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

27826–27850 of 40357

ModerateFDA (Devices)·Z-1067-2017·2017-02-01
Binding Site Human IgG Subclass Kit Recalled for Inaccurate Results
The Binding Site Group is recalling Human IgG Subclass Kits because they may produce falsely low results for patients with extremely high IgG4 levels.
Product
Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code LK009.IM This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1082-2017·2017-02-01
Atrium Medical Recalls Ocean Blood Recovery Drains Due to Sterility Issues
Atrium Medical is recalling Ocean Blood Recovery Drains because the outer packaging is not sterile. The recall affects units worldwide with expiration dates prior to October 2019.
Product
Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery drain with in-line connector and suction control stopcock 2050-300 Ocean Blood Recovery drain with suction control stopcock, no in-line connector 2052-000 Ocean Double Blood Recovery drain…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1058-2017·2017-02-01
Philips Brilliance iCT Recalled for Potential Improper Torque on Rotor Bolt
Philips Medical Systems is recalling a Brilliance iCT unit in Australia because a rotor counterweight bolt may have been improperly torqued.
Product
Brilliance iCT
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1068-2017·2017-02-01
Binding Site IgG4 Subclass Kit Recalled for Inaccurate Results
The Binding Site Group is recalling Human IgG4 Subclass kits because high IgG4 levels can cause spuriously low results.
Product
Human lgG4 Subclass kit for use on the Beckman Coulter AU" series This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1093-2017·2017-02-01
Acumedia Tryptic Soy Agar Recalled Due to Precipitate Formation
Acumedia is recalling Tryptic Soy Agar because precipitate may form in plates, potentially leading to inaccurate microbial counts.
Product
Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes
Category
Medical Device
Distribution
21 states
ModerateFDA (Devices)·Z-1078-2017·2017-02-01
Sekisui Diagnostics Ammonia L3K Assay Recalled for Performance Issues
Sekisui Diagnostics is recalling specific lots of the Ammonia L3K Assay because atypical optical density decreases may impact performance at the high end of the linear range.
Product
Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-1100-2017·2017-02-01
PerkinElmer AutoDELFIA Plate Processor Recalled for Potential Loading Failures
PerkinElmer is recalling AutoDELFIA Plate Processors with Version 3.0 software due to potential plate loading failures that could affect clinical assay results.
Product
AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1057-2017·2017-02-01
On-X Chord-X Chordal Sizer Recalled for Manufacturing Defects
On-X Life Technologies is recalling 45 units of the Chord-X Chordal Sizer due to manufacturing defects including burrs, particulate, hair, and assembly errors.
Product
Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve…
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-1086-2017·2017-02-01
Atrium Medical Recalls Oasis Blood Recovery Drains Due to Sterility Issues
Atrium Medical is recalling Oasis Blood Recovery Drains because the outer packaging is not sterile. The recall covers units with expiration dates prior to October 2019.
Product
Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis Blood Recovery drain with in-line connector 3652-100 Oasis Double Blood Recovery drain with in-line connectors - 2 patient lines connected by one Y connector Product Usage: To evacuate air and/or fluid…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1087-2017·2017-02-01
Atrium Medical 400 Series Express Drains Recalled for Non-Sterile Packaging
Atrium Medical is recalling 400 Series Express Drains because the outer packaging is not sterile. The recall affects approximately 1.4 million cases distributed worldwide.
Product
Atrium Medical 400 Series Express Drains as follows: 4000-100N Express single collection drain with in-line connector 4000-100P Express PreFilled Chest Drain 4020-100N Express dual chamber drain with in-line connectors ( 2 Patient Tubes) 4050-100N Express Blood Recovery…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1072-2017·2017-02-01
Binding Site IgG Subclass Reagent Kits Recalled for Inaccurate Results
The Binding Site Group is recalling Human IgG Subclass Liquid Reagent Kits because high IgG4 levels can cause spuriously low test results.
Product
Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product Code: NK001.T This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1071-2017·2017-02-01
Binding Site IgG4 Reagent Kits Recalled for Inaccurate Results
The Binding Site Group is recalling Human IgG4 Subclass Liquid Reagent Kits because they may yield spuriously low results for samples with extremely high IgG4 levels.
Product
Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser Product Code: NK009.T This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1073-2017·2017-02-01
Binding Site IgG4 Kit Recalled for Inaccurate Results in High Levels
The Binding Site Group is recalling MininephThl Human IgG4 Kits because samples with extremely high IgG4 levels may yield spuriously low results.
Product
MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1084-2017·2017-02-01
Atrium Medical Oasis Pediatric Drain Recalled for Non-Sterile Packaging
Atrium Medical is recalling Oasis Pediatric Drains because the outer packaging is not sterile. The recall covers 964,463 US cases and 521,975 international cases.
Product
Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with in-line connector, ¿ in. tubing, Sims and Pedi connector in bag on back of drain 3612-400 Oasis Infant/Pediatric drain with no in-line connector, ¿ in. tubing, Sims and Pedi connector…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1088-2017·2017-02-01
Atrium Medical Express Mini 500 Dry Seal Drain Recall
Atrium Medical is recalling Express Mini 500 dry seal drains because the outer packaging is not sterile.
Product
Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1104-2017·2017-02-01
Mesa Laboratories Recalls ProSpore Biological Indicators Due to Reduced Resistance
Mesa Laboratories is recalling ProSpore 4 mL Ampoule Biological Indicators because product resistance fell outside label claims within the expiration date.
Product
ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care…
Category
Medical Device
Distribution
11 states
LowFDA (Devices)·Z-1102-2017·2017-02-01
PerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures
PerkinElmer is recalling AutoDELFIA systems with V3.0 software due to potential plate loading failures that could affect clinical assay results.
Product
DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1101-2017·2017-02-01
PerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures
PerkinElmer is recalling AutoDELFIA systems with Version 3.0 software due to potential plate loading failures that could affect clinical assay results.
Product
Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1105-2017·2017-02-01
Smiths Medical Recalls NORMFlow H-1100 Irrigation Fluid Warmer for Labeling Errors
Smiths Medical is recalling one NORMFlow H-1100 Irrigation Fluid Warmer in Sweden due to incorrect Spanish labels instead of English.
Product
NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230. Product Usage: NORMOFLO¿ H-1100 Irrigation Fluid Warmers has been designed for safe, in-line warming of irrigating fluids as they are administered to patients. The Fluid Warmer…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1075-2017·2017-02-01
Pentax Rigid Laryngostroboscopes Field Correction for Instructions for Use
Pentax of America is revising the Instructions for Use for Rigid Laryngostroboscopes Models 9106 and 9108.
Product
Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1089-2017·2017-02-01
Binding Site IgG4 Kit Recalled for Incorrect Product Insert Information
The Binding Site Group is recalling Optilite IgG4 Kits because the product insert does not reflect a change to the measuring range.
Product
Optilite IgG4 Kit Product Code: LK009.OPT.A
Category
Medical Device
Distribution
8 states
LowFDA (Devices)·Z-1060-2017·2017-02-01
GE OEC 9900 Elite Surgical Carts Recalled for Documentation Updates
GE Healthcare is updating user documentation for OEC 9900 Elite surgical carts to clarify maintenance and component replacement frequencies.
Product
OEC 9900 Elite. MDL Numbers: D148942, D155043
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1059-2017·2017-02-01
GE OEC 9800 Surgical Table Field Action for Documentation Updates
GE Healthcare is updating user documentation for OEC 9800 surgical tables to clarify maintenance and component replacement schedules.
Product
OEC 9800. MDL Numbers: D222250, D141598
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0970-2017·2017-01-25
Bard Halo One Introducer Sheath Recalled for Separation and Kinking
Bard Peripheral Vascular is recalling Halo One 5F Introducer Sheaths due to complaints of sheath separation, kinking, and tip damage during use.
Product
Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1044-2017·2017-01-25
Elekta Monaco RTP System Recalled for Incorrect Dose Calculation Errors
Elekta, Inc. is recalling the Monaco RTP System because editing beam numbers and wedge angles can result in incorrect dose calculations for radiation therapy patients.
Product
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Category
Medical Device
Distribution
27 states

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27826–27850 of 40357