Complete FDA and NHTSA recall records dated in June 2021.
These records include useful source details for the selected month.
Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock
Not manufactured to specification
There is a potential leak between the venous patient connector and patient's hemodialysis access.
Due to a failure of the welds, the casters detached from the rear legs of the walker.
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not…
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not…
Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. The issue relates to the sterile barrier system for the product. During internal stress testing on PICO70…
The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required.
Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This carryover effect only occurs when the impacted assays are used immediately following testing…
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not…
IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope has been updated to notify users of the associated risks with the distal end cap…
Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501, and 502 analyzers and on the…
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not…
Removing parts for safety reasons due to possible breakage.
Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
Not manufactured to specification
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not…
specimens collected in transport media may result is false negative results when stored in certain conditions.
Not manufactured to specification
Product contains elevated levels of patulin.
Yeast was found in shelf stable 16 oz. aluminum can of Brew Dr. Uplift drink.
Potential to contain small foreign objects
Foreign material in product (plastic)
Yeast was found in shelf stable 16 oz. aluminum can of Brew Dr. Uplift drink.
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.
