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.
23,306 detailed records are currently available in this category.
Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are…
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation…
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and…
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to…
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Priority Alarm (v1.0.0, v1.1.0,…
Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation…
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Loss of connectivity between the FlexArm and the Table due to a software issue.
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer…
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to…
Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two…
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstr¿m Carestation/Pro…
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to…
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.
