PlainRecalls

2021 Recall Year Insight

Federal agencies issued 5,231 product recalls indexed by PlainRecalls in calendar year 2021. That represents about 5.01% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 14.3 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 105 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 2021.

On this page of 50 records, severity classification shows 20 critical, 29 moderate, and 1 lower-severity recalls. The page references 23 distinct recalling firms operating in 8 distinct product categories, with 29 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (25), NHTSA (8), FDA Food (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 2021 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 Critical May 19, 2021

Kit: Blood Culture. MAI Kit Part Number: 80315D

Medical Action Industries, Inc. 306

FDA Devices Moderate May 19, 2021

REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros" - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. Fresenius P/N 24-2500-0 All 3 units make up the AquaBplus 2500Fresenius Part Number: G02040109-US AquaBplus 3000 - Typ USA G02040115-US AquaBplus 2500 - Typ USA G02040120FMC-US AquaBplus HF- Typ USA

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate May 19, 2021

NM/CT 870 DR Nuclear Medicine / CT Scanners

GE Healthcare, LLC

FDA Devices Moderate May 19, 2021

Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-resistance enterococci (VRE) from surveillance cultures.

Remel Inc

FDA Devices Critical May 19, 2021

Kit: Midline Insertion DA. MAI Kit Part Number: 77981B

Medical Action Industries, Inc. 306

FDA Devices Moderate May 19, 2021

Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Protocol file for RNA-based assay, and install the Assay Definition File (ADF) file

Meridian Bioscience Inc

FDA Devices Moderate May 19, 2021

PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)00801741027406 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

Bard Peripheral Vascular Inc

FDA Devices Moderate May 19, 2021

REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein)

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

ICU Medical, Inc.

FDA Devices Critical May 19, 2021

Kit: Injection REVIEW MAI Kit Part Number: 74736

Medical Action Industries, Inc. 306

FDA Devices Moderate May 19, 2021

REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

ICU Medical, Inc.

FDA Devices Low May 19, 2021

VenaSeal Closure System

Medtronic Inc.

FDA Devices Moderate May 19, 2021

REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine Item Number: 227007

Musculoskeletal Transplant Foundation, Inc.

FDA Devices Moderate May 19, 2021

REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

NM/CT 850 Nuclear Medicine / CT Scanners

GE Healthcare, LLC

FDA Devices Moderate May 19, 2021

REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

ICU Medical, Inc.

FDA Devices Critical May 19, 2021

Kit: Blood Culture MAI Kit Part Number: 80076

Medical Action Industries, Inc. 306

FDA Devices Critical May 19, 2021

ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.

St. Jude Medical, Cardian Rhythm Management Division

CPSC No agency class May 19, 2021

Cheyenne Products Recalls Folding Chairs and Barstools Due to Fall Hazard

CPSC No agency class May 19, 2021

IKEA Recalls Bowls, Plates, and Mugs Due to Burn Hazard

NHTSA No agency class May 19, 2021

FREIGHTLINER,WESTERN STAR 2021-2022: STEERING:LINKAGES:TIE ROD ASSEMBLY

FREIGHTLINER,WESTERN STAR

NHTSA No agency class May 19, 2021

INTERNATIONAL 2019-2021: FUEL SYSTEM, DIESEL:FUEL INJECTION SYSTEM:FUEL RAIL

INTERNATIONAL

NHTSA No agency class May 17, 2021

PORSCHE 2021: SUSPENSION:FRONT

PORSCHE

NHTSA No agency class May 17, 2021

MERCEDES-BENZ 2019: ELECTRONIC STABILITY CONTROL (ESC):CONTROL MODULE:SOFTWARE

MERCEDES-BENZ

NHTSA No agency class May 17, 2021

MERCEDES-BENZ 2020: STRUCTURE:BODY:DOOR:HINGE AND ATTACHMENTS

MERCEDES-BENZ

USDA FSIS Critical May 17, 2021

Kraft Heinz Foods Company Recalls Chef Francisco Soup Product Due to Misbranding and Undeclared Allergens

Kraft Heinz Foods Company

NHTSA No agency class May 14, 2021

FREIGHTLINER 2017-2022: EXTERIOR LIGHTING:HEADLIGHTS:BULBS

FREIGHTLINER

NHTSA No agency class May 14, 2021

MERCEDES-BENZ 2019-2021: BACK OVER PREVENTION: SENSING SYSTEM: CAMERA

MERCEDES-BENZ

NHTSA No agency class May 14, 2021

MERCEDES-BENZ 2019-2021: LATCHES/LOCKS/LINKAGES:DOORS:LATCH

MERCEDES-BENZ

USDA FSIS Moderate May 14, 2021

FSIS Issues Public Health Alert for Ineligible Siluriformes Products Imported From Brazil

CPSC No agency class May 13, 2021

Alliance Chemical Recalls Sodium Hydroxide Products Due to Failure to Meet Child Resistant Packaging Requirement and Violation of FHSA Labeling (Recall Alert)

Alliance Chemical, of Taylor, Texas

CPSC No agency class May 13, 2021

BRP Recalls Snowmobiles Due to Fire Hazard (Recall Alert)

Bombardier Recreational Products Inc. of Canada

CPSC No agency class May 13, 2021

Leisure Time Products Recalls Brutus Swing Sets Due to Injury Hazard (Recall Alert)

CPSC No agency class May 13, 2021

Polaris Recalls RZR Recreational Off-Road Vehicles Due to Fire Hazard (Recall Alert)

CPSC No agency class May 13, 2021

The Lye Guy Recalls Sodium and Potassium Hydroxide Products Due to Failure to Meet Child Resistant Packaging Requirement and Violation of FHSA Labeling (Recall Alert)

The Lye Guy, of Pennellville, N.Y.

FDA Food Critical May 12, 2021

Velvet Cookies n Cream 16oz - 8 cartons to a case 3 Gallon Tub - 1 Tub per case

Velvet Ice Cream Company

FDA Food Critical May 12, 2021

Velvet Vanilla Bean 3 Gallon Tub - 1 Tub per Case

Velvet Ice Cream Company

FDA Food Moderate May 12, 2021

Granny's Fudge Gorgeous Peanut Brittle, net wt. 5oz. or 8 oz, packed in a clear plastic container. No UPC. Label declares "***Ingredients: Sugar, peanuts, corn syrup, butter, vanilla, baking soda***Allergy Information: Mfg on same equipment that processes wheat, egg, peanut & tree nut. May contain traces of soy, milk, peanuts & tree nuts***".

JKH Enterprises

FDA Food Moderate May 12, 2021

MRE LITE Animal Based Protein, Oatmeal Chocolate Chip, Animal Protein Powder Drink Mix, Net Wt. 30.69 oz (1.92lb) (870g)

REDCON1 LLC

FDA Food Critical May 12, 2021

Whale of Pail Vanilla Gallon Plastic Tub

Velvet Ice Cream Company

FDA Food Critical May 12, 2021

Velvet Vanilla Lovers Trio 56oz Carton - 4 Cartons per case

Velvet Ice Cream Company

FDA Food Critical May 12, 2021

Velvet Mint Chocolate Chip 3 Gallon Tub - 1 Tub per Case 56oz Carton - 4 Cartons per Case

Velvet Ice Cream Company

FDA Food Critical May 12, 2021

Guan's Enoki Mushroom - Champigons d'enoki; Net Wt./ Poids Net 200 g/ 7.05 oz.; 25 individual packages per box. Distributed by Guan's Mushroom Co., Los Angeles, Ca 90040 Ingredients - 100% Fresh Enoki Mushroom - Keep Refrigerated. Product of China UPC 8 10023 17030 3

Forest Mushroom Food Inc.

Nearby Recall Years

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

Compare 2021 with 2020 →

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 2021

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 2021 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.