Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 1702

The newest recall records with useful source details are listed here.

Medical DeviceFeb 1, 2017

The Binding Site Group Optilite IgG4 Kit Product Code: LK009.OPT.A recall — FDA Z-1089-2017

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…

Class IIIFDA: TerminatedThe Binding Site Group, Ltd.

Medical DeviceFeb 1, 2017

Philips Electronics Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and recall — FDA Z-0925-2017

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.

Class IIFDA: TerminatedPhilips Electronics North America Corporation

Medical DeviceFeb 1, 2017

Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evacuate air and/or recall — FDA Z-1088-2017

Outer Packaging is not sterile

Class IIFDA: TerminatedAtrium Medical Corporation

Medical DeviceFeb 1, 2017

The Binding Site Group Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II recall — FDA Z-1071-2017

Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.

Class IIFDA: TerminatedThe Binding Site Group, Ltd.

Medical DeviceFeb 1, 2017

PerkinElmer Health Sciences Program Update Package AutoDELFIA 3.0, Fluorometer, for clinical recall — FDA Z-1101-2017

AutoDELFIA System with Version 3.0 Software: Potential plate loading failures

Class IIIFDA: TerminatedPerkinElmer Health Sciences, Inc.

Medical DeviceFeb 1, 2017

Smiths Medical ASD NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100 recall — FDA Z-1105-2017

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)…

Class IIFDA: TerminatedSmiths Medical ASD, Inc.

Medical DeviceFeb 1, 2017

Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery drain recall — FDA Z-1082-2017

Outer Packaging is not sterile

Class IIFDA: TerminatedAtrium Medical Corporation

Medical DeviceFeb 1, 2017

Philips Electronics Allura Xper FD10 722026 is intended for: Cardiovascular and vascular recall — FDA Z-0923-2017

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.

Class IIFDA: TerminatedPhilips Electronics North America Corporation

Medical DeviceFeb 1, 2017

Villa Radiology Systems Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of recall — FDA Z-1066-2017

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…

Class IIFDA: OngoingVilla Radiology Systems LLC

Medical DeviceFeb 1, 2017

Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors recall — FDA Z-1079-2017

Outer Packaging is not sterile

Class IIFDA: TerminatedAtrium Medical Corporation

Medical DeviceFeb 1, 2017

Acumedia Manufacturers Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes recall — FDA Z-1093-2017

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…

Class IIFDA: TerminatedAcumedia Manufacturers, Inc.

Medical DeviceFeb 1, 2017

On-X Life Technologies Chord-X Chordal Sizer is designed to assist in determining the proper recall — FDA Z-1057-2017

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…

Class IIFDA: TerminatedOn-X Life Technologies, Inc.

Medical DeviceFeb 1, 2017

The Binding Site Group Human lgG4 Subclass Liquid Reagent Kits For use on the Roche recall — FDA Z-1069-2017

Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.

Class IIFDA: TerminatedThe Binding Site Group, Ltd.

Medical DeviceFeb 1, 2017

Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean Infant/Pediatric recall — FDA Z-1081-2017

Outer Packaging is not sterile

Class IIFDA: TerminatedAtrium Medical Corporation

Medical DeviceFeb 1, 2017

Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue recall — FDA Z-1106-2017

May experience a loss of centralized monitoring.

Class IIFDA: TerminatedPhilips Electronics North America Corporation

Medical DeviceFeb 1, 2017

Villa Radiology Systems Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable recall — FDA Z-1065-2017

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…

Class IIFDA: OngoingVilla Radiology Systems LLC

Medical DeviceFeb 1, 2017

Baxter Healthcare Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system recall — FDA Z-1095-2017

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…

Class IIFDA: TerminatedBaxter Healthcare Corporation

Medical DeviceFeb 1, 2017

Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single drain with in-line recall — FDA Z-1083-2017

Outer Packaging is not sterile

Class IIFDA: TerminatedAtrium Medical Corporation

Medical DeviceFeb 1, 2017

Roche Diagnostics Operations Cobas b 123 POC system The cobas b 123 POC system is a fully recall — FDA Z-1077-2017

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…

Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.

Medical DeviceFeb 1, 2017

Medline Industries Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box recall — FDA Z-1074-2017

Medline Industries, Inc is recalling Unna Z Unna Boot Bandage 3X10 and Unna Z Unna Boot Bandage 4X10 due to contamination of the products with common mold (Cladosporium…

Class IIFDA: TerminatedMedline Industries Inc.

Medical DeviceFeb 1, 2017

Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with recall — FDA Z-1084-2017

Outer Packaging is not sterile

Class IIFDA: TerminatedAtrium Medical Corporation

Medical DeviceFeb 1, 2017

GE OEC Medical Systems OEC 9800. MDL Numbers: D222250, D141598 recall — FDA Z-1059-2017

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…

Class IIFDA: TerminatedGE OEC Medical Systems, Inc.

Medical DeviceFeb 1, 2017

Roche Diabetes Care Accu-Chek Connect Diabetes Management App recall — FDA Z-1099-2017

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…

Class IIFDA: TerminatedRoche Diabetes Care, Inc.

Medical DeviceFeb 1, 2017

The Binding Site Group Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser recall — FDA Z-1067-2017

Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.

Class IIFDA: TerminatedThe Binding Site Group, Ltd.

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