PlainRecalls

2020 Recall Year Insight

Federal agencies issued 6,048 product recalls indexed by PlainRecalls in calendar year 2020. That represents about 5.79% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 16.6 recalls per day across the FDA, CPSC, USDA FSIS, and NHTSA combined. Year-level views are the cleanest way to see macro patterns: volume spikes often correlate with new regulatory priorities (e.g., infant-sleep products after 2021, lithium-ion batteries after 2022), supply-chain contamination events, or changes in agency enforcement intensity, while quiet years can reflect either genuine product-safety improvements or reduced agency staffing and reporting lag. With 121 pages at 50 recalls each, browsing this year end-to-end gives a statistically representative sample of what the federal recall pipeline looked like in 2020.

On this page of 50 records, severity classification shows 9 critical, 41 moderate, and 0 lower-severity recalls. The page references 33 distinct recalling firms operating in 8 distinct product categories, with 43 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (25), FDA Food (9), CPSC (8), which matters because each agency's recall authority, hazard framing, and remedy mechanism differ, an FDA food recall, a CPSC consumer-product recall, and a NHTSA vehicle recall are legally distinct instruments even when the underlying hazard language sounds similar. Reviewing the dominant agency for a given year is one of the fastest ways to understand where federal attention was concentrated.

Year-indexed browsing serves three practical purposes: historical research (tracking how a hazard class evolved over time), consumer action (finding whether a product purchased in 2020 was later recalled), and journalistic or regulatory context (understanding what the enforcement landscape looked like in a given period). Every record on this page links to a full detail view with the hazard, remedy, distribution, and agency-assigned recall number, always use that recall number to verify current status directly with the issuing agency before acting on time-sensitive remedies, because agencies amend, terminate, and expand recalls in the months and years after initial publication. Data on this page reflects federal agency public filings; the agency's live record remains authoritative for legal, medical, or safety decisions. Verify with FDA openFDA, CPSC, USDA FSIS, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate May 20, 2020

TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.

Cardiac Assist, Inc

FDA Devices Moderate May 20, 2020

Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel with a slotted tube configuration. It is pre-mounted on an over-the-wire balloon catheter, which serves as the delivery system. The stent is positioned between two radiopaque marker bands, which are located inside the balloon at the proximal and distal tapers of the balloon.

Cook Inc.

FDA Devices Moderate May 20, 2020

SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.

C.R. Bard Inc

FDA Devices Moderate May 20, 2020

Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressure readings and/or frequent blood gas measurements are required. Case Label: Arterial Line Kit/1 20ga x 3", Qty: 10/CS, CE 2797

Argon Medical Devices, Inc

FDA Devices Moderate May 20, 2020

Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray,18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P18XTS - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.

Covidien Llc

FDA Devices Moderate May 20, 2020

Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 50456-01

ICU Medical, Inc.

FDA Devices Moderate May 20, 2020

Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Foley Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P16TS - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.

Covidien Llc

FDA Devices Moderate May 20, 2020

Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-25.

ICU Medical, Inc.

FDA Devices Moderate May 20, 2020

EVA Floor Lifts, Model Numbers: 400, 450, 600

Handicare AB

FDA Devices Moderate May 20, 2020

Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

The Magstim Company Limited

FDA Devices Moderate May 20, 2020

TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.

Cardiac Assist, Inc

FDA Devices Moderate May 20, 2020

Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P16XTSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.

Covidien Llc

FDA Devices Moderate May 20, 2020

Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-23.

ICU Medical, Inc.

FDA Devices Moderate May 20, 2020

Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41406-23

ICU Medical, Inc.

FDA Devices Moderate May 20, 2020

Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 20, 2020

Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulatory or non-ambulatory human patient (includes infants and adults).

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate May 20, 2020

Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41411-25

ICU Medical, Inc.

FDA Devices Moderate May 20, 2020

SWIN 2017 database, Model YSW4000

Remel Inc.

FDA Devices Moderate May 20, 2020

iQ200 Series Urine Microscopy Analyzer- All part numbers

Beckman Coulter Inc.

FDA Devices Moderate May 20, 2020

TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.

Cardiac Assist, Inc

FDA Devices Moderate May 20, 2020

TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.

Cardiac Assist, Inc

FDA Devices Moderate May 20, 2020

Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.

W. L. Gore & Associates Inc.

FDA Devices Moderate May 20, 2020

BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick Kit. REF/UDI / 94123/10859821006473 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.

Access Scientific LLC

FDA Devices Moderate May 20, 2020

BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max Barrier Kit. REF/UDI / 94107/10859821006206 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.

Access Scientific LLC

FDA Devices Moderate May 20, 2020

Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressure readings and/or frequent blood gas measurements are required. Case Label: Arterial Line Kit 20ga x 3", Ref 498411B, Qty: 10/CS

Argon Medical Devices, Inc

CPSC No agency class May 20, 2020

Bunz Kidz Children's Sleepwear Sets Recalled by Stargate Apparel Due to Violation of Federal Flammability Standard; Burn Hazard

Stargate Apparel, of New York

NHTSA No agency class May 20, 2020

TOYOTA 2019-2020: SUSPENSION:FRONT:CONTROL ARM:LOWER ARM

TOYOTA

NHTSA No agency class May 20, 2020

INTERNATIONAL 2019-2020: ELECTRICAL SYSTEM:SOFTWARE

INTERNATIONAL

NHTSA No agency class May 20, 2020

BMW,MINI 2020-2021: AIR BAGS: AIR BAG/RESTRAINT CONTROL MODULE

BMW,MINI

NHTSA No agency class May 18, 2020

WESTERN STAR 2019-2021: ELECTRICAL SYSTEM:WIRING

WESTERN STAR

NHTSA No agency class May 18, 2020

MITSUBISHI 2019-2020: SEAT BELTS:REAR/OTHER

MITSUBISHI

NHTSA No agency class May 18, 2020

MITSUBISHI 2008-2016: STRUCTURE:FRAME AND MEMBERS

MITSUBISHI

NHTSA No agency class May 15, 2020

DODGE 2016-2019: FUEL SYSTEM, GASOLINE:STORAGE:TANK ASSEMBLY

DODGE

CPSC No agency class May 14, 2020

Aromatics International Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)

Aromatics International LLC, of Florence, Mont.

CPSC No agency class May 14, 2020

Flybar Recalls Swurfer Baby and Toddler Swings Due to Fall Hazard

CPSC No agency class May 14, 2020

Garia Recalls Golf & Courtesy Electric Vehicles Due to Fire Hazard

Garia A/S, of Denmark

CPSC No agency class May 14, 2020

John Deere Recalls Attachment Kits for Compact Utility Tractor Brooms Due to Injury Hazard (Recall Alert)

Deere & Company, of Moline, Illinois

CPSC No agency class May 14, 2020

Organic Pure Oil Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning; Sold Exclusively on Amazon.com (Recall Alert)

Organic Pure Oil, of Santa Ana, Calif.

CPSC No agency class May 14, 2020

Sterno Home Recalls Path Light Kits With LED Power Supplies Due to Shock Hazard

Sterno Home Inc., of Canada

CPSC No agency class May 14, 2020

W8 Distributing Recalls Jade Bloom Wintergreen and Birch Sweet Essential Oils Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)

W8 Distributing dba Jade Bloom, of Draper, Utah

FDA Food Moderate May 13, 2020

12", 10" Pressed Wheat Flour Tortillas, packaged in quantities of 1-2 dozen per package. Each package is twist-tied and placed in a box. Box is then sealed for delivery.

La Sonorense, Inc.

FDA Food Moderate May 13, 2020

Simply Nature Organic Red Split Lentils, 16 oz bag, UPC 041498299507

Aldi Inc

FDA Food Moderate May 13, 2020

Simply Nature Organic Green Lentils, 16 oz bag, UPC 041498299514

Aldi Inc

FDA Food Critical May 13, 2020

Optavia, Old Fashioned Maple & Brown Sugar Oatmeal . 1.13 oz./ 32 g pouch, Multi-layer Kraft paper/aluminum pouches, Seven pouches per carton

Jason Pharmaceuticals, Inc. t/a Medifast

FDA Food Moderate May 13, 2020

14", 10" Hand Stretched Whole Wheat Flour Tortillas, packaged in quantities of 1-2 dozen per package. Each package is twist-tied and placed in a box. Box is then sealed for delivery.

La Sonorense, Inc.

FDA Food Moderate May 13, 2020

Benefiber Healthy Shape Prebiotic Fiber Supplement, 500G UPC 886790018872

Glaxosmithkline Consumer Healthcare Holdings

FDA Food Critical May 13, 2020

TAINY BOCTOKA DRY FRUITS MIX COMPOT APPLE; Assorted dried fruits; NET WT 17.63 oz (500g) clear plastic package

Royal International Trading Inc.

FDA Food Moderate May 13, 2020

Benefiber Prebiotic Fiber Supplement, packaged in the following ways 1) Net Wt. 500 g (17.6 oz) bottle. UPC 886790218302 and 2) Net Wt. 760 g bottle UPC 8886790211907

Glaxosmithkline Consumer Healthcare Holdings

FDA Food Moderate May 13, 2020

16", 14", 13", 12", 10", 5" Hand Stretched Wheat Flour Tortillas, packaged in quantities of 1-2 dozen per package. Each package is twist-tied and placed in a box. Box is then sealed for delivery.

La Sonorense, Inc.

FDA Drug Moderate May 13, 2020

Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2, Rx Only, Distributed by: Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA, NDC 54643-5647-0

Sandoz, Inc

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2020 with 2019 →

Data Sources

  • Source: FDA openFDA Enforcement API - calendar-year recall filings for food, drugs, and devices
  • Source: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2020

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS and NHTSA recall records; no number is typed in by an editor. Figures cover calendar year 2020 across the FDA, CPSC, USDA FSIS and NHTSA federal recall feeds. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of September 2026.