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 3 critical, 47 moderate, and 0 lower-severity recalls. The page references 20 distinct recalling firms operating in 4 distinct product categories, with 49 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (44), CPSC (5), NHTSA (1), 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 Oct 27, 2021

MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (01)00840001405868

Implant Resource Inc

FDA Devices Moderate Oct 27, 2021

Foundation Kit

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Oct 27, 2021

REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852

Limacorporate S.p.A

FDA Devices Moderate Oct 27, 2021

Optima MR450w 1.5T nuclear magnetic resonance imaging system

GE Healthcare, LLC

FDA Devices Moderate Oct 27, 2021

1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system

GE Healthcare, LLC

FDA Devices Moderate Oct 27, 2021

Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745

ADRIA SRL

FDA Devices Moderate Oct 27, 2021

Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable Length 15/16" -1-7/8") (24mm-48mm) sterile, For Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion. Original Jamshidi" Bone Marrow Biopsy/Aspiration Needle: - also referred to as Jamshidi needle Intended use for the posterior iliac crest biopsy technique

Bard Peripheral Vascular Inc

FDA Devices Moderate Oct 27, 2021

smiths medical portex Loss of Resistance Device, REF 100/398/000

Smiths Medical ASD Inc.

FDA Devices Moderate Oct 27, 2021

IUD Insertion Pack

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Oct 27, 2021

6.5MMX165MM CANNULATED SCREW

Smith & Nephew, Inc.

FDA Devices Moderate Oct 27, 2021

Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion Intended use to aspirate marrow from either the sternum or the iliac crest. Intraosseous Infusion is recommended only in life-threatening emergencies where vascular access is critical and conventional forms of access are not available or are unobtainable.

Bard Peripheral Vascular Inc

FDA Devices Moderate Oct 27, 2021

SIGNA Architect nuclear magnetic resonance imaging system

GE Healthcare, LLC

FDA Devices Moderate Oct 27, 2021

IUD Insertion Kit

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Oct 27, 2021

Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)

Kinsman Enterprises Inc

FDA Devices Critical Oct 27, 2021

Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers. 1. Cardiosave Hybrid. Model Numbers: 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, 0998-UC-0800-55. 2. Cardiosave Rescue. Model Number: 0998-00-0800-83.

Datascope Corp.

FDA Devices Moderate Oct 27, 2021

Atellica IM 1600 Analyzer, SMN 11066000

Siemens Healthcare Diagnostics, Inc

FDA Devices Moderate Oct 27, 2021

SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system

GE Healthcare, LLC

FDA Devices Moderate Oct 27, 2021

Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749

ADRIA SRL

FDA Devices Moderate Oct 27, 2021

Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A

Canon Medical System, USA, INC.

FDA Devices Moderate Oct 27, 2021

Discovery MR750w 3.0T nuclear magnetic resonance imaging system

GE Healthcare, LLC

FDA Devices Moderate Oct 27, 2021

EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232

Philips Ultrasound Inc

FDA Devices Moderate Oct 27, 2021

SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051

DiaSorin Molecular LLC

FDA Devices Moderate Oct 27, 2021

medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g. 089-101E h. 888-101NE i. 081-102GEE j. 888-101BE k. 888-101GE l. 888-101GEE m. 081-101RE n. 081-102GE o. 081-102BE p. 888-101RE

Smiths Medical ASD Inc.

FDA Devices Moderate Oct 27, 2021

SIGNA Voyager nuclear magnetic resonance imaging system

GE Healthcare, LLC

FDA Devices Moderate Oct 27, 2021

Kit: Central Line Dres Change 20/Cs

Medical Action Industries, Inc. 306

FDA Devices Moderate Oct 27, 2021

SIGNA Artist nuclear magnetic resonance imaging system

GE Healthcare, LLC

FDA Devices Moderate Oct 27, 2021

Discovery MR750 3.0T nuclear magnetic resonance imaging system

GE Healthcare, LLC

FDA Devices Moderate Oct 27, 2021

Tenaculum, Plastic

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Oct 27, 2021

Atellica IM 1300 Analyzer, SMN 11066001

Siemens Healthcare Diagnostics, Inc

FDA Devices Moderate Oct 27, 2021

Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 40A2500, Nucleus Removal Angled Blade, 25 cm x 4.0 mm; (2) REF 40R2000, Nucleus Removal Set, 20 cm x 4.0 mm; (3) REF 40R2500, Nucleus Removal Set, 25 cm x 4.0 mm; (4) REF 40S2000, Nucleus Removal Straight Blade, 20 cm x 4.0 mm; (5) REF 40S2500, Nucleus Removal Straight Bla

Medtronic Xomed, Inc.

FDA Devices Moderate Oct 27, 2021

HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/Elite Pro) Part Number: 0020302601

Instrumentation Laboratory

FDA Devices Moderate Oct 27, 2021

Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1883080EM, Rotatable Fusion Blade, Quadcut 3.0 mm x 13 cm; (2) REF 1883480EM, Rotatable Fusion Blade, Quadcut, 3.4 mm x 13 cm; (3) REF 1884006EM, Rotatable Fusion Blade, RAD 40; (4) REF 1884012EM, Rotatable Fusion Blade, RAD 12; (5) REF 1884080EM, Rotatable Fusion Blade, T

Medtronic Xomed, Inc.

FDA Devices Moderate Oct 27, 2021

REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845

Limacorporate S.p.A

FDA Devices Moderate Oct 27, 2021

Endometrial Biopsy Kit

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Oct 27, 2021

Standard IUD Insertion Kit

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Oct 27, 2021

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator for the determination of IgG antibodies to SARS-CoV-2. Product Code: 6199

Ortho Clinical Diagnostics Inc

FDA Devices Moderate Oct 27, 2021

HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602

Instrumentation Laboratory

FDA Devices Moderate Oct 27, 2021

SIGNA Premier nuclear magnetic resonance imaging system

GE Healthcare, LLC

FDA Devices Moderate Oct 27, 2021

Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1882916, RAD 60 Sinus Blade, 11 cm x 2.9 mm; (2) REF 1883514, RAD 12 Curved Sinus Blade, 11 cm x 3.5 mm; (3) REF 1884013, Powered Tonsillectomy Blade, 11 cm x 4 mm; (4) REF 1884020, Tricut Laryngeal Blade, 22.5 cm x 4 mm; (5) REF 1884032, Tracheal Blade, 37 cm x 4 mm; (6)

Medtronic Xomed, Inc.

FDA Devices Moderate Oct 27, 2021

P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641

Fort Defiance Industries, LLC

FDA Devices Critical Oct 27, 2021

CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L

Smiths Medical ASD Inc.

FDA Devices Moderate Oct 27, 2021

CADD Administration Sets, Model #21-7346-24

Smiths Medical ASD Inc.

FDA Devices Moderate Oct 27, 2021

Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715

ADRIA SRL

FDA Devices Moderate Oct 27, 2021

HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACL TOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/Elite Pro/8/9/10000) Part Number: 0020302600

Instrumentation Laboratory

CPSC No agency class Oct 27, 2021

5.11 Recalls Tactec Plate Carriers Due to Injury Hazard

CPSC No agency class Oct 27, 2021

Liberty Hardware Recalls Glass Cabinet Knobs Due to Laceration Hazard

CPSC No agency class Oct 27, 2021

Magnussen Home Recalls Nova Series 5-Drawer Chests Due to Tip-Over and Entrapment Hazards

CPSC No agency class Oct 27, 2021

Meridian Furniture Recalls Ottomans Due to Laceration Hazard

CPSC No agency class Oct 27, 2021

myCharge Recalls Powerbanks Due to Fire and Burn Hazards

NHTSA No agency class Oct 27, 2021

HYUNDAI 2021: SERVICE BRAKES, HYDRAULIC:FLUID

HYUNDAI

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.