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 7 critical, 42 moderate, and 1 lower-severity recalls. The page references 30 distinct recalling firms operating in 4 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (28), FDA Drug (20), FDA Food (2), 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 Food Critical Sep 1, 2021

Wavy Lay s Original Potato Chips UPC 0 28400 04380 9 packaged in flexible bag

Frito-Lay, Inc. Headquarters

FDA Food Critical Sep 1, 2021

Lidl Preferred Selection-Irish Stout Cheddar - 7 oz.

CAHILLS FARM CHEESE LIMITED

FDA Drug Moderate Sep 1, 2021

FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01

Custopharm, Inc.

FDA Drug Critical Sep 1, 2021

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01

SterRx, LLC

FDA Drug Moderate Sep 1, 2021

PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC (01)00318019000161

Professional Disposables International, Inc

FDA Drug Moderate Sep 1, 2021

PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192.

Professional Disposables International, Inc

FDA Drug Critical Sep 1, 2021

Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-223-21.

KVK-Tech, Inc.

FDA Drug Moderate Sep 1, 2021

PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 USA Reorder No C12400 NDC 10819-3883-3, UPC (01)00310819000154

Professional Disposables International, Inc

FDA Drug Moderate Sep 1, 2021

Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80

Eli Lilly & Company

FDA Drug Moderate Sep 1, 2021

PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S41125 NDC 10819-3885-2, UPC (01)00310819000185

Professional Disposables International, Inc

FDA Drug Low Sep 1, 2021

Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23, 38690 Gosfar, Germany Distributed by Hikma USA Inc. Berkeley Heights, NJ 07922, NDC 0143-9240-01

Hikma Pharmaceuticals USA Inc.

FDA Drug Moderate Sep 1, 2021

Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-037-01

XELLIA PHARMACEUTICALS USA, LLC

FDA Drug Moderate Sep 1, 2021

PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposables International Inc., Orangeburg, NY 10962-1376 Reorder No. B40600; UPC (01)00310819000147, NDC 10819-3883-1,

Professional Disposables International, Inc

FDA Drug Moderate Sep 1, 2021

Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030

HIS ENTERPRISE INC

FDA Drug Moderate Sep 1, 2021

Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4

SigmaPharm Laboratories LLC

FDA Drug Moderate Sep 1, 2021

Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-036-01

XELLIA PHARMACEUTICALS USA, LLC

FDA Drug Moderate Sep 1, 2021

Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.34 fl/oz) Exclusive U.S. Distributor: (Chinese writing)International Nature Nutraceuticals, Inc. New York, NY 10002 www.INNHERB.com. Konzon NDC 51367-008-10

ANHUI WELCOME FOREIGN TRADE CO.,LTD.

FDA Drug Moderate Sep 1, 2021

Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59

Teligent Pharma, Inc.

FDA Drug Moderate Sep 1, 2021

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903

SterRx, LLC

FDA Drug Moderate Sep 1, 2021

PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376, Reorder No S82125, NDC 10819-3891-3, UPC (01)00310819000208.

Professional Disposables International, Inc

FDA Drug Moderate Sep 1, 2021

PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable International, Inc. Orangeburg, NY 10962 -1376 Reorder No S41350 NDC 10819-3885-1, UPC (01)00310819000178.

Professional Disposables International, Inc

FDA Drug Moderate Sep 1, 2021

Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01

RemedyRepack Inc.

FDA Devices Moderate Sep 1, 2021

Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.

Beckman Coulter Inc.

FDA Devices Moderate Sep 1, 2021

OASIS MRI System

Hitachi Healthcare Americas Corporation

FDA Devices Critical Sep 1, 2021

Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.

Cardinal Health

FDA Devices Moderate Sep 1, 2021

ECHELON MRI System

Hitachi Healthcare Americas Corporation

FDA Devices Moderate Sep 1, 2021

Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781358

Philips North America Llc

FDA Devices Critical Sep 1, 2021

Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.

Cardinal Health

FDA Devices Moderate Sep 1, 2021

AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343

BioMimetic Therapeutics, LLC

FDA Devices Moderate Sep 1, 2021

Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001

Roche Diabetes Care, Inc.

FDA Devices Moderate Sep 1, 2021

ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080

DePuy Orthopaedics, Inc.

FDA Devices Moderate Sep 1, 2021

Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781341

Philips North America Llc

FDA Devices Moderate Sep 1, 2021

HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36

Ethicon Endo-Surgery Inc

FDA Devices Moderate Sep 1, 2021

Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489

W. L. Gore & Associates Inc.

FDA Devices Critical Sep 1, 2021

Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.

Cardinal Health

FDA Devices Moderate Sep 1, 2021

Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781277 (OUS)

Philips North America Llc

FDA Devices Moderate Sep 1, 2021

ECHELON Oval MRI System

Hitachi Healthcare Americas Corporation

FDA Devices Moderate Sep 1, 2021

Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001

Roche Diabetes Care, Inc.

FDA Devices Moderate Sep 1, 2021

AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000

Encore Medical, LP

FDA Devices Moderate Sep 1, 2021

Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781315

Philips North America Llc

FDA Devices Moderate Sep 1, 2021

NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-88901

Northeast Scientific Inc.

FDA Devices Moderate Sep 1, 2021

Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781342

Philips North America Llc

FDA Devices Moderate Sep 1, 2021

Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001

Roche Diabetes Care, Inc.

FDA Devices Moderate Sep 1, 2021

Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001

Roche Diabetes Care, Inc.

FDA Devices Moderate Sep 1, 2021

Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number: 66783 and 64219

Oakworks Inc

FDA Devices Moderate Sep 1, 2021

Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Sep 1, 2021

HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20

Ethicon Endo-Surgery Inc

FDA Devices Moderate Sep 1, 2021

BD" Mouse IgG2a Isotype Control APC X39 ASR

Becton, Dickinson and Company, BD Biosciences

FDA Devices Moderate Sep 1, 2021

KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005

Straumann USA LLC

FDA Devices Moderate Sep 1, 2021

AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.

PROCEPT BIOROBOTICS CORPORATION

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.