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 10 critical, 39 moderate, and 1 lower-severity recalls. The page references 20 distinct recalling firms operating in 6 distinct product categories, with 39 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (36), NHTSA (10), 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 Feb 3, 2021

Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System

K2M, Inc

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and blood intravascular.

Braxton Medical Corporation

FDA Devices Moderate Feb 3, 2021

Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928

OMNIlife science Inc.

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)

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

FDA Devices Moderate Feb 3, 2021

SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-25128

OMNIlife science Inc.

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain (EEG) and other bio-potential signals and to record physiological data required for sleep studies.

Nihon Kohden America Inc

FDA Devices Moderate Feb 3, 2021

BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (region). Catalog No. 408348

Becton Dickinson & Company

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951

Philips North America, LLC

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 453564052441, 453564052451, 453564166851, 453564166861

Philips North America, LLC

FDA Devices Moderate Feb 3, 2021

Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067

Stryker Sustainability Solutions

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Note: U1053617 added 1/29/2021 after noticing

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24728

OMNIlife science Inc.

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Respironics California, LLC

FDA Devices Low Feb 3, 2021

Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein cholesterol (LDL-C) in serum or plasma.

Fujifilm Medical Systems U.S.A., Inc.

FDA Devices Moderate Feb 3, 2021

FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.

Fujifilm Medical Systems U.S.A., Inc.

FDA Devices Moderate Feb 3, 2021

BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (region). Catalog No. 404204

Becton Dickinson & Company

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)

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

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE

Enztec Limited

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Respironics California, LLC

CPSC No agency class Feb 3, 2021

Enerco Group Recalls DeWALT Cordless Kerosene Heaters Due to Fire and Carbon Monoxide Poisoning Hazards

CPSC No agency class Feb 3, 2021

Victory Innovations Recalls Electrostatic Sprayers with Lithium-ion Battery Packs Due to Fire and Explosion Hazards

NHTSA No agency class Feb 3, 2021

BMW 2020-2021: POWER TRAIN:DRIVELINE:DRIVESHAFT

BMW

NHTSA No agency class Feb 3, 2021

LEXUS 2019-2021: FUEL SYSTEM, GASOLINE:STORAGE:TANK ASSEMBLY:FILLER PIPE AND CAP

LEXUS

NHTSA No agency class Feb 3, 2021

FREIGHTLINER,MERCEDES-BENZ 2012-2018: ELECTRONIC STABILITY CONTROL (ESC):CONTROL MODULE

FREIGHTLINER,MERCEDES-BENZ

USDA FSIS Moderate Feb 2, 2021

FSIS Issues Public Health Alert for Raw Ground Beef Product Due to Possible E. Coli O157:H7 Contamination

NHTSA No agency class Feb 1, 2021

VOLKSWAGEN 2021: SEATS

VOLKSWAGEN

NHTSA No agency class Feb 1, 2021

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

RAM

NHTSA No agency class Jan 29, 2021

TESLA 2012-2018: BACK OVER PREVENTION:SOFTWARE

TESLA

NHTSA No agency class Jan 29, 2021

MERCEDES-BENZ 2021: CHILD SEAT

MERCEDES-BENZ

NHTSA No agency class Jan 29, 2021

MERCEDES-BENZ 2017-2021: SEAT BELTS:FRONT:RETRACTOR

MERCEDES-BENZ

NHTSA No agency class Jan 29, 2021

BMW 2021: STEERING:COLUMN

BMW

NHTSA No agency class Jan 28, 2021

JEEP 2018-2021: POWER TRAIN:CLUTCH ASSEMBLY

JEEP

FDA Food Critical Jan 27, 2021

Rhino Foods, 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: 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 November 2026.