PlainRecalls

2021 Recalls

5,168 recalls · Page 71 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 13 critical, 36 moderate, and 1 lower-severity recalls. The page references 20 distinct recalling firms operating in 5 distinct product categories, with 21 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (39), NHTSA (8), CPSC (3), 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 May 19, 2021

Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on t…

Meridian Bioscience Inc

FDA Devices Moderate May 19, 2021

PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 00801741027192 …

Bard Peripheral Vascular Inc

FDA Devices Moderate May 19, 2021

REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage: provides a…

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros , Bag Hanger, Drop-In Red Cap…

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular s…

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.

Atos Medical AB

FDA Devices Moderate May 19, 2021

REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. FLUSSO, BCV, Y-Clave - Product Usage: provides access for the administrat…

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351

Randox Laboratories Ltd.

FDA Devices Moderate May 19, 2021

NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000

Abbott Laboratories Inc. (St Jude Medical)

FDA Devices Moderate May 19, 2021

Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.

Haag-Streit USA Inc

FDA Devices Moderate May 19, 2021

REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides access for the administration …

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PORT, BCV, Spiros - Product Usage: provides access for the administration …

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Drip Chamber, Clave", Spiros" w/Red Cap, Bag Hanger - Product Usage: provi…

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros¿ Closed Male Luer, Purple Cap - Product Usage: provides a…

ICU Medical, Inc.

FDA Devices Critical May 19, 2021

Kit: Blood Culture. MAI Kit Part Number: 80315D

Medical Action Industries, Inc. 306

FDA Devices Moderate May 19, 2021

REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provid…

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger - Product Usage: provides acces…

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" - Product Usage: provides access for the administration of fluids from a …

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros" - Product Usage: provides access for the administration of f…

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remove organic and inorganic sub…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate May 19, 2021

NM/CT 870 DR Nuclear Medicine / CT Scanners

GE Healthcare, LLC

FDA Devices Moderate May 19, 2021

Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening metho…

Remel Inc

FDA Devices Critical May 19, 2021

Kit: Midline Insertion DA. MAI Kit Part Number: 77981B

Medical Action Industries, Inc. 306

FDA Devices Moderate May 19, 2021

Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software ver…

Meridian Bioscience Inc

FDA Devices Moderate May 19, 2021

PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)00801741027406 -…

Bard Peripheral Vascular Inc

FDA Devices Moderate May 19, 2021

REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patie…

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vasc…

ICU Medical, Inc.

FDA Devices Critical May 19, 2021

Kit: Injection REVIEW MAI Kit Part Number: 74736

Medical Action Industries, Inc. 306

FDA Devices Moderate May 19, 2021

REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps - Product Usage: prov…

ICU Medical, Inc.

FDA Devices Low May 19, 2021

VenaSeal Closure System

Medtronic Inc.

FDA Devices Moderate May 19, 2021

REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer - P…

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects or osseous defects created from traumatic…

Musculoskeletal Transplant Foundation, Inc.

FDA Devices Moderate May 19, 2021

REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vascular syst…

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Product Usage: provides access for the administration of fluids from a con…

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access for the administration of fluids from a container to a patient s vascul…

ICU Medical, Inc.

FDA Devices Moderate May 19, 2021

NM/CT 850 Nuclear Medicine / CT Scanners

GE Healthcare, LLC

FDA Devices Moderate May 19, 2021

REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s …

ICU Medical, Inc.

FDA Devices Critical May 19, 2021

Kit: Blood Culture MAI Kit Part Number: 80076

Medical Action Industries, Inc. 306

FDA Devices Critical May 19, 2021

ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or du…

St. Jude Medical, Cardian Rhythm Management Division

CPSC Moderate May 19, 2021

Cheyenne Products Recalls Folding Chairs and Barstools Due to Fall Hazard

CPSC Moderate May 19, 2021

IKEA Recalls Bowls, Plates, and Mugs Due to Burn Hazard

NHTSA Critical May 19, 2021

FREIGHTLINER,WESTERN STAR 2021-2022: STEERING:LINKAGES:TIE ROD ASSEMBLY

FREIGHTLINER,WESTERN STAR

NHTSA Critical May 19, 2021

INTERNATIONAL 2019-2021: FUEL SYSTEM, DIESEL:FUEL INJECTION SYSTEM:FUEL RAIL

INTERNATIONAL

NHTSA Critical May 17, 2021

PORSCHE 2021: SUSPENSION:FRONT

PORSCHE

NHTSA Critical May 17, 2021

MERCEDES-BENZ 2019: ELECTRONIC STABILITY CONTROL (ESC):CONTROL MODULE:SOFTWARE

MERCEDES-BENZ

NHTSA Critical May 17, 2021

MERCEDES-BENZ 2020: STRUCTURE:BODY:DOOR:HINGE AND ATTACHMENTS

MERCEDES-BENZ

NHTSA Critical May 14, 2021

FREIGHTLINER 2017-2022: EXTERIOR LIGHTING:HEADLIGHTS:BULBS

FREIGHTLINER

NHTSA Critical May 14, 2021

MERCEDES-BENZ 2019-2021: BACK OVER PREVENTION: SENSING SYSTEM: CAMERA

MERCEDES-BENZ

NHTSA Critical May 14, 2021

MERCEDES-BENZ 2019-2021: LATCHES/LOCKS/LINKAGES:DOORS:LATCH

MERCEDES-BENZ

CPSC Moderate May 13, 2021

Alliance Chemical Recalls Sodium Hydroxide Products Due to Failure to Meet Child Resistant Packaging Requirement and Violation of FHSA Labeling (Reca…

Alliance Chemical, of Taylor, Texas

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 August 2026.