Complete FDA and NHTSA recall records dated in April 2018.
These records include useful source details for the selected month.
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.
There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result.
Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in the U.S. of select COACH Self-Adhering Sports Wraps, BAND-AID Brand First Aid Products…
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…
There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
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…
Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment…
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
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.
