Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
25,099 detailed records are currently available in this category.
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully.
Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic…
Carry bar may detach during use of mobile lifts and ceiling lifts equipped with the Swifthook component.
Disposable face masks labeled as non-medical were distributed to customers expecting medical use face masks.
Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of…
Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic…
Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not…
Due to the potential for fluid ingress into the Arm which could affect the device's electrical system and lead to a failure of the locking mechanism
The third-party brand latex micro surgical gloves packaged within specific custom packs may have a degradation defect that could lead to holes and donning tears at the folding area around…
The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the hand-piece did not receive proper premarket clearance from US FDA and lacks a…
Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2)…
Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of…
The firm has identified lots of calibrators that have shown to measure incorrect high values over time compared to the assigned values when released for distribution. This could result in…
Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connections could…
There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration…
Intermittent failure of a signal being sent to a monitor from the touch panel display causing the displaying monitor to go Blank and the touch panel to display a Blank image when reviewing…
Potential exists for the collision supervision not to work properly following loss of the individual room configuration data settings causing danger of collision with fix mounted room…
The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of being…
The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of being…
During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system.
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
