PlainRecalls

2021 Recalls

4,225 recalls · Page 6 of 85

2021 Recall Year Insight

Federal agencies issued 4,225 product recalls indexed by PlainRecalls in calendar year 2021. That represents about 5.03% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 11.6 recalls per day across the FDA, CPSC, NHTSA, and USDA FSIS 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 85 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 6 critical, 37 moderate, and 7 lower-severity recalls. The page references 33 distinct recalling firms operating in 6 distinct product categories, with 37 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (31), FDA Drug (6), NHTSA (5), 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, NHTSA, or USDA FSIS for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate Dec 8, 2021

Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring …

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Dec 8, 2021

The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 n…

MAX LUX CORP

FDA Devices Moderate Dec 8, 2021

INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS

Wright Medical Technology Inc

FDA Devices Moderate Dec 8, 2021

HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960

Boston Scientific Corporation

FDA Devices Moderate Dec 8, 2021

Total Thyroxine (T4) ELISA; REF EIA-1781

DRG International, Inc.

FDA Devices Moderate Dec 8, 2021

HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950

Boston Scientific Corporation

FDA Devices Moderate Dec 8, 2021

28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122

Howmedica Osteonics Corp.

FDA Devices Moderate Dec 8, 2021

NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5

Beeken Biomedical, LLC

FDA Devices Moderate Dec 8, 2021

Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring …

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Dec 8, 2021

RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200

Randox Laboratories Ltd.

FDA Devices Moderate Dec 8, 2021

28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028

Howmedica Osteonics Corp.

FDA Devices Moderate Dec 8, 2021

BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BAC…

BioFire Diagnostics, LLC

FDA Devices Moderate Dec 8, 2021

HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL

O&M HALYARD INC

FDA Devices Moderate Dec 8, 2021

HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900

Boston Scientific Corporation

FDA Devices Moderate Dec 8, 2021

The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23…

Magnolia Medical Technologies, Inc.

FDA Devices Moderate Dec 8, 2021

HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890

Boston Scientific Corporation

FDA Devices Moderate Dec 8, 2021

HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930

Boston Scientific Corporation

FDA Devices Moderate Dec 8, 2021

HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940

Boston Scientific Corporation

FDA Devices Moderate Dec 8, 2021

Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)

Thoratec Corp.

CPSC Moderate Dec 8, 2021

GE Appliances, a Haier Company, Recalls to Repair Free-Standing and Slide-In Ranges Due to Tip-Over Hazard

CPSC Moderate Dec 8, 2021

Mark of Fifth Avenue Children's Robes Recalled Due to Violation of Federal Flammability Standard and Burn Hazard

Mark of Fifth Avenue, of Harriman, N.Y.

NHTSA Critical Dec 8, 2021

AUDI 2018-2022: ELECTRICAL SYSTEM:BODY CONTROL MODULE/BCM

AUDI

NHTSA Critical Dec 7, 2021

HYUNDAI 2017-2019: ELECTRICAL SYSTEM:PROPULSION SYSTEM:CHARGING:MODULE:ONBOARD (OBCM)

HYUNDAI

CPSC Moderate Dec 6, 2021

Drive DeVilbiss Healthcare Recalls Adult Portable Bed Rails After Two Deaths; Entrapment and Asphyxiation Hazards

Drive DeVilbiss Healthcare, of Port Washington, New York

NHTSA Critical Dec 2, 2021

ACURA,HONDA 2021-2022: POWER TRAIN:DRIVELINE:DRIVESHAFT

ACURA,HONDA

NHTSA Critical Dec 2, 2021

HYUNDAI 2022: ELECTRICAL SYSTEM:SOFTWARE

HYUNDAI

NHTSA Critical Dec 2, 2021

HYUNDAI 2021: SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS:MASTER CYLINDER

HYUNDAI

FDA Food Low Dec 1, 2021

Mr. Special Jugo de Pina De Concentrado, 46 oz cans, packaged cardboard boxes 12 cans per case of 46 oz each

Empresas La Famosa, Inc.

FDA Food Critical Dec 1, 2021

MaryRuth's Organic Infants Liquid Probiotic; Unflavored, a Dietary Supplement. 1 fl. oz. (30 mL) UPC: 8 56645 00858 7 Serving size (five drops …

MARY RUTH ORGANICS

FDA Food Low Dec 1, 2021

Garden Side Salad 6.95oz. (197g) UPC:72251525202. Packaged in plastic containers.

Ukrop's Homestyle Foods, LLC

FDA Food Low Dec 1, 2021

Mexican Side Salad 6.95oz. (197g). Packaged in plastic containers.

Ukrop's Homestyle Foods, LLC

FDA Food Moderate Dec 1, 2021

Kings Hawaiian Hawaiian Sweet Hamburger Buns8 buns NET WT 12.8 oz. (362.9 g) UPC 0 73435-06050 Product Number 800020

King's Hawaiian Bakery

FDA Drug Low Dec 1, 2021

Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, Ind…

UNICHEM PHARMACEUTICALS USA INC

FDA Drug Low Dec 1, 2021

Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC: 71335-1767-09, barcode 083929164865; b) 20-count bottles, NDC: 71335-17…

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

FDA Drug Moderate Dec 1, 2021

Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 7051…

Teligent Pharma, Inc.

FDA Drug Low Dec 1, 2021

Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, East Windsor…

Aurobindo Pharma USA Inc.

FDA Drug Moderate Dec 1, 2021

Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 5256…

Teligent Pharma, Inc.

FDA Drug Low Dec 1, 2021

Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 60-count bottles, NDC: 63629-8…

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

FDA Devices Moderate Dec 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CCT) is a CT or PET/CT product…

Philips North America Llc

FDA Devices Moderate Dec 1, 2021

Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), R…

Medtronic Neuromodulation

FDA Devices Moderate Dec 1, 2021

Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model N…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Dec 1, 2021

Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602

Western/Scott Fetzer Company

FDA Devices Moderate Dec 1, 2021

Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDU…

Medtronic Vascular, Inc.

FDA Devices Moderate Dec 1, 2021

Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603

Western/Scott Fetzer Company

FDA Devices Moderate Dec 1, 2021

HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.

Instrumentation Laboratory

FDA Devices Moderate Dec 1, 2021

Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model N…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Dec 1, 2021

SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Dec 1, 2021

Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S

The Binding Site Group, Ltd.

FDA Devices Moderate Dec 1, 2021

The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and…

Intuitive Surgical, Inc.

FDA Devices Moderate Dec 1, 2021

Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE

Medtronic Vascular, 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: CPSC + NHTSA + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2021