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Displaying 1 - 15 of 45 items.
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
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
Siemens Healthcare Diagnostics Inc. has confirmed that Dimension Cardiac Troponin I (lTni and CTnI) lots (ea2314 and ga2323) shows a positive bias with lithium heparin plasma samples from individuals that are expected to be below the 99th percentile of 0…
RecallHealth product recall | 2022-06-13
During the manufacturing process, there is a slight risk of the formation of a hole in the sterile packaging which typically forms near the pre-sealed area at the bottom of the sterile packaging of the Yelloport Elite Universal Seals.
Recall start…
RecallHealth product recall | 2022-06-13
A software update for Carelink Smartsync™ device managers (Smartsync) will address a telemetry error that may occur with Medtronic Cobalt™ and Crome™ Implantable Cardioverter Defibrillators (ICDS), and Cardiac Resynchronization Therapy Defibrillators (…
RecallHealth product recall | 2022-06-03
Presence of an unspecified impurity near the acceptable concentration limit in the affected lot.
RecallHealth product recall | 2022-06-02
All lots contain an undeclared ingredient (sildenafil) that is listed on the prescription drug list.
RecallHealth product recall | 2022-06-01