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

20176–20200 of 40248

ModerateFDA (Devices)·Z-1993-2019·2019-07-31
Abbott Haptoglobin Assay Recalled for Instruction Manual Updates
Abbott Laboratories is recalling 5,694 Haptoglobin Assay kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.
Product
The,K -ASSAY HP assay is intended for the quantitative determination of human haptoglobin by immunoturbidimetric assay. The antiserum used in the kit was produced against purified human haptoglobin. The haptoglobin antibody interacts with the haptoglobin in the serum forming…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2024-2019·2019-07-31
Siemens AXIOM Artis dFA Recalled for Power Supply Tolerance Issue
Siemens is recalling 39 AXIOM Artis dFA units because a power supply issue may cause generator failure, preventing X-ray production during procedures.
Product
AXIOM Artis dFA, Model Number 7555373
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2006-2019·2019-07-31
Terumo 30G Needle Recall Due to Potential Sterility Compromise
Terumo Medical Corporation is recalling 81,000 30G needles due to a potential loss of package integrity that may compromise sterility.
Product
Terumo Needle, 30G x 1/2", Product Code NN3013R
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-1998-2019·2019-07-31
Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity
Terumo Medical Corporation is recalling 729,000 Sur-vet Needles because a potential loss of package integrity may compromise the sterility of the product.
Product
Terumo Sur-vet Needle, 20G x 1", Product Code 100204
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-2017-2019·2019-07-31
Siemens AXIOM Artis dBC X-ray System Recalled for Power Supply Issue
Siemens is recalling one AXIOM Artis dBC X-ray system because a power supply defect may prevent X-ray generation during procedures.
Product
AXIOM Artis dBC, Model Number 5917054
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2033-2019·2019-07-31
Siemens Artis zee Biplane Recalled for Power Supply Tolerance Issue
Siemens Medical Solutions is recalling three Artis zee biplane MN units due to a power supply tolerance issue that may prevent X-ray generation during procedures.
Product
Artis zee biplane MN, Model Number 10094143
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2013-2019·2019-07-31
Siemens AXIOM Artis FA X-ray Generator Recall for Power Supply Issue
Siemens is recalling four AXIOM Artis FA units due to a power supply tolerance issue that may cause generator failure and prevent X-ray imaging.
Product
AXIOM Artis FA, Model Number 5904441
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2085-2019·2019-07-31
CellEra Recalls VITALE Silicon Foam Dressings Due to Adhesive Defect
CellEra LLC is recalling 2,110 units of VITALE Silicon Foam Dressings because the adhesive border was not sticky enough.
Product
VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2016-2019·2019-07-31
Siemens AXIOM Artis BA X-ray Systems Recalled for Power Supply Defect
Siemens is recalling seven AXIOM Artis BA X-ray systems because a power supply defect may cause the generator to fail, preventing X-ray imaging.
Product
AXIOM Artis BA, Model Number 5904656
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1987-2019·2019-07-31
Abbott C3 In Vitro Diagnostic Assay Recall for Instruction Manual Update
Abbott Laboratories is recalling 8,132 C3 in vitro diagnostic kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.
Product
C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma. Antibodies to C3 combine with C3 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2078-2019·2019-07-31
Abbott Recalls ARCHITECT BNP Calibrators Due to Stability Drift
Abbott Laboratories is recalling 5,483 units of ARCHITECT BNP Calibrators worldwide due to a time-dependent stability drift that affects patient and control test results.
Product
ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2069-2019·2019-07-31
Epimed Versa-Kath Mini Kit Recalled for Incorrect Catheter Size Labeling
Epimed International is recalling 98 Versa-Kath Mini Kits because the labeling incorrectly states the kit contains a 12-gauge catheter, while it actually contains a 21-gauge catheter.
Product
Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 31129344 for epidural or caudal anesthesia
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-2061-2019·2019-07-31
Medela Breast Milk Transfer Lid Recall for Packaging Sterility Concerns
Medela Inc is recalling 665,600 breast milk transfer lids because packaging breaches may compromise sterility, even if the packaging appears intact.
Product
Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2063-2019·2019-07-31
Merge OrthoPACS Software Recalled for Image Display Ordering Issues
Merge Healthcare is recalling 73 units of Merge OrthoPACS software due to potential display errors in image ordering and scrolling.
Product
Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2018-2019·2019-07-31
Siemens AXIOM Artis TA X-ray Generator Recall for Power Supply Issue
Siemens is recalling five AXIOM Artis TA units due to a power supply tolerance issue that can cause generator failure and prevent X-ray imaging.
Product
AXIOM Artis TA, Model Number 7007755
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2015-2019·2019-07-31
Siemens AXIOM Artis BC X-ray Generator Recall Due to Power Supply Issue
Siemens is recalling six AXIOM Artis BC units because a power supply tolerance issue may cause the X-ray generator to fail during procedures.
Product
AXIOM Artis BC, Model Number 5904649
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2027-2019·2019-07-31
Siemens AXIOM Artis dBC X-ray Generator Recall for Power Supply Defect
Siemens is recalling 53 AXIOM Artis dBC units due to a power supply tolerance issue that can cause generator failure and prevent X-ray imaging.
Product
AXIOM Artis dBC, Model Number 7728392
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2021-2019·2019-07-31
Siemens AXIOM Artis dTC X-ray Generator Recall for Power Supply Defect
Siemens is recalling 98 AXIOM Artis dTC units because a power supply tolerance issue may cause generator failure, preventing X-ray imaging.
Product
AXIOM Artis dTC, Model Number 7413078
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2079-2019·2019-07-31
Abbott Recalls ARCHITECT BNP Controls Due to Stability Drift
Abbott Laboratories is recalling ARCHITECT BNP Controls because of a time-dependent stability drift that affects test results.
Product
ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination of…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1912-2019·2019-07-24
Teleflex Neonatal Breathing Circuit Recall Due to Cracked Adaptors
Teleflex is recalling 20 units of Neonatal ConchaSmart Breathing Circuits due to reported cracks on swivel wye adaptors observed prior to use.
Product
Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a) REF 870-07KIT b) REF 870-09KIT Product Usage: The Neonatal ConchaSmart breathing circuits are intended to deliver humidified breathing gases for administration to…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1940-2019·2019-07-24
Datascope Cardiosave Rescue IABP Recalled for Battery Maintenance Issues
Datascope Corp. is recalling 6,197 Cardiosave Rescue IABP units because improper battery maintenance may result in less than minimum operating power.
Product
Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1977-2019·2019-07-24
FDA Recalls Advincula Delineator Uterine Manipulator Due to Cracking Risk
CooperSurgical is recalling 213 units of the Advincula Delineator Uterine Manipulator because the soft cup may crack during use, posing a risk of lacerations.
Product
Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy…
Category
Medical Device
Distribution
14 states
SevereFDA (Devices)·Z-1943-2019·2019-07-24
Datascope CS300 Intra-Aortic Balloon Pump Recalled for Battery Maintenance Issues
Datascope Corp. is recalling CS300 Intra-Aortic Balloon Pumps because improper battery maintenance may result in less than minimum run time.
Product
CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascular use.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1768-2019·2019-07-24
CareFusion Recalls Alaris Pump Model 8100 Due to Bezel Plastic Weakening
CareFusion is recalling Alaris Pump Model 8100 units manufactured between April 2011 and June 2017 because the bezel plastic may weaken, potentially causing infusion errors.
Product
Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this recall as they are pumps or pump assemblies with bezels manufactured between April 2011 and June 2017 with the FR-110 plastic.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1942-2019·2019-07-24
Datascope CS100 Intra-Aortic Balloon Pump Recalled for Battery Maintenance Issues
Datascope Corp. is recalling CS100 Intra-Aortic Balloon Pumps because improper battery maintenance may result in less than the minimum run time of operating power.
Product
CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascular use.
Category
Medical Device
Distribution
Distributed nationwide

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20176–20200 of 40248