Complete FDA and NHTSA recall records dated in May 2022.
These records include useful source details for the selected month.
First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor. If the NIBP is not set to Neonatal,…
Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent,…
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false positives or false negatives).
Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can…
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
A potato stick snack with a milk allergen was found in the O-Organic Sea Salt Popcorn line's recycle chute.
Deficient packaging material potentially leading to premature spoilage.
Product contains cyclamate, an unapproved color.
Deficient packaging material potentially leading to premature spoilage.
Deficient packaging material potentially leading to premature spoilage.
Potential contamination with peanut while label does not declare peanut.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
