Complete FDA and NHTSA recall records dated in April 2018.
These records include useful source details for the selected month.
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…
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.
An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using Dimension Vista LOCI 8 Calibrator lot 7CD076 to calibrate…
During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in…
Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box…
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
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…
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…
The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.
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…
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…
Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.
Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes…
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…
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.
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…
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.
