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

21726–21750 of 40339

HighFDA (Devices)·Z-0475-2019·2018-11-28
Tosoh AIA-2000 Analyzer Recall Due to Potential Wash Solution Defect
Tosoh Bioscience is recalling seven AIA-2000 analyzers because a liquid suction pump defect may cause incomplete washing, leading to inaccurate test results.
Product
AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0482-2019·2018-11-28
GE Healthcare Recalls Panda iRes Infant Radiant Warmers Due to Electric Leakage
GE Healthcare is recalling 1,724 Panda iRes Infant Radiant Warmers worldwide due to a potential electric leakage hazard that could affect users.
Product
Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0473-2019·2018-11-28
LeMaitre Vascular Recalls Unsealed Polyurethane Carotid Shunts
LeMaitre Vascular is recalling 46 units of Pruitt F3-S Polyurethane Outlying Carotid Shunts because the pouches are not sealed, compromising sterility.
Product
LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0483-2019·2018-11-28
GE Healthcare Recalls Panda Freestanding Infant Warmers Due to Electric Leakage
GE Healthcare is recalling 1,724 Panda Freestanding Infant Warmers worldwide due to a potential electric leakage hazard that could affect users.
Product
Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model. Infant Radiant warmer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0481-2019·2018-11-28
GE Healthcare Recalls Giraffe Infant Warmers Due to Electric Leakage Risk
GE Healthcare is recalling 1,724 Giraffe infant radiant warmers worldwide due to a potential electric leakage hazard that could affect users.
Product
Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0480-2019·2018-11-28
GE Healthcare Recalls Giraffe Incubator Carestations Due to Electric Leakage
GE Healthcare is recalling 1,724 Giraffe Incubator Carestations worldwide due to a potential electric leakage hazard that could affect users.
Product
Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0486-2019·2018-11-28
Ascom Telligence Nurse Call System Recalled for Communication Failure
Ascom (US) Inc. is recalling 57 units of the Telligence Nurse Call System because a gateway defect may prevent device failures from being displayed at staff consoles.
Product
Ascom Telligence Nurse Call System
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-0479-2019·2018-11-28
GE Healthcare Recalls Giraffe OmniBed Neonatal Incubators Due to Electric Leakage
GE Healthcare is recalling 1,724 Giraffe OmniBed Carestation neonatal incubators worldwide due to a potential electric leakage hazard that could affect users.
Product
Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0484-2019·2018-11-28
GE Healthcare Panda Wall Mount Infant Radiant Warmer Recalled for Electric Leakage
GE Healthcare is recalling 1,724 Panda Wall Mount infant radiant warmers worldwide due to a potential electric leakage hazard that could affect users.
Product
Panda Wall Mount warmer. Infant radiant warmer
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0489-2019·2018-11-28
Merck Minicon Clinical Sample Concentrators Recalled for Performance Issues
Merck Millipore is recalling Minicon Clinical Sample Concentrators because they may take up to 24 hours to concentrate samples, delaying diagnostic tests.
Product
Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) Minicon concentrators are non-sterile, disposable, multiwall ultrafiltration devices. Minicon¿ clinical sample concentrators are for in vitro diagnostic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0476-2019·2018-11-28
Ortho-Clinical VITROS dLDL Reagent Recalled for Negatively Biased Results
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products dLDL Reagent GENs 26 and 27 because the in vitro diagnostic may produce negatively biased results.
Product
VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0496-2019·2018-11-28
Zimmer Biomet Recalls Vanguard Knee System Due to Label Mismatch
Zimmer Biomet is recalling eight units of the Vanguard Knee System because the outer carton labels do not match the inner sterile packaging labels.
Product
Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-0487-2019·2018-11-28
FDA Mandates Recall of PremierPro Aluminum Adjustable Walkers
SVS LLC is recalling 256 PremierPro Aluminum Adjustable Walkers due to an FDA order for stock recovery and return of imported items.
Product
PremierPro Aluminum Adjustable Walker
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-0388-2019·2018-11-28
GE Healthcare Recalls DeltaVision OMX SR Imaging Systems Due to Interlock Defect
GE Healthcare Biosciences is recalling 39 DeltaVision OMX SR Imaging Systems because the safety interlocks are not wired to be single-fault tolerant.
Product
DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution imaging offluorescently-la beling biological samples. Techniques such as 3D Structured Illumination, Total Internal…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0493-2019·2018-11-28
BD Urine Collection Cups May Elevate Red Blood Cell Counts
Becton Dickinson is recalling urine collection cups that may cause slight red blood cell count elevations when used with specific analyzers.
Product
KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit for collection and transport of urine specimens for urinalysis
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0491-2019·2018-11-28
BD Vacutainer Urine Collection Cups Recalled for Potential RBC Count Elevation
Becton Dickinson is recalling BD Vacutainer Urine Collection Cups because they may cause slight elevations in red blood cell counts when used with specific analyzers.
Product
BD Vacutainer Urine Collection Cups, Cat. No. 364941
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0477-2019·2018-11-28
Binding Site Human IgM Kit Recalled for Reduced Accuracy
The Binding Site Group is recalling 108 units of Human IgM Kits due to reduced accuracy in control results and potential out-of-range readings.
Product
Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative…
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-0485-2019·2018-11-28
Tosoh AIA-900 Analyzer Software Issue May Delay Patient Testing
Tosoh is recalling three AIA-900 immunoassay analyzers due to a software issue that may cause reagent data errors, potentially delaying patient results.
Product
Tosoh AIA-900 immunoassay Analyzer
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0492-2019·2018-11-28
BD Vacutainer Urine Collection Cups Recalled for Potential RBC Count Elevation
Becton Dickinson is recalling BD Vacutainer Urine Collection Cups because they may cause slight elevations in red blood cell counts when used with specific analyzers.
Product
BD Vacutainer Specimen Collection Cups, Cat. No. 364975
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0494-2019·2018-11-28
BD Vacutainer Urine Cup Kit Recall for Potential RBC Count Elevation
Becton Dickinson is recalling BD Vacutainer Urine Cup Kits because they may cause slight red blood cell count elevations when used with specific analyzers.
Product
KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0495-2019·2018-11-28
Zimmer Biomet Recalls Vanguard Knee System Due to Label Mismatch
Zimmer Biomet is recalling 8 units of Vanguard Knee System femoral components because outer carton labels do not match inner sterile packaging labels.
Product
Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-0370-2019·2018-11-21
GE Healthcare Recalls Gamma Camera Systems Due to Falling Detector Risk
GE Healthcare is recalling 1,166 Millennium MG gamma camera systems because a detector can detach and fall.
Product
GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
Category
Medical Device
Distribution
50 states
SevereFDA (Devices)·Z-0448-2019·2018-11-21
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect
Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
Product
Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0417-2019·2018-11-21
AROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices
AROA Biosurgery is recalling OviTex Reinforced BioScaffold 10x12cm devices because the suture material degraded, causing them to fail burst specifications after 18 months.
Product
OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-0413-2019·2018-11-21
GE Healthcare Recalls Aisys Anesthesia System Touchscreen Display Kits
GE Healthcare is recalling 4,207 Aisys anesthesia system touchscreen display kits because they fail to transition to backup ventilation if a patient stops breathing.
Product
Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN, TOUCHSCREEN DISPLAY KIT 11.X DUTCH, TOUCHSCREEN DISPLAY KIT 11.X FRENCH, TOUCHSCREEN…
Category
Medical Device
Distribution
Distributed nationwide

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