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, 27 moderate, and 3 lower-severity recalls. The page references 38 distinct recalling firms operating in 8 distinct product categories, with 39 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (20), NHTSA (11), 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 Moderate Nov 10, 2021

FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)

Karl Storz Endoscopy

FDA Devices Critical Nov 10, 2021

IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical

Lumenis, Inc.

FDA Devices Moderate Nov 10, 2021

GM Helix Acqua Implant 3.5x10, Article No. 140.944

Jjgc Industria E Comercio De Materials Dentarios Sa

FDA Devices Moderate Nov 10, 2021

ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866

Siemens Healthcare Diagnostics, Inc

FDA Devices Moderate Nov 10, 2021

ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,

Implant Direct Sybron Manufacturing LLC

FDA Devices Moderate Nov 10, 2021

Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3

FujiFilm Healthcare Americas Corporation

FDA Devices Critical Nov 10, 2021

Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/Split Drape, AMS9957A Port Insertion Pack, and AMS12149 Procedure Pack

Windstone Medical Packaging, Inc.

FDA Devices Moderate Nov 10, 2021

Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3

FujiFilm Healthcare Americas Corporation

FDA Devices Moderate Nov 10, 2021

Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861

Siemens Healthcare Diagnostics, Inc

FDA Devices Moderate Nov 10, 2021

Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Nov 10, 2021

ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,

Implant Direct Sybron Manufacturing LLC

FDA Devices Moderate Nov 10, 2021

COVENA PICC Sleeve

Queen Comfort Products lLC

FDA Devices Moderate Nov 10, 2021

The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is designed to be loaded into the injector head of the injection system.

Bayer Medical Care, Inc.

FDA Devices Moderate Nov 10, 2021

Aspiration Syringe Kit, REF: MVSK60

MICROVENTION INC.

FDA Devices Moderate Nov 10, 2021

Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application Software, 10848815

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Nov 10, 2021

Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

FujiFilm Healthcare Americas Corporation

FDA Devices Moderate Nov 10, 2021

3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989), packaged 10 electrodes per card, 5 cards per pouch, 20 pouches per shipper box, 1,000 electrodes total per shipper box. The 3M Red Dot Radiolucent Monitoring Electrode with Foam Tape 2244 is intended to be used by healthcare professionals for ECG monitoring. This electrode is disposable, intended for single use, and has been tested for up to 3 days wear.

3M Company - Health Care Business

FDA Devices Moderate Nov 10, 2021

Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.

Cook Inc.

FDA Devices Moderate Nov 10, 2021

Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0

FujiFilm Healthcare Americas Corporation

FDA Devices Moderate Nov 10, 2021

Clinician Programmer Application (CPA) model A610 Clinician Software Application

Medtronic Neuromodulation

CPSC No agency class Nov 10, 2021

ABUS Recalls Youth Helmets Due to Risk of Head Injury

CPSC No agency class Nov 10, 2021

Hart Consumer Products Recalls Nailers Due to Injury Hazard; Sold Exclusively at Walmart

Techtronic Industries Vietnam Manufacturing Co., Ltd., of Vietnam

NHTSA No agency class Nov 10, 2021

AUDI 2017-2020: SEATS

AUDI

NHTSA No agency class Nov 10, 2021

JEEP 2021-2022: AIR BAGS: AIR BAG/RESTRAINT CONTROL MODULE:SOFTWARE

JEEP

NHTSA No agency class Nov 10, 2021

MASERATI 2021-2022: FUEL SYSTEM, GASOLINE:DELIVERY:HOSES, LINES/PIPING, AND FITTINGS

MASERATI

NHTSA No agency class Nov 10, 2021

RAM 2022: VISIBILITY:DEFROSTER/DEFOGGER/HVAC SYSTEM:WINDSHIELD:ELECTRICAL HEATING ELEMENT

RAM

NHTSA No agency class Nov 10, 2021

FORD,LINCOLN 2021: SUSPENSION:REAR

FORD,LINCOLN

NHTSA No agency class Nov 10, 2021

FORD 2021: ELECTRICAL SYSTEM:PROPULSION SYSTEM:TRACTION BATTERY

FORD

USDA FSIS Critical Nov 10, 2021

Innovative Solutions, Inc. Recalls Chicken Patty Products Due To Possible Foreign Matter Contamination

Innovative Solutions, Inc

USDA FSIS Critical Nov 10, 2021

Euro Foods Dba Citterio USA Corp. Recalls Salame Stick Products Due To Possible Salmonella Contamination

Euro Food, Inc., DBA Citterio USA Corporation

NHTSA No agency class Nov 9, 2021

TESLA 2021: AIR BAGS

TESLA

NHTSA No agency class Nov 5, 2021

WESTERN STAR 2022: STEERING

WESTERN STAR

NHTSA No agency class Nov 5, 2021

KIA 2020-2021: ELECTRICAL SYSTEM:INSTRUMENT PANEL:FUEL GAUGE

KIA

NHTSA No agency class Nov 5, 2021

ISUZU 2020: STEERING

ISUZU

NHTSA No agency class Nov 5, 2021

MERCEDES-BENZ 2021: AIR BAGS:SIDE/WINDOW

MERCEDES-BENZ

CPSC No agency class Nov 4, 2021

Backyard Play Systems Recalls Playsets with Wooden Roof Due to Entrapment Hazard (Recall Alert)

CPSC No agency class Nov 4, 2021

Kubota Recalls Utility Vehicles Due to Crash and Injury Hazards (Recall Alert)

Kubota Tractor Corporation, of Grapevine, Texas

FDA Food Critical Nov 3, 2021

Nature's Heart Superfood Trail Mix 1.5oz poly film pouches - 32 units per case

Nestle Usa Inc

FDA Food Moderate Nov 3, 2021

Almond Flour Crackers fine ground sea salt packaged in a white box with yellow graphics weighing 4.25 oz. Label reads "***Simple Mills***Almond Flour crackers Fine Ground Sea Salt***Net wT 4.25 oz***" UPC: 856069005131

SIMPLE MILLS

FDA Food Critical Nov 3, 2021

All products are stored refrigerated and labeled with Fullei Fresh brand. 10 lb Bean Sprouts in cardboard box; 5 lb Bean Sprouts in cardboard box; 8 bags of 8 oz Bean Sprout Pouches (Pouched then placed in cardboard box); 8 bags of 4 oz Organic Bean Sprouts (in plastic clamshell then in cardboard box); 5 lb Organic Bean Sprouts in cardboard box; 10 lb SOY Sprouts (ALLERGEN) in cardboard box; 5 lb SOY Sprouts (ALLERGEN) in cardboard box;

Kwokcheng Enterprise, Inc. dba Fullei Fresh

FDA Food Critical Nov 3, 2021

Nature's Heart Mango Turmeric Cashew Glazed Mix 1.5oz poly film pouches - 32 units per case

Nestle Usa Inc

FDA Food Moderate Nov 3, 2021

Food grade Anhydrous 94-97% Calcium Chloride Pellets, 50 lb. plastic bag

Occidental Chemical Corporation

FDA Food Critical Nov 3, 2021

Nature's Heart Pineapple Chili Cashew Glazed Mix 1.5oz poly film pouches - 32 units per case

Nestle Usa Inc

FDA Food Critical Nov 3, 2021

Nature's Heart Toasted Coconut Chips 1.5oz poly film pouches - 32 units per case

Nestle Usa Inc

FDA Food Moderate Nov 3, 2021

Simply Nature Organic Poppy Seed Dressing

Schlotterbeck & Foss LLC

FDA Drug Low Nov 3, 2021

Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA

MACLEODS PHARMA USA, INC

FDA Drug Moderate Nov 3, 2021

PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Low Nov 3, 2021

Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-094-41

MACLEODS PHARMA USA, INC

FDA Drug Low Nov 3, 2021

Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shipping Label)

Ultra Seal Corporation

FDA Drug Moderate Nov 3, 2021

METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

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.