PlainRecalls

2021 Recalls

5,086 recalls · Page 89 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 11 critical, 38 moderate, and 1 lower-severity recalls. The page references 23 distinct recalling firms operating in 7 distinct product categories, with 48 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (26), FDA Drug (10), FDA Food (8), 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 Food Moderate Feb 24, 2021

20 Mile Holiday EggNog, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48815. Made by Barron County Organics, LLC,…

Barron County Organics

FDA Food Moderate Feb 24, 2021

20 Mile Raspberry, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48812. Made by Barron County Organics, LLC, 10-M…

Barron County Organics

FDA Food Moderate Feb 24, 2021

20 Mile Cookies-N-Cream, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48802. Made by Barron County Organics, LLC…

Barron County Organics

FDA Food Moderate Feb 24, 2021

20 Mile Strawberry, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48813. Made by Barron County Organics, LLC, 10-…

Barron County Organics

FDA Food Moderate Feb 24, 2021

20 Mile Salted Caramel with Cashew Praline, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48800. Made by Barron C…

Barron County Organics

FDA Food Moderate Feb 24, 2021

20 Mile Coffee, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48806. Made by Barron County Organics, LLC, 10-Mile…

Barron County Organics

FDA Food Moderate Feb 24, 2021

20 Mile Pumpkin Spice, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48814. Made by Barron County Organics, LLC, …

Barron County Organics

FDA Food Moderate Feb 24, 2021

20 Mile Coconut, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48810. Made by Barron County Organics, LLC, 10-Mil…

Barron County Organics

FDA Drug Moderate Feb 24, 2021

Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC…

Wilshire Pharmaceuticals Inc

FDA Drug Moderate Feb 24, 2021

Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ Fabricado por: De La Cruz Products, A Division of DLC Laboratories, Inc. …

DLC Laboratories, Inc

FDA Drug Low Feb 24, 2021

Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., 245 Firs…

Akebia Therapeutics dba Keryx Biopharmaceutials, Inc

FDA Drug Moderate Feb 24, 2021

Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Dis…

Ascend Laboratories LLC

FDA Drug Moderate Feb 24, 2021

Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Dist…

Ascend Laboratories LLC

FDA Drug Critical Feb 24, 2021

OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 8.5 Fl. Oz. (250 mL) bottle, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. …

Liq-E S.A. De C.V.

FDA Drug Critical Feb 24, 2021

OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 55 Gal (208 L) drum, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col.. L…

Liq-E S.A. De C.V.

FDA Drug Critical Feb 24, 2021

OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 1 Gal (3.78 L) bottle, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col…

Liq-E S.A. De C.V.

FDA Drug Critical Feb 24, 2021

OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 275 Gal (1040 L) tank with spout dispenser, Made in Mexico, Liq-E, S.A. DE C.V., Puerto …

Liq-E S.A. De C.V.

FDA Drug Moderate Feb 24, 2021

Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 5…

Wilshire Pharmaceuticals Inc

FDA Devices Critical Feb 24, 2021

Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed…

Combat Medical Systems, LLC

FDA Devices Moderate Feb 24, 2021

Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer disinfector intended for washing, disinfecting and drying of surgical…

Getinge Group Logistics America, LLC

FDA Devices Moderate Feb 24, 2021

Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hemodialysis tr…

Baxter Healthcare Corporation

FDA Devices Moderate Feb 24, 2021

AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplie…

Sky Medical Supplies and Equipments LLC

FDA Devices Critical Feb 24, 2021

Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB Collection Set includes the item…

Combat Medical Systems, LLC

FDA Devices Moderate Feb 24, 2021

System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.

GE Healthcare, LLC

FDA Devices Moderate Feb 24, 2021

Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289 - Product Usage: intended for single use in a hemodialysis tr…

Baxter Healthcare Corporation

FDA Devices Moderate Feb 24, 2021

IOLMaster 700

Carl Zeiss Meditec AG

FDA Devices Moderate Feb 24, 2021

Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA N…

Medtronic Neurosurgery

FDA Devices Moderate Feb 24, 2021

Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 22011…

Medtronic Neurosurgery

FDA Devices Moderate Feb 24, 2021

LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Cata…

LumiraDx

FDA Devices Moderate Feb 24, 2021

Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dia…

Baxter Healthcare Corporation

FDA Devices Moderate Feb 24, 2021

Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - Product Usage: intended for single use in a hemo…

Baxter Healthcare Corporation

FDA Devices Moderate Feb 24, 2021

Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435 - Product Usage: intended for single us…

Baxter Healthcare Corporation

FDA Devices Moderate Feb 24, 2021

SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxi…

SenTec AG

FDA Devices Moderate Feb 24, 2021

Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL 0.5, 24053 …

Medtronic Neurosurgery

FDA Devices Moderate Feb 24, 2021

Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment using the Pho…

Baxter Healthcare Corporation

FDA Devices Critical Feb 24, 2021

Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience kit. The Fresh Whole Blood Transfusion Set contains everythi…

Combat Medical Systems, LLC

FDA Devices Moderate Feb 24, 2021

13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and …

Cairn Diagnostics

FDA Devices Moderate Feb 24, 2021

System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition

GE Healthcare, LLC

FDA Devices Critical Feb 24, 2021

Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit. The Valkyrie LTOWB Administration Set contains the items ne…

Combat Medical Systems, LLC

FDA Devices Moderate Feb 24, 2021

Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a - Product Usage: is a lateral flow immunoassay intended for th…

Confirm Biosciences Inc

FDA Devices Critical Feb 24, 2021

Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to ad…

Combat Medical Systems, LLC

FDA Devices Moderate Feb 24, 2021

Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.

Biomet, Inc.

FDA Devices Moderate Feb 24, 2021

Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCCOV-402a - Product Usage: is a lateral flow immunoassay intended…

Confirm Biosciences Inc

FDA Devices Moderate Feb 24, 2021

BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482

Becton Dickinson & Company

CPSC Moderate Feb 24, 2021

Northern Tool & Equipment Recalls Powerhorse Portable Generators Due to Shock Hazard

CPSC Moderate Feb 24, 2021

Potter Electric Recalls Addressable Pull Stations Single/Dual Action Due to Failure to Alert to Fire

Potter Electric Signal Company, LLC, of St. Louis, Mo.

CPSC Moderate Feb 24, 2021

SmartPool Recalls Children's Multi-Purpose Helmets Due to Risk of Head Injury

Shenzhen Haochen Industrial Co. Ltd., of China

CPSC Moderate Feb 24, 2021

Urban Outfitters Recalls Margo Taper Candle Holders Due to Fire Hazard

NHTSA Critical Feb 24, 2021

INTERNATIONAL 2021: ENGINE

INTERNATIONAL

NHTSA Critical Feb 24, 2021

AUDI 2019-2021: ENGINE AND ENGINE COOLING:ENGINE:ENGINE CONTROL MODULE (ECU/ECM)

AUDI

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