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.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
The recalling firm identified a software issue related to the Patient Line Check (PLC) which may result in an increased risk of Overfill (also known as Increased Intraperitoneal Volume,…
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct…
The device may process the same sample with two different sample IDs and sample information while using the single tube loader, which has the potential for erroneous results due to the…
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
The infusion sets were manufactured with an incorrect spin collar.
After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.
A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable.
BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels causing erroneous results that could delay treatment for health conditions such…
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
The infusion sets were manufactured with an incorrect spin collar.
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot…
The infusion sets were manufactured with an incorrect spin collar.
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
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.
