PlainRecalls

2021 Recalls

5,168 recalls · Page 42 of 104

2021 Recall Year Insight

Federal agencies issued 5,168 product recalls indexed by PlainRecalls in calendar year 2021. That represents about 5.08% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 14.2 recalls per day across the FDA, CPSC, 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 104 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 9 critical, 41 moderate, and 0 lower-severity recalls. The page references 26 distinct recalling firms operating in 6 distinct product categories, with 45 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (33), CPSC (12), 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, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Critical Aug 18, 2021

HeartWare HVAD Implant Kit, REF 1104JP

Heartware, Inc.

FDA Devices Moderate Aug 18, 2021

MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx O…

Merit Medical Systems, Inc.

FDA Devices Critical Aug 18, 2021

Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.

Baxter Healthcare Corporation

FDA Devices Moderate Aug 18, 2021

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM Item Number: 11-301354

Biomet, Inc.

FDA Devices Moderate Aug 18, 2021

CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323

Richard Wolf GmbH

FDA Devices Critical Aug 18, 2021

HeartWare HVAD Driveline Extension Cable, REF 100US

Heartware, Inc.

FDA Devices Moderate Aug 18, 2021

Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000

Medtronic Neuromodulation

FDA Devices Moderate Aug 18, 2021

Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewi…

Edwards Lifesciences, LLC

FDA Devices Moderate Aug 18, 2021

GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"

Carl Zeiss Meditec, Inc.

FDA Devices Moderate Aug 18, 2021

IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For…

Merit Medical Systems, Inc.

FDA Devices Moderate Aug 18, 2021

Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X

Cordis Corporation

FDA Devices Moderate Aug 18, 2021

TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle…

Bard Peripheral Vascular Inc

FDA Devices Moderate Aug 18, 2021

Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags R…

Advance Dx, Inc.

FDA Devices Moderate Aug 18, 2021

Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).

Medline Industries Inc

FDA Devices Moderate Aug 18, 2021

FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127

BioFire Diagnostics, LLC

FDA Devices Moderate Aug 18, 2021

Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325

Biomet, Inc.

FDA Devices Moderate Aug 18, 2021

Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewire Size: G…

Edwards Lifesciences, LLC

FDA Devices Moderate Aug 18, 2021

Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/…

Medline Industries Inc

FDA Devices Moderate Aug 18, 2021

Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number: 11-301302

Biomet, Inc.

FDA Devices Critical Aug 18, 2021

HeartWare HVAD Implant Kit, REF MCS1705PU

Heartware, Inc.

FDA Devices Moderate Aug 18, 2021

Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;

Beckman Coulter Inc.

FDA Devices Moderate Aug 18, 2021

Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number: 11-301322

Biomet, Inc.

FDA Devices Moderate Aug 18, 2021

CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037

Integra LifeSciences Corp.

FDA Devices Moderate Aug 18, 2021

Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical…

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

TruRize Clinical Chair - support structure that places human occupants in upright, seated, recline, supine, and trend positions, Model Number: 3333, …

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (including stages 1, 2, 3, 4, Unst…

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Numb…

Covidien Llc

FDA Devices Moderate Aug 18, 2021

Spectrum Medical Quantum Standard heat exchanger

QURA S.R.L.

FDA Devices Moderate Aug 18, 2021

Prime TC-transport chair intended for medical purposes to assist a person in performing an activity that the person would find difficult to do or be…

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)0…

Edwards Lifesciences, LLC

CPSC Moderate Aug 18, 2021

Hallmark Recalls Teethers Due to Choking Hazard

CPSC Moderate Aug 18, 2021

Intertex Recalls Blower Fans Due to Fire Hazard

Intertex LLC, of West Chester, Pa.

CPSC Moderate Aug 18, 2021

Marin Mountain Bikes Recalls Bicycles Due to Fall and Crash Hazards

CPSC Moderate Aug 18, 2021

Nordstrom Recalls Children's Socks Due to Choking Hazard

CPSC Moderate Aug 18, 2021

Primark Recalls Scent Stamper Pens Due to Elevated Levels of Benzyl Alcohol; Risk of Skin Irritation

CPSC Moderate Aug 18, 2021

Ravin Crossbows Reannounces Recall of White Arrow Nocks Due to Injury Hazard and Additional Incidents; Nearly Two Dozen Serious Injuries Reported

Ravin Crossbows LLC, of Superior, Wis.

CPSC Moderate Aug 18, 2021

TJX Recalls Counter Stools Due to Fall and Injury Hazards; Sold at HomeGoods and Homesense Stores

NHTSA Critical Aug 18, 2021

BENTLEY 2021: ELECTRONIC STABILITY CONTROL (ESC):CONTROL MODULE:SOFTWARE

BENTLEY

NHTSA Critical Aug 18, 2021

BMW 2022: EQUIPMENT:OTHER:LABELS

BMW

CPSC Moderate Aug 17, 2021

Zen Magnets and Neoballs Magnets Recalled Due to Ingestion Hazard

Zen Magnets LLC, of Denver, Colorado

NHTSA Critical Aug 13, 2021

MERCEDES-BENZ 2011-2015: AIR BAGS:FRONTAL

MERCEDES-BENZ

CPSC Moderate Aug 12, 2021

Area Rugs Recalled Due to Violation of Federal Flammability Standard and Fire Hazard; Imported by Pacapet; Sold Exclusively on Amazon.com (Recall Ale…

CPSC Moderate Aug 12, 2021

Rossignol Recalls All Track DH Bicycles Due to Fall Hazard (Recall Alert)

CPSC Moderate Aug 12, 2021

Rugs Recalled Due to Violation of Federal Flammability Standard and Fire Hazard; Imported by Suellen Roosevein; Sold Exclusively on Amazon.com (Recal…

CPSC Moderate Aug 12, 2021

Tye Dye Area Rugs Recalled Due to Violation of Federal Flammability Standard and Fire Hazard; Imported by And Beyond; Sold Exclusively on Amazon.com …

NHTSA Critical Aug 12, 2021

LAND ROVER 2010-2016: FUEL SYSTEM, GASOLINE:DELIVERY:FUEL PUMP:MOUNTING PLATE/FLANGE

LAND ROVER

NHTSA Critical Aug 12, 2021

BUICK,CHEVROLET 2013: SUSPENSION:REAR

BUICK,CHEVROLET

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 - consumer product and vehicle recall feeds for 2021

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Figures cover calendar year 2021 across the FDA, CPSC 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 July 2026.