Complete FDA and NHTSA recall records dated in 2023, 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.
Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.
Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System.
Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on how the slides are used. Falsely low…
Products were stored outside of labeled temperature requirements.
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5…
It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide…
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5…
Products were stored outside of labeled temperature requirements.
Endobronchial implant devices may have been labeled with a shortened expiration date but they can be used until the correct expiration date: 08 December 2024.
There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close…
North Carolina Department of Health and Human Services (NCDHHS) sampled product and found it to contain high levels of lead.
Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive
North Carolina Department of Health and Human Services (NCDHHS) sampled product and found it to contain high levels of lead.
Undeclared Peanut Butter; Packaged Peanut Butter Dough in Chocolate Chip packaging.
Incorrect product in packaging
North Carolina Department of Health and Human Services (NCDHHS) sampled product and found it to contain high levels of lead.
Lobster meat may be contaminated with Listeria monocytogenes.
Presence of Particulate Matter: identified as glass.
Failed Dissolution Specifications: Out of specification for dissolution.
CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active…
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay…
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.
