Complete FDA and NHTSA recall records dated in 2018, 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.
The drill guides were manufactured with the incorrect color anodization.
if the cables of the Monica IF24 System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed…
The incorrect placement of AA batteries into certain LeadCare Plus Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the…
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
The microscope may tip over if attachments are fully extended in one line and there is an attempt to move the device not by the handles mounted on the post.
The battery is integral to the device. If the device sits unused and is not charged for a lengthy period of time (a few months) the battery will go into a deep discharge state and the…
The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the…
The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Coconut smiles product tested positive for Salmonella.
During an FDA inspection the firm was notified that the product was mislabeled due to the label indicating that the product contains cream when the firm actually uses evaporated milk and…
A blue plastic bag was inadvertently introduced into product stream. During the manufacturing process, the blue plastic bag was torn into many pieces and ended up in the finished product.…
Product tested positive for Salmonella.
Tamarack Inc. is recalling Eclipse Kratom-containing powder products because it may be contaminated with Salmonella.
Coconut flour tested positive for Salmonella.
Failed Dissolution Specifications; during stability testing
Failed Dissolution Specifications; during stability testing
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to…
It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and…
The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Some complaints were also associated with transient over…
The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.
Complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters.
Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters.
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.
