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.
28,535 detailed records are currently available in this category.
Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potentially leading to an incorrect bolus insulin recommendation being provided to…
GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced…
Outer Packaging is not sterile
Medline Industries, Inc is recalling Unna Z Unna Boot Bandage 3 X10 and Unna Z Unna Boot Bandage 4 X10 due to contamination of the products with common mold (Cladosporium…
under specific settings, an issue may occur during simultaneous Sensor Cartridge and Fluid Pack change on the cobas b 123 <2> POC system and cobas b 123 <4> POC system. The issue occurs…
Outer Packaging is not sterile
Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone straight connectors…
The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a…
May experience a loss of centralized monitoring.
Outer Packaging is not sterile
Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Four issues were uncovered by the recalling firm's CAPA: 1) Burrs were found to be present on Left Housing, Right Housing and Barrel components, 2) Loose plastic particulate was found…
light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. While there is no change in growth performance of this medium, the formation of particulate…
Outer Packaging is not sterile
The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a…
Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
Outer Packaging is not sterile
Smiths Medical became aware that that one (1) NORMOFLO H-1100 Irrigation Fluid Warmers was incorrectly labelled with Spanish language labels instead of English labels. Specifically five (5)…
AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Outer Packaging is not sterile
Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the…
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.
