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 firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse…
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or…
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse…
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus,…
Potential for Capio sutures to break and /or detach.
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus,…
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Potential for Capio sutures to break and /or detach.
Potential for Capio sutures to break and /or detach.
Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus,…
There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus,…
Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old.
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.
