Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

34826–34850 of 40449

ModerateFDA (Devices)·Z-2656-2014·2014-09-24
Zenith Slide W-I-D-E Long Term Care Bed Recall for Head Deck Failure
GF Health Products is recalling 1,941 Zenith Slide W-I-D-E Long Term Care Beds because the head deck may fail to elevate during normal operation.
Product
Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2664-2014·2014-09-24
Philips CT Systems Recalled for Software Image Overlap Defect
Philips is recalling Brilliance 64 and Ingenuity CT systems because CIRS 4.0 Beta 2 software may cause images to overlap during reconstruction.
Product
The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2630-2014·2014-09-24
Fresenius Recalls BD Vacutainer EDTA Tubes Due to Improper Storage
Fresenius Medical Care is recalling 26 boxes of BD Vacutainer EDTA tubes held at improper storage temperatures. The affected lots were distributed in Louisiana, Oklahoma, and Texas.
Product
BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 Part Number: FMC 87-7841-7 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2667-2014·2014-09-24
Genesis BPS Recalls Pedi-Pak Syringe Filters for Unreported Changes
Genesis BPS is recalling 7,560 units of Pedi-Pak Pedi-Syringe Filters because the company failed to notify the FDA of material changes to the device.
Product
Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2631-2014·2014-09-24
Fresenius Recalls BD Vacutainer SST Tubes for Improper Storage Temperature
Fresenius Medical Care is recalling 9 boxes of BD Vacutainer SST Tubes held at improper storage temperatures. The tubes were distributed in Louisiana, Oklahoma, and Texas.
Product
BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number: 87-7981-5 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. serum determination in…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2639-2014·2014-09-24
Amerx Recalls Amergel Hydrogel Gauze Dressing for Unapproved Labeling Claims
Amerx Health Care Corp. is recalling Amergel Hydrogel Saturated Gauze Dressing pads because the product labeling includes unapproved claims regarding antimicrobial and autolytic debridement properties.
Product
Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2632-2014·2014-09-24
Fresenius Recalls BD Vacutainer Trace Element Tubes Due to Storage Issues
Fresenius Medical Care is recalling specific BD Vacutainer Trace Element Tubes because they were held at improper storage temperatures. The affected units were distributed in Louisiana, Oklahoma, and Texas.
Product
BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 363083 Part Number: FMC 87-8380-1 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Trace elements…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2641-2014·2014-09-24
Amerx Recalls Amerigel Daily Dressing for Unapproved Labeling Claims
Amerx Health Care Corp. is recalling Amerigel Daily Dressing Advanced 3-in-1 Hydrogel because the product labeling includes unapproved claims for antimicrobial and autolytic debridement.
Product
Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2669-2014·2014-09-24
Genesis BPS Recalls Pediatric Blood Filter Syringes for Regulatory Non-Compliance
Genesis BPS, LLC is recalling 4,608 units of Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringes because the company failed to notify the FDA of material changes.
Product
Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2634-2014·2014-09-24
Fresenius Recalls BD Vacutainer PST Tubes Due to Improper Storage Temperature
Fresenius Medical Care is recalling BD Vacutainer PST Tubes because they were held at improper storage temperatures. The affected units were distributed in Louisiana, Oklahoma, and Texas.
Product
BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. The concentrate is formulated to…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2649-2014·2014-09-24
Siemens Axiom Luminos dRF Recalled for Fluid Infiltration Malfunction Risk
Siemens is recalling 33 Axiom Luminos dRF systems because fluid exposure to the tableside control panel may cause a malfunction and automatic shutdown.
Product
AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2629-2014·2014-09-24
Fresenius Recalls BD Vacutainer Serum Tubes Due to Improper Storage Temperature
Fresenius Medical Care is recalling 3 boxes of BD Vacutainer Serum Tubes because they were held at improper storage temperatures. The affected units were distributed in Louisiana, Oklahoma, and Texas.
Product
BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2655-2014·2014-09-24
B. Braun AccuFlo Elastomeric Infusion Device Labeling Recall
B. Braun Medical is recalling AccuFlo infusion devices in Missouri due to a mismatch between inner and outer packaging labels.
Product
B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2638-2014·2014-09-24
Amerx Recalls Amergel Wound Dressing Due to Unapproved Labeling Claims
Amerx Health Care Corp. is recalling Amergel Wound Dressing Maximum Strength because the product labeling contains unapproved claims regarding antimicrobial and autolytic debridement properties.
Product
Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2662-2014·2014-09-24
Siemens ADVIA Centaur Immunoassay System Field Correction for Sample Rack Loading
Siemens is correcting ADVIA Centaur systems where improperly loaded sample racks may cause sample ID misreads.
Product
ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2661-2014·2014-09-24
Teleflex Recalls Soft Rubber Bladder Catheters Due to Missing Latex Warning
Teleflex Medical is recalling sterile soft rubber bladder catheters because the product labels failed to include a Natural Rubber Latex caution statement.
Product
Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2646-2014·2014-09-24
Advanced Photonic Systems Recalls Luxurian Devices for Marketing Violations
Advanced Photonic Systems is recalling 235 Luxurian devices because they were marketed without FDA clearance or approval.
Product
Luxurian. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims…
Category
Medical Device
Distribution
24 states
ModerateFDA (Devices)·Z-2651-2014·2014-09-24
Beckman Coulter Recalls Coulter DxH Diluent Due to Elevated Platelet Background Counts
Beckman Coulter is recalling Coulter DxH Diluent because it may cause elevated platelet background counts, resulting in failed Daily Checks on specific Coulter Cellular Analysis Systems.
Product
Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types and the measurement…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2633-2014·2014-09-24
Fresenius Medical Care Recalls BD Vacutainer Citrate Tubes Due to Storage Issues
Fresenius Medical Care is recalling BD Vacutainer Citrate Tubes because they were held at improper storage temperatures. The affected tubes were distributed in Louisiana, Oklahoma, and Texas.
Product
BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Part Number: FMC 87-3083-8 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Coagulation studies.
Category
Medical Device
Distribution
3 states
LowFDA (Devices)·Z-2644-2014·2014-09-24
BioFire Defense Recalls JBAIDS Instrument System Software Version 3.5.0.72
BioFire Defense is recalling JBAIDS Instrument System Software version 3.5.0.72 because the wrong version may have been installed on the devices.
Product
JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and rapid identification of multiple biological warfare and clinical pathogens from a variety of biological specimens. The…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2650-2014·2014-09-24
Stago IVD Liquid Anti-Xa Recalled for Barcode Misreading
Diagnostica Stago is recalling 514 Liquid Anti-Xa kits due to customer complaints about barcode misreading on analyzers.
Product
Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2626-2014·2014-09-17
Stryker Recalls Aria Implant Inserters Due to Product Fracturing Complaints
Stryker Spine is recalling 64 units of Aria Standard and Specialty Implant Inserters due to complaints of product fracturing. The devices are used for spinal fusion procedures.
Product
Stryker Aria Implant Inserter, REF 48758500, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal…
Category
Medical Device
Distribution
24 states
SevereFDA (Devices)·Z-2627-2014·2014-09-17
Stryker Recalls Aria Inserter Devices Due to Product Fracturing
Stryker Spine is recalling 57 units of Aria Standard and Specialty Implant Inserters because of complaints that the instruments fractured.
Product
Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in…
Category
Medical Device
Distribution
24 states
SevereFDA (Devices)·Z-2608-2014·2014-09-17
Wright Medical Recalls CLAW II Straight Plates Due to Incorrect Raw Material
Wright Medical Technology is recalling 50 units of CLAW II Straight Plates because they were manufactured from an incorrect raw material.
Product
CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2617-2014·2014-09-17
GE Healthcare Recalls CARESCAPE Respiratory Modules Due to O2 Sensor Failure
GE Healthcare is recalling 748 CARESCAPE respiratory modules and Airway Gas Options due to a potential O2 sensor component failure.
Product
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with…
Category
Medical Device
Distribution
18 states

How to read this listing

Filters

34826–34850 of 40449