2021 Recalls
5,086 recalls · Page 98 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 10 critical, 37 moderate, and 3 lower-severity recalls. The page references 33 distinct recalling firms operating in 5 distinct product categories, with 48 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (26), FDA Food (11), FDA Drug (10), 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.
Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132 The Penumbra JET 7 Reper…
Penumbra Inc.
ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.
Beckman Coulter Inc.
OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The product provides a bone void filler…
Skeletal Kinetics, Llc
ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead i…
Boston Scientific Corporation
Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT The Penumbra JET 7 Reperfusion Catheter with Xtra …
Penumbra Inc.
Synapse PACS Software Versions 5.1 and higher
Fujifilm Medical Systems U.S.A., Inc.
CB2 Recalls Junction Tall Chests and Low Dressers Due to Tip-Over and Entrapment Hazards
AUDI 2019: STEERING:CRITICAL FASTENERS
AUDI
INFINITI 2020: TIRES
INFINITI
Frozen Ground Tuna, Wild Caught, Production Date: 06/01/2020. Product of Vietnam, Net Wt: 11 lbs. x 2: 22 lbs. Imported by Khee Trading, Inc., Comp…
Ocean Providence Minneapolis LLC
SAMYANG Buldak Hot Chicken Flavor Sauce, Hot Chili Sauce, Net Wt.: 200g (7.05oz)
BLUE STONE IMPORT USA INC
Material Number: 7002 3/8 Diced Green Chile INGREDIENTS: Green Chilies, Citric Acid PRODUCT OF: MEXICO UNIT OF MEASURE: 440 +/- 5 LBS packaged in 50…
SUN VALLEY FOODS LLC
"Divvies Vegan and Nut Free Vanilla Cupcakes with Vanilla Frosting ***Net. Wt. 6 oz. "
Divvies LLC
NETUNO Caribbean Red Snapper, Net Weight 10 Lbs (4.54 Kg), Item 101229, Product Must be Fully Cooked Prior to Consumption, 1.5-2.0 LB
Netuno USA, Inc.
SAMYANG Buldak Hot Chicken Flavor Sauce - Carbonara, Hot Chili Sauce, Net Wt.: 200g (7.05oz)
BLUE STONE IMPORT USA INC
Herring in Oil with Italian Spices: Ingredients: Herring fillet pieces (fish) sunflower oil refined deodorized, edible salt, ground spices (chili, m…
B & I Overseas Trading Inc.
"Divvies Vegan and Nut Free Vanilla Cupcakes with Chocolate Frosting ***Net. Wt. 6 oz.***"
Divvies LLC
Food Club Garlic Powder, 5.37 ounce bottles, 12 bottles per case. " Best 324A0 C By NOV 19 22 / Best 325A0 By NOV 20 22
B&G Foods North America, Inc
SAMYANG Buldak Hot Chicken Flavor Sauce - Extremely Spicy, Hot Chili Sauce, Net Wt.: 200g (7.05oz)
BLUE STONE IMPORT USA INC
First Street Goody Goody Trail Mix 10 oz. (283g)S&F Item#52892 Unit UPC# 797565204201; First Street Goody Goody Trail Mix 16 oz. (454g) S&F Item#52…
Western Mixers Produce & Nuts, Inc.
Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) N…
Sunstar Americas, Inc.
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.
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.
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
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
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.
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
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
Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas C…
Nostrum Laboratories Inc
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.
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.
SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
Siemens Medical Solutions USA, Inc
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714729960904
Boston Scientific Corporation
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.
Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
Siemens Medical Solutions USA, Inc
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
Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during transportat…
Steris Corporation
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.
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 08714729960911, M…
Boston Scientific Corporation
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.
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.
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
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
CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software U…
Medtronic Inc.
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
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
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.
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
Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product Usage: inten…
Siemens Healthcare Diagnostics, Inc.
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.
Nearby Recall Years
Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.
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
Read our methodology — how this data is sourced, computed, and verified.