PlainRecalls

2021 Recalls

Compiled from official public sources by the editorial team.

5,168 recalls · Page 2 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 6 critical, 43 moderate, and 1 lower-severity recalls. The page references 32 distinct recalling firms operating in 6 distinct product categories, with 45 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (27), FDA Drug (8), 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 Drug Moderate Dec 29, 2021

Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166 UPC 0 00856…

Efficient Laboratories, Inc.

FDA Drug Moderate Dec 29, 2021

Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NDC 00093-4125-74) (when mixed…

Teva Pharmaceuticals USA

FDA Drug Moderate Dec 29, 2021

Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC 53329-970-08; and c) 16 Oz. (…

Medline Industries Inc

FDA Drug Moderate Dec 29, 2021

Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livo…

The Harvard Drug Group

FDA Drug Moderate Dec 29, 2021

Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 8011…

Denver Solutions, LLC DBA Leiters Health

FDA Drug Moderate Dec 29, 2021

Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58593-829-04 and b) 6 Fl. Oz. (178 mL) bottles NDC 58593-829-06, Distribut…

Efficient Laboratories, Inc.

FDA Drug Moderate Dec 29, 2021

Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-235-…

Efficient Laboratories, Inc.

FDA Drug Moderate Dec 29, 2021

Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-275-06

Efficient Laboratories, Inc.

FDA Devices Moderate Dec 29, 2021

Torosa Saline-Filled Testicular Prosthesis (Size Small)

Coloplast Manufacturing US, LLC

FDA Devices Moderate Dec 29, 2021

These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0 *Produ…

Hill-Rom Inc.

FDA Devices Moderate Dec 29, 2021

VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX

Civco Medical Instruments Co. Inc.

FDA Devices Moderate Dec 29, 2021

Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 29, 2021

Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884

Beaver Visitec International, Inc.

FDA Devices Moderate Dec 29, 2021

Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.

Wright Medical Technology Inc

FDA Devices Moderate Dec 29, 2021

SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825

Beckman Coulter Inc.

FDA Devices Moderate Dec 29, 2021

Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguid…

Medtronic Navigation, Inc.

FDA Devices Moderate Dec 29, 2021

VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX

Civco Medical Instruments Co. Inc.

FDA Devices Moderate Dec 29, 2021

Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number…

Beaver Visitec International, Inc.

FDA Devices Moderate Dec 29, 2021

Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.

Wright Medical Technology, Inc.

FDA Devices Critical Dec 29, 2021

Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and Stealt…

Medtronic Navigation, Inc.

FDA Devices Moderate Dec 29, 2021

Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890

Maquet Cardiovascular, LLC

FDA Devices Moderate Dec 29, 2021

Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, incl…

Philips North America Llc

FDA Devices Moderate Dec 29, 2021

VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX

Civco Medical Instruments Co. Inc.

FDA Devices Moderate Dec 29, 2021

Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of …

Cook Inc.

FDA Devices Moderate Dec 29, 2021

Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK100/2

Beaver Visitec International, Inc.

FDA Devices Moderate Dec 29, 2021

Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK833/2

Beaver Visitec International, Inc.

FDA Devices Moderate Dec 29, 2021

Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK834/1

Beaver Visitec International, Inc.

FDA Devices Moderate Dec 29, 2021

Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.

Wright Medical Technology Inc

FDA Devices Moderate Dec 29, 2021

TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z

Acclarent, Inc.

FDA Devices Moderate Dec 29, 2021

Leica Microsystems M220 F12 Microscope Systems

Leica Microsystems, Inc.

FDA Devices Moderate Dec 29, 2021

VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX

Civco Medical Instruments Co. Inc.

FDA Devices Moderate Dec 29, 2021

regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.

ROi CPS LLC

FDA Devices Moderate Dec 29, 2021

Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Dec 29, 2021

Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK110/3

Beaver Visitec International, Inc.

FDA Devices Critical Dec 29, 2021

WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6

Cardiovascular Systems Inc

CPSC Moderate Dec 29, 2021

Scott Fetzer Consumer Brands Recalls American Angler Electric Fillet Knives Due to Laceration Hazard

Weihai Yuanji Outdoor Products Co., Ltd. (RTI), of China

NHTSA Critical Dec 29, 2021

KENWORTH,PETERBILT 2016-2022: ELECTRICAL SYSTEM:WIRING

KENWORTH,PETERBILT

NHTSA Critical Dec 28, 2021

HYUNDAI 2020-2021: VISIBILITY:WINDSHIELD

HYUNDAI

NHTSA Critical Dec 28, 2021

HYUNDAI 2022: ELECTRICAL SYSTEM: INSTRUMENT CLUSTER/PANEL

HYUNDAI

NHTSA Moderate Dec 27, 2021

MERCEDES-BENZ 2022: COMMUNICATION: AUTO CRASH NOTIFICATION

MERCEDES-BENZ

CPSC Moderate Dec 23, 2021

Polaris Recalls Recreational Off-Road Vehicles Due to Crash Hazard (Recall Alert)

NHTSA Critical Dec 23, 2021

TOYOTA 2007-2022: STEERING:HYDRAULIC POWER ASSIST SYSTEM

TOYOTA

FDA Food Moderate Dec 22, 2021

Livia One Organic Daily Topical Spray Probiotics; 4 oz. (120 ml) UPC: 0 30915 10710 5 Recommended use: Topical: Spray affected area 2-5 times …

Livia Global

FDA Food Moderate Dec 22, 2021

Kool-Aid cherry drink mix powder 19 oz. UPC 043000953532 19 oz. UPC 043000034163 63 oz. UPC 043000082201

KRAFT HEINZ FOODS COMPANY

FDA Food Moderate Dec 22, 2021

Country Time Lemonade drink mix powder 19 oz. UPC 043000951170 29 oz. UPC 043000951194 63 oz. UPC 043000082195 82.5 oz. UPC 043000928608 116 oz…

KRAFT HEINZ FOODS COMPANY

FDA Food Moderate Dec 22, 2021

Krispy Kreme DOUGHNUT Bites ORIGINAL GLAZED 5 1.6 OZ (45g) POUCHES NET WT. 8 OZ (227g) Manufactured under the authority of Krispy Kreme Doughnut Corp…

KRISPY KREME DOUGHNUT CORPORATIO

FDA Food Moderate Dec 22, 2021

Tang orange drink mix powder 20 oz. UPC 043000032275 58.9 oz. UPC 043000082171 72 oz. UPC 043000032268

KRAFT HEINZ FOODS COMPANY

FDA Food Low Dec 22, 2021

Mother's Milk Bank of North Texas 817-810-0071 Pasteurized Donor Human milk Volume: 100mL 1.00 g/dL Protein packaged in sterile BPA free plastic bott…

MOTHERS MILK BANK OF NORTH TEXAS

FDA Food Moderate Dec 22, 2021

Yeast Extract Ajirex in 15 kg PE bag in carton box

Mitsubishi International Food Ingredients, Inc.

FDA Food Moderate Dec 22, 2021

Tang guava pineapple drink mix powder 18 oz. UPC 043000064511

KRAFT HEINZ FOODS COMPANY

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 July 2026.