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 10 critical, 40 moderate, and 0 lower-severity recalls. The page references 26 distinct recalling firms operating in 6 distinct product categories, with 43 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (33), FDA Food (7), NHTSA (6), 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 Jan 20, 2021

Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Jan 20, 2021

Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

GE Healthcare, LLC

FDA Devices Moderate Jan 20, 2021

The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. The analyzer is intended to be used as an in-vitro diagnostic or screening system providing real time PCR amplification and detection for human samples within the system. The cobas x 480 instrument and cobas z 480 analyzer are to be used by laboratory professionals trained in laboratory techniques and by instruction on the use of the system and ana

Roche Molecular Systems, Inc.

FDA Devices Moderate Jan 20, 2021

Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prolapse and for use in the repair of rectal prolapse excluding rectocele.

Baxter Healthcare Corporation

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

Philips North America, LLC

FDA Devices Moderate Jan 20, 2021

Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Jan 20, 2021

Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings, Inc.

FDA Devices Critical Jan 20, 2021

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 08714729940821, Made in Ireland, Ballybrit Business Park, Galway, Ireland.

Boston Scientific Corporation

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

EXOGEN Ultrasound Coupling Gel

Bioventus, LLC

FDA Devices Moderate Jan 20, 2021

icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician.

ICU Medical, Inc.

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292

Ortho Clinical Diagnostics Inc

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COVID-19 Test is only for use under the Food and Drug Administration s Emergency Use Authorization.

VISBY MEDICAL INC

FDA Devices Moderate Jan 20, 2021

Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478 (12 count) - Product Usage: for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.

Clerio Vision

FDA Devices Moderate Jan 20, 2021

Citrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings, Inc.

FDA Devices Critical Jan 20, 2021

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVS230, GTIN 08714729940814, Made in Ireland, Ballybrit Business Park, Galway, Ireland.

Boston Scientific Corporation

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Fresenius Medical Care Holdings, Inc.

NHTSA No agency class Jan 20, 2021

NISSAN 2013-2015: EXTERIOR LIGHTING:BRAKE LIGHTS:SWITCH

NISSAN

NHTSA No agency class Jan 20, 2021

FREIGHTLINER,WESTERN STAR 2021: SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS:DISC:CALIPER

FREIGHTLINER,WESTERN STAR

NHTSA No agency class Jan 20, 2021

RAM 2020: SUSPENSION:REAR

RAM

CPSC No agency class Jan 19, 2021

Rapala USA Recalls Rechargeable Fillet Knives Due to Fire Hazard

Rapala USA, of Minnetonka, Minn.

NHTSA No agency class Jan 15, 2021

LINCOLN 2020: VISIBILITY:WINDSHIELD WIPER/WASHER

LINCOLN

NHTSA No agency class Jan 15, 2021

FORD,LINCOLN 2020-2021: POWER TRAIN:DRIVELINE:DRIVESHAFT

FORD,LINCOLN

USDA FSIS Critical Jan 15, 2021

Nestlé Prepared Foods Recalls Not-Ready-to-Eat Pepperoni Hot Pockets Product Due to Possible Foreign Matter Contamination

USDA FSIS Moderate Jan 15, 2021

FSIS Issues Public Health Alert for Beef Jerky Products Due to Misbranding and an Undeclared Allergen

CPSC No agency class Jan 14, 2021

Scalpa Recalls Scalpa Numb Maximum Strength Topical Anesthetic Cream Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)

Scalpa Inc., of Phoenix, Ariz.

NHTSA No agency class Jan 14, 2021

HONDA 2018-2021: FUEL SYSTEM, GASOLINE:STORAGE

HONDA

FDA Food Moderate Jan 13, 2021

OUR SPECIALTY; Cake Truffles; Variety; Chocolate; Cookies 'N Creme; NO: Artificial Colors, Flavors, or High Fructose Corn Syrup; Net Wt. 19.5 oz(1 LB 3.5 oz) (552 g)

Rich Products Corp

FDA Food Moderate Jan 13, 2021

Avalanche Distributing, LLC

FDA Food Moderate Jan 13, 2021

HRV Carrot.Cubes 1/20LB/HRV DCD Cartos 1/20LB - bag in box product in a corrugated case; IQF Cartotte Cubes 3/8" 1/25LB/IQF Diced Cartos 3/8" 1/25LB - bag in box product in corrugated case; Classic Carot Cubes 12/2LB/Classic DCD Carrots 12/2LB - corrugated cases of 12 individual printed poly bags

Bonduelle Canada Inc.

FDA Food Moderate Jan 13, 2021

Party Tray Vegetables with Ranch Dip, packaged in 40 oz (2.5 LBS) plastic tray with lid, UPC 3825911509.

Country Fresh Orlando, LLC

FDA Food Moderate Jan 13, 2021

GE Mixed Veg (4) 12/32oz/GE Mixed Veg (4) 12/32oz - packed in corrugated cases of 12 individual printed poly bags

Bonduelle Canada Inc.

FDA Food Moderate Jan 13, 2021

HRV Carot.&Pois 1/20LB/HRV Carrot & Peas 1/20LB - bag in box product in corrugated case

Bonduelle Canada Inc.

FDA Food Critical Jan 13, 2021

9" French Silk Base, Item 7545, Count per case 6 Ea., Case Weight 12 lb. 3 oz. UPC 50796220075458. Keep Frozen.

American Blue Ribbon Holdings LLC

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 November 2026.