealth product recall | 2022-06-27
Digital Thermometer
Voluntary recall- interim order authorisation not approved.
Recall start date: December 2, 2021
RecallHealth product recall | 2022-06-27
Defigard Touch7
In rare cases, when the device is switched on directly in defibrillator mode, cancellations of heart rhythm analysis after 30 seconds have been reported.
Recall start date: June 17, 2022
RecallHealth product recall | 2022-06-27
Aquac Uno H Reverse Osmosis System - Main Unit
On June 14, 2022, the manufacturer Fresenius Medical Care Ag & Co. Kgaa notified Fresenius Medical Care Canada, Inc. that during regular quality inspections of Aquac Uno H devices, it was discovered that the internal ethernet cable had not been…
RecallHealth product recall | 2022-06-27
Tps System - Elite Burs
During internal product/process review (April 2022), it was discovered that there is a potential for the core diameter to be undersized, which may lead to the router breaking. To date, Stryker has not been made aware of any adverse events related to this…
RecallHealth product recall | 2022-06-27
Intraosseous Powered Drive and Needle Kits
1. Difficulty separating stylet from needle, which could result in inadvertent removal of the entire needle assembly or inability to remove the stylet from an indwelling intraosseous needle, both resulting in functional loss of intraosseous access. 2.…
RecallHealth product recall | 2022-06-27
JAMP recalls vitamin D3:Out of Specification
The dissolution for vitamin D3 is out of specification in the affected lot.
RecallHealth product recall | 2022-06-22
Global PET-CT Tables
During a specific servicing activity, if the wrong screws are removed by the service personnel without the appropriate table supports in place, there is the potential for the table to drop.
Recall start date: June 6, 2022
RecallHealth product recall | 2022-06-20
Alinity and Architect A1C Reagent Kit
This recall is to inform of a potential for falsely elevated hemoglobin %A1C and hemoglobin A1C patient results to be generated using the architect hemoglobin A1C assay when analyzing whole blood or hemolysate samples with poor sample integrity, due to…
RecallHealth product recall | 2022-06-20
Cholestech Ldx Total, HDL, Triglycerides Cholesterol and Glucose Test
Alere San Diego has identified that bilirubin interference level listed in the package insert is incorrect. Concentrations less than 5.0 mg/dl can impact the accuracy of triglyceride (TRG) and High-density lipoproteins (HDL). Bilirubin levels of 2.0 mg/…
RecallHealth product recall | 2022-06-20
Palindrome/Mahurkar Chronic Catheter
Medtronic has identified a potential leaking condition within the hub of specific chronic hemodialysis catheters. Flushing one extension tube may result in unanticipated fluid return through the adjacent extension tube (in addition to the anticipated…
RecallHealth product recall | 2022-06-20
Coolsculpting System - Applicator - Vacuum
Zeltiq Aesthetics, Inc. is voluntarily discontinuing and recalling Coolsculpting parallel plate applicators (Coolcore, Coolcurve, Coolcurve+, Coolmax, and Coolfit applicators) due to the observance of a slightly increased rate of paradoxical hyperplasia…
RecallHealth product recall | 2022-06-20