PlainRecalls

2021 Recalls

5,168 recalls · Page 100 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 4 critical, 43 moderate, and 3 lower-severity recalls. The page references 23 distinct recalling firms operating in 3 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (41), FDA Drug (9), 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 Jan 20, 2021

Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16

Akorn, Inc.

FDA Drug Moderate Jan 20, 2021

Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61, b) 15 mL x 100 Unit Dose Cups…

Precision Dose Inc.

FDA Drug Low Jan 20, 2021

Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx only, US Compounding, 1270 Don's Lane, Conway, AR 72032

US Compounding Inc

FDA Drug Moderate Jan 20, 2021

Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECTION, Edge Ph…

Edge Pharma, LLC

FDA Drug Low Jan 20, 2021

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Case NDC: 64950-354-450(40 unit…

Genus Lifesciences Inc.

FDA Drug Moderate Jan 20, 2021

Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-A ZIP 45410 Tonala, Jalisco, M…

GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION

FDA Drug Moderate Jan 20, 2021

Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by: Universal Distributors LLC, 6197 S. Rur…

GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION

FDA Drug Moderate Jan 20, 2021

Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas C…

Nostrum Laboratories Inc

FDA Drug Low Jan 20, 2021

Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC 107…

KVK-Tech, Inc.

FDA Devices Moderate Jan 20, 2021

Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus

Siemens Medical Solutions USA, Inc

FDA Devices Critical Jan 20, 2021

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714729960904

Boston Scientific Corporation

FDA Devices Moderate Jan 20, 2021

Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Jan 20, 2021

Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functiona…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Jan 20, 2021

Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during transportat…

Steris Corporation

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarb…

Fresenius Medical Care Holdings, Inc.

FDA Devices Critical Jan 20, 2021

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 08714729960911, M…

Boston Scientific Corporation

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarb…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma u…

Ortho Clinical Diagnostics Inc

FDA Devices Moderate Jan 20, 2021

AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 m…

Ansh Labs, LLC

FDA Devices Moderate Jan 20, 2021

CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software U…

Medtronic Inc.

FDA Devices Moderate Jan 20, 2021

GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope …

GE Healthcare, LLC

FDA Devices Moderate Jan 20, 2021

All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, A…

Philips Ultrasound Inc

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intended for gen…

GE Healthcare, LLC

FDA Devices Moderate Jan 20, 2021

Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product Usage: inten…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Jan 20, 2021

Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Prod…

GE Healthcare, LLC

FDA Devices Moderate Jan 20, 2021

GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope trac…

GE Healthcare, LLC

FDA Devices Moderate Jan 20, 2021

GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope trac…

GE Healthcare, LLC

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarb…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by cli…

Medtronic Neuromodulation

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049

Remel Inc

FDA Devices Moderate Jan 20, 2021

Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707

Cook Medical Llc

FDA Devices Critical Jan 20, 2021

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVSUS270, GTIN 08714729960928, M…

Boston Scientific Corporation

FDA Devices Critical Jan 20, 2021

Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 08714729940838, Mad…

Boston Scientific Corporation

FDA Devices Moderate Jan 20, 2021

Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intend…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Jan 20, 2021

Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer …

GE Healthcare, LLC

FDA Devices Moderate Jan 20, 2021

The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. Th…

Roche Molecular Systems, Inc.

FDA Devices Moderate Jan 20, 2021

Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarb…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prolapse and for …

Baxter Healthcare Corporation

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jan 20, 2021

Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: inten…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

Fresenius Medical Care Holdings, 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: 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.