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Displaying 1 - 15 of 50 items.
The sterility is out of specification in the affected lot (Periodic Media Fill Validation failure).
RecallHealth product recall | 2022-06-30
Product sold without market authorization. Affected lots are labelled with unauthorized claims.
RecallHealth product recall | 2022-06-30
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
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
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
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
The Benzalkonium Chloride assay is out of specification in the affected lot.
RecallHealth product recall | 2022-06-23
The dissolution for vitamin D3 is out of specification in the affected lot.
RecallHealth product recall | 2022-06-22
The products may contain undeclared ingredients which are listed on the Prescription Drug List.
RecallHealth product recall | 2022-06-21
Hillrom received reports of mislabeled fiberoptic Mac #1 laryngoscope blades (p/n 69061 lot 21-056). The outer box label stated Mac #1 laryngoscope blades (p/n 69061), but actually contained Mac #2 laryngoscope blades (p/n…
RecallHealth product recall | 2022-06-20
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
Siemens Healthcare Diagnostics Inc. has confirmed the occurrence of inconsistent discrepant (low bias) po2 results. at a medical decision level of approximately 80mmhg, the maximum negative bias is - 11.7% (the acceptable bias is +/-10% for po2 range 50-…
RecallHealth product recall | 2022-06-20
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
Rocky Mountain Soap Company recalls all lots of two Broadspectrum solar protection products due to quality concerns linked to deficiencies in Good Manufacturing Practices (GMP). The microbial content/ total aerobic microbial content may be out of…
RecallHealth product recall | 2022-06-16
Quality concerns of affected lots due to deficiencies in Good Manufacturing Practices (GMP). May contain undeclared impurity, methanol, at elevated levels.
RecallHealth product recall | 2022-06-16