2021 Recalls
5,231 federal recalls indexed for 2021 · Page 48 of 105
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 5 critical, 44 moderate, and 1 lower-severity recalls. The page references 25 distinct recalling firms operating in 6 distinct product categories, with 46 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (32), CPSC (7), FDA Food (6), 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.
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient acro
Fresenius Medical Care Holdings, Inc.
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
Encore Medical, LP
SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting.
Soft Computer Consultants, Inc.
Medtronic Reveal LINQ LNQ11 / PA96000
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws
Cardinal Health 200, LLC
Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513
Cell Marque Corporation
3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data monitor.
Mindray DS USA, Inc. dba Mindray North America
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral, 36mm. Orthopedic hip implant component.
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm Lateralized, 28mm; and Novation GXL Liner, +5mm Lateralized, G0, 22mm ID. Orthopedic hip implant component.
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.
Exactech, Inc.
The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler, Newton IQO cycler).
Fresenius Medical Care Holdings, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and Novation GXL Liner, Lipped Ant, 28mm. Orthopedic hip implant component.
Exactech, Inc.
Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)
Caption Health
026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting
Fresenius Medical Care Holdings, Inc.
Stimulen Collagen Moisturizing Lotion, ST9555B
Southwest Technologies Inc
Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.
Respironics California, LLC
Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979
Stryker Spine
Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws
Cardinal Health 200, LLC
NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. NaturaLyte Dry Bicarbonate Concentrate is formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osm
Fresenius Medical Care Holdings, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-22-XX, Novation GXL Liner, +5mm Lateralized, G00, 22mm ID. Orthopedic hip implant component.
Exactech, Inc.
The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler se
Fresenius Medical Care Holdings, Inc.
AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.
Mediana Co., Ltd.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, Acumatch GXL 15 Degree Liner, 36mm, and Novation GXL Liner, Lipped Ant, 36mm; and Novation GXL Liner, Lipped, 36mm. Orthopedic hip implant component.
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-28-XX, Acumatch GXL 0 Degree Liner, 28mm; Novation GXL Liner, Neutral, 28mm; and Novation GXL Neutral Liner, G0, 28mm ID. Orthopedic hip implant component.
Exactech, Inc.
Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798
Cell Marque Corporation
Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
Gentherm Medical, LLC
050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe¿ Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows: Indications for Use Fresenius Sterile Stay Safe¿ Cap is intended to be used for closure of the stay safe peritoneal dialysis connectology system
Fresenius Medical Care Holdings, Inc.
SoftCytogenetics
Soft Computer Consultants, Inc.
ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administration of the Moderna COVID-19 vaccine convenience kit for the administration of the COVID-19 vaccine
Mckesson Medical-Surgical Inc. Corporate Office
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-36-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant, 32mm; and Novation GXL Liner, Lipped, 32mm. Orthopedic hip implant component.
Exactech, Inc.
Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC
Dutch Ophthalmic USA, Inc.
Birkenstock USA Recalls Kids' Mogami Sandals Due to Choking Hazard
Children's Pajamas Recalled Due to Violation of Federal Flammability Standard and Burn Hazard; Manufactured by Tkala Fashion; Sold Exclusively on Amazon.com
Tkala Fashion, of Shenzen, China
KIA 2022: ELECTRICAL SYSTEM: INSTRUMENT CLUSTER/PANEL
KIA
Facebook Technologies Recalls Removable Foam Facial Interfaces for Oculus Quest 2 Virtual Reality Headsets Due to Skin Irritation Hazard (Recall Alert)
AUDI 2020-2021: SERVICE BRAKES, HYDRAULIC
AUDI
Top Notch Jerky LLC. Recalls Beef Jerky Products Due to Misbranding and Undeclared Allergens
MCLAREN 2019: SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS:HOSES, LINES/PIPING, AND FITTINGS
MCLAREN
CHEVROLET 2017-2019: ELECTRICAL SYSTEM:PROPULSION SYSTEM:TRACTION BATTERY
CHEVROLET
Bel Furniture Recalls Barrington 5-Drawer Chests Due to Tip-Over and Entrapment Hazards; Sold Exclusively at Bel Furniture (Recall Alert)
BRP Recalls Side-by-Side Vehicles Due to Fire Hazard (Recall Alert)
BRP U.S. Inc., of Sturtevant, Wis.
Polaris Recalls GENERAL Recreational Off-Highway Vehicles Due to Crash Hazard (Recall Alert)
Polaris Inc., of Medina, Minn.
Polaris Recalls RZR Recreational Off-Road Vehicles Due to Fire Hazard (Recall Alert)
Living Free Nerve & Muscle Plus Cetyl-Myristoleate Herbal and Glandular Supplement, 180 and 500 capsules per bottles. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "***Living Free Nerve & Muscle Plus Cetyl-Myristoleate *** Herbal and Glandular Supplement***Formulated by Beatrice Lydecker ***Manufactured by Bea Lydecker's Naturals Oregon City, OR***".
Bea Lydeckers Naturals Inc
Living Free Immune Dietary Supplement, 100 and 500 capsules per bottles. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "***Living Free Immune Dietary Supplement***Glandular and Herbal Supplement***Formulated by Beatrice Lydecker ***Manufactured by Bea Lydecker's Naturals Oregon City, OR*** 503-631-8589***".
Bea Lydeckers Naturals Inc
Living Free Nerve & Muscle Herbal Dietary Supplement, 100 and 500 capsules per bottles. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "***Living Free Nerve & Muscle Herbal Dietary Supplement***Herbal and Glandular Supplement***Formulated by Beatrice Lydecker ***Manufactured by Bea Lydecker's Naturals Oregon City, OR*** 503-631-8589***".
Bea Lydeckers Naturals Inc
Living Free "Adult Extra" multi-vitamin, 100 or 500 capsules per bottle. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "**Living Free Adult Extra***Natural Vitamin Mineral Herbal Glandular Supplements***Formulated and Manufactured by BEA LYDECKER's NATURALS Oregon City, OR*** 503-631-8589***".
Bea Lydeckers Naturals Inc
Living Free Lung & Joint Congestion Herbal Dietary Supplement, 100 and 500 capsules per bottles. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "***Living Free Lung & Joint Congestion Herbal Dietary Supplement***Glandular, Herbal & Vitamin Supplement***Formulated by Beatrice Lydecker ***Manufactured by Bea Lydecker's Naturals Oregon City, OR*** 503-631-8589***".
Bea Lydeckers Naturals Inc
Caribbean Belize Spices Caribbean Rub, Net Wt. 3.5oz (99g) Plastic bottle with black cap Sold as single bottles
Caribbean Belize LLC
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: 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.