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 19 distinct recalling firms operating in 4 distinct product categories, with 47 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (45), NHTSA (3), CPSC (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 Dec 1, 2021

Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), Restore Ultra SureScan MRI (Model 97712), and RestoreSensor SureScan MRI (Model 97714) implantable neurostimulators.

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 Number: 10848354

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 ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETCF2828C49E

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 Number: 10848280

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 the Patient Cart (PC). The Patient Cart is the operative component of the system and its primary function is to support the instrument arms and camera arm. The X/Xi Instrument Arm Drape is intended to be used with the instrument arms of the PC as a sterile barrier during clinical procedures, and makes the instrument arms sterile and suitable for s

Intuitive Surgical, Inc.

FDA Devices Moderate Dec 1, 2021

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

Medtronic Vascular, Inc.

FDA Devices Moderate Dec 1, 2021

Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Dec 1, 2021

Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Dec 1, 2021

Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Dec 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Number: 882410 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.

Philips North America Llc

FDA Devices Moderate Dec 1, 2021

ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89

Abbott Laboratories

FDA Devices Moderate Dec 1, 2021

Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600

Western/Scott Fetzer Company

FDA Devices Moderate Dec 1, 2021

SOMATOM Definition AS with software syngo.CT VB20 Model #8098027

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Dec 1, 2021

Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.

Medtronic Neuromodulation

FDA Devices Moderate Dec 1, 2021

Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10848355

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Dec 1, 2021

The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from entering into the pleural space and a suction control chamber, which incorporates a mechanical regulator to control suction pressures imposed upon the patient's pleural cavity.

Atrium Medical Corporation

FDA Devices Moderate Dec 1, 2021

Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094141

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Dec 1, 2021

Cardioblate CryoFlex Surgical Ablation Console

Medtronic Perfusion Systems

FDA Devices Moderate Dec 1, 2021

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate Dec 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.

Philips North America Llc

FDA Devices Moderate Dec 1, 2021

SOMATOM Force with software syngo.CT VB20 Model #10742326

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Dec 1, 2021

Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840

Western/Scott Fetzer Company

FDA Devices Moderate Dec 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.

Philips North America Llc

FDA Devices Moderate Dec 1, 2021

SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Dec 1, 2021

CombiDiagnost R90 is multi-functional general R/F systems.

Philips Healthcare

FDA Devices Moderate Dec 1, 2021

ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77;

Abbott Laboratories

FDA Devices Moderate Dec 1, 2021

SOMATOM Confidence with software syngo.CT VB20 Model #10590100

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Dec 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.

Philips North America Llc

FDA Devices Moderate Dec 1, 2021

Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Dec 1, 2021

DigitalDiagnost C90

Philips Healthcare

FDA Devices Moderate Dec 1, 2021

SOMATOM Drive with software syngo.CT VB20 Model #10431700

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Dec 1, 2021

Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.

Medtronic Neuromodulation

FDA Devices Moderate Dec 1, 2021

Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)

Philips Healthcare

FDA Devices Moderate Dec 1, 2021

SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Dec 1, 2021

Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

GE Healthcare, LLC

FDA Devices Moderate Dec 1, 2021

ProxiDiagnost N90 is multi-functional general R/F systems.

Philips Healthcare

FDA Devices Moderate Dec 1, 2021

Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848353

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Dec 1, 2021

BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/hr)-0.5mL, REF 383536; BD Q-Style Luer Access Split Septum BD Vialon Material; BD Instaflash Needle Technology; Rx Only, Sterile EO. BD Nexiva closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon" catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, dual port adapte

Becton Dickinson Infusion Therapy Systems Inc.

FDA Devices Moderate Dec 1, 2021

Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESB

Medtronic Vascular, Inc.

FDA Devices Moderate Dec 1, 2021

Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094139

Siemens Medical Solutions USA, Inc

CPSC No agency class Dec 1, 2021

E-filliate Recalls DEWALT Wireless Earphones Due to Burn and Fire Hazards

CPSC No agency class Dec 1, 2021

Halo Recalls Promotional Children's Projector Flashlights Due to Button Battery Ingestion and Choking Hazards

Starlight Children's Foundation, of Culver City, California

NHTSA No agency class Dec 1, 2021

KIA 2020-2021: SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS:MASTER CYLINDER

KIA

NHTSA No agency class Dec 1, 2021

AUDI 2022: SUSPENSION:FRONT

AUDI

NHTSA No agency class Dec 1, 2021

MERCEDES-BENZ 2021: STRUCTURE

MERCEDES-BENZ

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.