PlainRecalls

2021 Recalls

5,086 recalls · Page 96 of 102

2021 Recall Year Insight

Federal agencies issued 5,086 product recalls indexed by PlainRecalls in calendar year 2021. That represents about 6.06% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 13.9 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 102 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 0 critical, 49 moderate, and 1 lower-severity recalls. The page references 15 distinct recalling firms operating in 1 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (50), 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 Moderate Feb 3, 2021

Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommende…

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended…

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-recommended…

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only with various combinations of Respironics-recommended…

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm pl…

Hardy Diagnostics

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics-recommended…

Respironics California, LLC

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…

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system

PHILIPS HOME HEALTHCARE SOLUTION

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-recommended…

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth w…

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

FDA Devices Moderate Feb 3, 2021

EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

Boston Scientific Corporation

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only with various combinations of Respironics-recommended…

Respironics California, LLC

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…

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics-recommended…

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended…

Respironics California, LLC

FDA Devices Moderate Feb 3, 2021

therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRA…

Qiagen Sciences LLC

FDA Devices Moderate Feb 3, 2021

DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)

Neocis, Inc.

FDA Devices Moderate Feb 3, 2021

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

Boston Scientific Corporation

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…

Respironics California, LLC

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…

Respironics California, LLC

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-recommende…

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-recomm…

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-recommend…

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…

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…

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 proced…

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…

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, SureSca…

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 proce…

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-recommende…

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 i…

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 an…

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-recomm…

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…

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…

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-recommende…

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…

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, 453564166…

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…

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-recommend…

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-recomm…

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 proce…

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-recommende…

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…

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-recomm…

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…

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 lipopro…

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 m…

Fujifilm Medical Systems U.S.A., 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: CPSC + NHTSA — consumer product and vehicle recall feeds for 2021