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

14076–14100 of 27471

HighFDA (Devices)·Z-1425-2020·2020-03-11
Beckman Coulter Recalls Direct Bilirubin Reagents Due to Interference Risk
Beckman Coulter is recalling Direct Bilirubin Reagents because acetaminophen metabolites may interfere with test results, potentially delaying diagnosis and treatment.
Product
Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575120(200 tests/cartridge) and 15099590625603(300 tests/cartridge)
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-1361-2020·2020-03-11
CareFusion Alaris Syringe Module Software Error Recall
CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units due to software errors that may cause infusion interruptions or incorrect medication concentrations.
Product
CareFusion Alaris Syringe Module, Model 8110
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1431-2020·2020-03-11
Bard Biopsy EnCor Probe Recall for Sterility and Function Defects
Bard Peripheral Vascular Inc is recalling specific lots of Bard Biopsy EnCor Probes due to leaks, suction issues, and failure to obtain samples.
Product
Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Category
Medical Device
Distribution
30 states
HighFDA (Devices)·Z-1413-2020·2020-03-11
DeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination
DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
Product
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack 89-6015.16
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1359-2020·2020-03-11
CareFusion Alaris PC Unit Software Error Recall
CareFusion is recalling Alaris PC units due to software errors that may cause infusion interruptions, alarm failures, or incorrect medication concentrations.
Product
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1416-2020·2020-03-11
DeRoyal Sterile Custom Kits Recalled Due to Unknown Contamination Levels
DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
Product
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid Pack 89-6302.14
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1422-2020·2020-03-11
Beckman Coulter Enzymatic Creatinine Reagent Recalled for Potential Diagnostic Interference
Beckman Coulter is recalling Enzymatic Creatinine Reagents because high levels of acetaminophen metabolites may interfere with test results, potentially delaying diagnosis.
Product
Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-1423-2020·2020-03-11
Beckman Coulter Recalls Triglycerides Reagent Due to Acetaminophen Interference
Beckman Coulter is recalling Triglycerides Reagent because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.
Product
Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233228
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-1445-2020·2020-03-11
Stryker Connected OR Cart Recalled Due to Monitor Attachment Defect
Stryker is recalling 12 Connected OR Carts because the monitor may not attach correctly, posing a risk of the monitor falling and injuring users.
Product
Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for: Stryker, 5900 Optical Court, San Jose, CA 95138, UDI: 07613327462784 - Product Usage: The Connect OR Cart is a mobile, medical-grade cart intended to store and transport components of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1421-2020·2020-03-11
Siemens Atellica CH Reaction Ring Segment Recalled for Cuvette Defects
Siemens Healthcare Diagnostics is recalling Atellica CH Reaction Ring Segments because defects may allow water contamination, leading to inaccurate test results.
Product
Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1418-2020·2020-03-11
DeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination
DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
Product
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Kwik Kit 89-6389.06
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1432-2020·2020-03-11
Bard Biopsy EnCor Probe Recall for Performance Failures
Bard Peripheral Vascular Inc is recalling specific lots of Bard Biopsy EnCor Probes due to performance failures including leaks and suction issues.
Product
Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Category
Medical Device
Distribution
30 states
HighFDA (Devices)·Z-1429-2020·2020-03-11
Seca Baby Scale Cart Recalled Due to Wheel Detachment Risk
Seca is recalling 254 baby scale carts because wheels can loosen and detach, causing the cart to tip over and potentially injure a baby.
Product
Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-1417-2020·2020-03-11
DeRoyal Sterile Custom Kits Recalled for Unknown Contamination Levels
DeRoyal is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
Product
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1443-2020·2020-03-11
RespVent Closed Suction System Tracheostomy T-Piece Recall for Connection Defect
Respiratory Therapeutics Group is recalling RespVent Closed Suction System T-Pieces because catheters may not be tightly connected to the thumb port, potentially reducing suction performance.
Product
RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suction Catheter, Sterile R, RxOnly, Reorder Number: RTG-02300, UDI: 00850108006035 - Product Usage: To be used to aspirate liquids or semi…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1426-2020·2020-03-11
Beckman Coulter Total Bilirubin Reagent Recalled for Acetaminophen Interference
Beckman Coulter is recalling Total Bilirubin Reagents because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.
Product
Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233075 (300 tests/cartridge) and 15099590625597 (400 tests/cartridge)
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-1411-2020·2020-03-11
DeRoyal Sterile Custom Kits Recalled for Unknown Contamination
DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden and particulate contamination.
Product
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Chronic Ear Pack 89-4393.17
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1410-2020·2020-03-11
DeRoyal Sterile Custom Kits Recalled for Unknown Contamination
DeRoyal Industries is recalling 2,100 sterile custom kits containing Cardinal Health gowns due to unknown bioburden and particulate contamination.
Product
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1444-2020·2020-03-11
Roche Recalls Elecsys CA 19-9 Reagent Due to Non-Reproducible Results
Roche Diagnostics is recalling 684 units of Elecsys CA 19-9 reagent because non-reproducible elevated results may affect clinical interpretation.
Product
Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1439-2020·2020-03-11
Vyaire Medical Recalls bellavista 1000 Ventilators Due to Alarm Failures
Vyaire Medical is recalling 116 bellavista 1000 ventilators because they may fail to sound high-priority alarms or respond to touch screen input.
Product
bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air and high-pressure oxygen. Air enters through a fresh gas intake port and is…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1360-2020·2020-03-11
CareFusion Alaris Pump Module Recalled for Software Errors
CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units due to software errors that may cause infusion interruptions or incorrect medication concentrations.
Product
CareFusion Alaris Pump Module, Model 8100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1447-2020·2020-03-11
Recall of Force TriVerse Electrosurgical Kits Due to Sterility Concerns
Covidien is recalling Force TriVerse Electrosurgical Kits distributed in EMEA due to potential sterile packaging compromise, which may increase infection risk.
Product
Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East, and Africa) only. No US distribution. Kits are manufactured in The Netherlands. Item codes BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1409-2020·2020-03-11
Baxter Recalls Revaclear 300 Dialyzers Due to Potential Foreign Matter
Baxter Healthcare is recalling Revaclear 300 Capillary Dialyzers because of the potential presence of particular matter in the header caps of ten lots.
Product
Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1440-2020·2020-03-11
Invivo Recalls MRI Monitor Adapters Due to Insufficient Shielding
Invivo Corporation is recalling 75 SensaVue DVI adapters for MRI monitors because they have insufficient shielding. The units were distributed in the U.S. and several foreign countries.
Product
Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-1424-2020·2020-03-11
Beckman Coulter Uric Acid Reagent Recalled for Acetaminophen Interference
Beckman Coulter is recalling Uric Acid Reagents because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.
Product
Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575281
Category
Medical Device
Distribution
48 states

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14076–14100 of 27471