Complete FDA and NHTSA recall records dated in 2021, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The…
There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller…
Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood…
There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller…
Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubation) and reduce the…
There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller…
The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (Left and Right) has the potential to fracture at the augment cut slot. This can occur in the…
Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubation) and reduce the…
Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.
Contact lenses may be mislabeled with the incorrect lens power.
There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller…
Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Use of a defective device is likely to require immediate…
Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood…
There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller…
ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have slits in the product…
Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC)…
Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC)…
There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller…
Non-conformity (holes/punctures or deep creases) in the sterile barrier.
The firm received positive test results for Listeria monocytogenes during in house environmental sampling on one of their meat slicers.
Ingredient containing mold was used in production
Vitamin D3 stability sample analyzed and found to be less than 100% of label claim.
The firm received positive test results for Listeria monocytogenes during in house environmental sampling on one of their meat slicers.
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.
