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 2 critical, 47 moderate, and 1 lower-severity recalls. The page references 17 distinct recalling firms operating in 5 distinct product categories, with 48 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (44), CPSC (4), NHTSA (2), 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 Jun 30, 2021

Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. Disposable & sterile. Transparent. Self light; A.4519/MPR Short - Multi Purpose Rectoscope. 190mm long. Sterile & Disposable; A.4086/EPOFLIER - Surgical kit made of a 34,3mm wide anoscope and an opened retractor named GULL. Disposable & sterile; A.4084/THE BEAK Diagnostic- Disposable proctoscope. Transparent. Sterile & Self lighting; A.4522/ MPR - Multi Pu

Adler MicroMed, Inc.

FDA Devices Moderate Jun 30, 2021

ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862

Cardinal Health Inc.

FDA Devices Moderate Jun 30, 2021

Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.

Pear Therapeutics, Inc.

FDA Devices Moderate Jun 30, 2021

LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component.

Smith & Nephew, Inc.

FDA Devices Moderate Jun 30, 2021

FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877

Cardinal Health Inc.

FDA Devices Moderate Jun 30, 2021

novaplus, General Purpose Kit, Cat. No. 56603

Medical Action Industries, Inc. 306

FDA Devices Moderate Jun 30, 2021

FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084

Cardinal Health Inc.

FDA Devices Moderate Jun 30, 2021

DEXCOM G6 SENSOR 3 PACK Item Number: 5447552

Cardinal Health Inc.

FDA Devices Moderate Jun 30, 2021

reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.

Pear Therapeutics, Inc.

FDA Devices Moderate Jun 30, 2021

Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174

Cardinal Health Inc.

FDA Devices Moderate Jun 30, 2021

VAPORIZER VICKS 1.5GAL Item Number: 2354942

Cardinal Health Inc.

FDA Devices Low Jun 30, 2021

inLight Medical LED Pads used with Polychromatic light technology system

Inlightened Partners LLC

FDA Devices Moderate Jun 30, 2021

Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.

Philips Medical Systems Nederlands

FDA Devices Moderate Jun 30, 2021

Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort. Product Code: 1025ECP

EHOB, Inc.

FDA Devices Moderate Jun 30, 2021

FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144

BioFire Diagnostics, LLC

FDA Devices Moderate Jun 30, 2021

Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214

Medical Action Industries, Inc. 306

FDA Devices Moderate Jun 30, 2021

6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, REF 56224

Medical Action Industries, Inc. 306

FDA Devices Moderate Jun 30, 2021

Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610

Cardinal Health Inc.

FDA Devices Moderate Jun 30, 2021

Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

BD UF PEN 32GX4MM 100 NANO Item Number: 4292272

Cardinal Health Inc.

FDA Devices Moderate Jun 30, 2021

Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

Medical Action INDUSTRIES INC., General Purpose Instrument Tray, REF 61209

Medical Action Industries, Inc. 306

FDA Devices Moderate Jun 30, 2021

Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751

Beckman Coulter Inc.

FDA Devices Moderate Jun 30, 2021

ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443

Cardinal Health Inc.

FDA Devices Moderate Jun 30, 2021

Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application

GE Healthcare, LLC

FDA Devices Moderate Jun 30, 2021

AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033

Cardinal Health Inc.

FDA Devices Moderate Jun 30, 2021

6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item ID: A-AU-10- 058N

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

FREESTYLE LANCETS 28G 100CT Item Number:2975670

Cardinal Health Inc.

FDA Devices Moderate Jun 30, 2021

ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628

Cardinal Health Inc.

FDA Devices Moderate Jun 30, 2021

BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338

BioFire Diagnostics, LLC

FDA Devices Moderate Jun 30, 2021

Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22

Exact Medical Manufacturing, Inc.

FDA Devices Moderate Jun 30, 2021

ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788

Cardinal Health Inc.

FDA Devices Moderate Jun 30, 2021

Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat, REF 56220

Medical Action Industries, Inc. 306

CPSC No agency class Jun 30, 2021

Children's Nightgowns Sold Exclusively on Amazon.com Recalled Due to Violation of Federal Flammability Standard and Burn Hazard; Manufactured by Auranso Official

Auranso Official, of Zhejiang, China

CPSC No agency class Jun 30, 2021

Children's Nightgowns Sold Exclusively on Amazon.com Recalled Due to Violation of Federal Flammability Standard and Burn Hazard; Manufactured by Booph

Booph, of Shenzhen, China

CPSC No agency class Jun 30, 2021

Children's Robes Sold Exclusively on Amazon.com Recalled Due to Violation of Federal Flammability Standard and Burn Hazard; Manufactured by SIORO

SIORO, of Wuhan, China

CPSC No agency class Jun 30, 2021

UPPAbaby Recalls Adapters Included with RumbleSeats Due to Child Fall Hazard

NHTSA No agency class Jun 30, 2021

PORSCHE 2021: STEERING:COLUMN

PORSCHE

NHTSA No agency class Jun 30, 2021

VOLKSWAGEN 2020-2021: AIR BAGS: AIR BAG/RESTRAINT CONTROL MODULE

VOLKSWAGEN

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.