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 15 critical, 35 moderate, and 0 lower-severity recalls. The page references 31 distinct recalling firms operating in 8 distinct product categories, with 37 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (20), FDA Food (14), NHTSA (12), 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 Jun 2, 2021

IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.

Philips North America Llc

FDA Devices Moderate Jun 2, 2021

Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.

Dentech Corp.

FDA Devices Moderate Jun 2, 2021

BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111143

Philips Respironics, Inc.

FDA Devices Moderate Jun 2, 2021

IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems.

Roche Diagnostics Operations, Inc.

FDA Devices Moderate Jun 2, 2021

Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED34-i10T2.

Pentax of America Inc

FDA Devices Moderate Jun 2, 2021

BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: 1111177

Philips Respironics, Inc.

FDA Devices Moderate Jun 2, 2021

Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma using the ADVIA Centaur XP/XPT System and ADVIA Centaur CP Systems, SMN:10492493

Siemens Healthcare Diagnostics, Inc

FDA Devices Moderate Jun 2, 2021

The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2

CooperSurgical, Inc.

FDA Devices Moderate Jun 2, 2021

PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler product line for collection of arterial samples for pH, blood gas, oximetry, electrolyte and metabolite analysis. Model Number/Product Description: 956-518 PICO70 w/o needle; 956-519 PICO70 w/o needle; 956-522 PICO70 22G x 25 mm; 956-525 PICO70 22G x 32 mm; 956-529 PICO70 23G x 16 mm; 956-533 PICO70 23G x 25 mm; 956-534 PICO70 23G x 32 mm; 956-547 PICO70 25G x 16 mm;

Radiometer Medical ApS

FDA Devices Moderate Jun 2, 2021

BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111169

Philips Respironics, Inc.

FDA Devices Moderate Jun 2, 2021

BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169

Philips Respironics, Inc.

FDA Devices Moderate Jun 2, 2021

MyWay Walker Chassis - Product Usage: is intended for use by children already using a supportive walking device.

James Leckey Design Ltd

FDA Devices Moderate Jun 2, 2021

Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

Baxter Healthcare Corporation

FDA Devices Moderate Jun 2, 2021

NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77352

Nobel Biocare Procera LLC

FDA Devices Moderate Jun 2, 2021

GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall Transformer is intended for use in ambulatory and acute care settings.

Welch Allyn Inc

FDA Devices Moderate Jun 2, 2021

NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77387

Nobel Biocare Procera LLC

FDA Devices Moderate Jun 2, 2021

VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDCs formulation of VTM.

Ortho-Clinical Diagnostics, INc.

FDA Devices Moderate Jun 2, 2021

BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178

Philips Respironics, Inc.

FDA Devices Moderate Jun 2, 2021

ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Model: 34XFHT-B Intended: ProBP 3400 automatically measures systolic and diastolic pressure (excluding neonates) and pulse rate, as well as calculates Mean Arterial Pressure (MAP).

Welch Allyn Inc

FDA Devices Moderate Jun 2, 2021

NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics Material Number: 77339

Nobel Biocare Procera LLC

NHTSA No agency class Jun 2, 2021

INFINITI 2017: STEERING

INFINITI

NHTSA No agency class Jun 2, 2021

VOLVO 2021-2022: WHEELS:HUB

VOLVO

NHTSA No agency class Jun 2, 2021

MACK 2021-2022: WHEELS

MACK

NHTSA No agency class Jun 2, 2021

VOLVO 2019-2020: ELECTRICAL SYSTEM:WIRING:FUSES AND CIRCUIT BREAKERS

VOLVO

NHTSA No agency class Jun 2, 2021

VOLKSWAGEN 2021: EXTERIOR LIGHTING:HEADLIGHTS

VOLKSWAGEN

NHTSA No agency class Jun 2, 2021

FREIGHTLINER,MERCEDES-BENZ 2019-2021: ELECTRICAL SYSTEM:SOFTWARE

FREIGHTLINER,MERCEDES-BENZ

NHTSA No agency class Jun 2, 2021

FREIGHTLINER,MERCEDES-BENZ 2019-2021: ELECTRICAL SYSTEM

FREIGHTLINER,MERCEDES-BENZ

USDA FSIS Moderate Jun 2, 2021

FSIS Issues Public Health Alert for Frozen Raw Breaded Stuffed Chicken Products Due to Possible Salmonella Contamination

NHTSA No agency class May 29, 2021

FORD 2021: STEERING:GEAR BOX (OTHER THAN RACK AND PINION)

FORD

NHTSA No agency class May 28, 2021

MERCEDES-BENZ 2021: SEATS:MID/REAR ASSEMBLY:HEAD RESTRAINT

MERCEDES-BENZ

USDA FSIS Critical May 28, 2021

King's Command Foods, LLC. Recalls Meat and Poultry Meatballs and Pork Pattie Products Due to Misbranding and Undeclared Allergens

King's Command Foods, LLC

CPSC No agency class May 27, 2021

Pool and Patio Umbrellas Recalled Due to Injury Hazard (Recall Alert)

Umbrosa NV, of Belgium

CPSC No agency class May 27, 2021

Williams Advanced Materials & Chemicals Recalls Three Chemical Products Due to Failure to Meet Child-Resistant Packaging Requirement and Violation of FHSA Labeling Requirement (Recall Alert)

Williams Advanced Materials & Chemicals Inc., of Clairton, Pa.

NHTSA No agency class May 27, 2021

INFINITI,NISSAN 2020-2021: SUSPENSION:REAR:AXLE:SPINDLE

INFINITI,NISSAN

NHTSA No agency class May 27, 2021

BMW 2000-2001: AIR BAGS:FRONTAL:DRIVER SIDE:INFLATOR MODULE

BMW

NHTSA No agency class May 27, 2021

RAM 2013-2021: WHEELS:LUGS/NUTS/BOLTS/STUDS

RAM

FDA Food Moderate May 26, 2021

Newly Weds B70731 bread crumbs X1, 25lbs bag

Newly Weds Foods Inc

FDA Food Moderate May 26, 2021

Newly Weds B70709 breader crumbs X3, 40lbs bag

Newly Weds Foods Inc

FDA Food Moderate May 26, 2021

Newly Weds B70858 bread crumbs X1, 40lbs bag

Newly Weds Foods Inc

FDA Food Moderate May 26, 2021

Udi Gluten Free Banana Chocolate Chip Muffins, 10oz retail container of 4 muffins, 6 retail units per wholesale case. Retail unit UPC: 00-6-98997-81012-4

CONAGRA BRANDS

FDA Food Critical May 26, 2021

ISOMORPH 28 PURE WHEY iSOLATE COOKIES N CREAM DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89836 8 & 5lb, UPC 6 49241 87832 5 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071

Hi Tech Pharmaceuticals

FDA Food Moderate May 26, 2021

Newly Weds B7AAJ5 bread crumbs X1, 35lbs bag

Newly Weds Foods Inc

FDA Food Moderate May 26, 2021

Waah Organic Rajma Masala

Agri Exim INC.

FDA Food Critical May 26, 2021

Hi Tech Pharmaceuticals

FDA Food Critical May 26, 2021

ISOMORPH 28 PURE WHEY iSOLATE CHOCOLATE MILKSHAKE DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89876 4 & 5lb, UPC 6 49241 87830 8 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071

Hi Tech Pharmaceuticals

FDA Food Moderate May 26, 2021

Newly Weds B52792 breader X1, 35lbs bag

Newly Weds Foods Inc

FDA Food Moderate May 26, 2021

Newly Weds B72377 bread crumbs, 40lbs bag

Newly Weds Foods Inc

FDA Food Moderate May 26, 2021

"Bloomy*** Biotin Collagen Keratin***Capsules for SKIN, JOINT, HAIR***Supplement Facts***Marine Collagen***Manufactured for Bloommy Inc. 106 W. Broad St. Pawcatuck, CT 06379"

bloommy Inc.

FDA Food Moderate May 26, 2021

Newly Weds B70819 bread crumbs, 20lbs bag

Newly Weds Foods Inc

FDA Food Moderate May 26, 2021

Newly Weds A70088 bread crumbs X1, 35lbs bag

Newly Weds 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 September 2026.