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 9 critical, 41 moderate, and 0 lower-severity recalls. The page references 28 distinct recalling firms operating in 4 distinct product categories, with 45 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (35), FDA Food (9), NHTSA (5), 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 Devices Moderate Sep 8, 2021

EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129

Thera Test Laboratories, Inc.

FDA Devices Moderate Sep 8, 2021

Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144

Covidien, LP

FDA Devices Moderate Sep 8, 2021

Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019

Covidien, LP

FDA Devices Moderate Sep 8, 2021

Merge Hemo, Software packages 10.2, 10.3, and 10.4

Merge Healthcare, Inc.

FDA Devices Moderate Sep 8, 2021

Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133

Covidien, LP

FDA Devices Moderate Sep 8, 2021

Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023

Covidien, LP

FDA Devices Moderate Sep 8, 2021

Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002

Clarus Medical, Llc

FDA Devices Moderate Sep 8, 2021

TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420907

DePuy Orthopaedics, Inc.

FDA Devices Moderate Sep 8, 2021

Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P

Covidien, LP

FDA Devices Moderate Sep 8, 2021

Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123

Covidien, LP

FDA Devices Moderate Sep 8, 2021

Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055

Covidien, LP

FDA Devices Moderate Sep 8, 2021

CombiDiagnost R90 Software Version R1.0 and R1.1

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Sep 8, 2021

Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.

Baxter Healthcare Corporation

FDA Devices Moderate Sep 8, 2021

Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms. Emergency

Versea Diagnostics LLC

FDA Devices Moderate Sep 8, 2021

TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420581

DePuy Orthopaedics, Inc.

FDA Devices Moderate Sep 8, 2021

Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119

Covidien, LP

FDA Devices Moderate Sep 8, 2021

smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.

Smiths Medical ASD Inc.

FDA Devices Moderate Sep 8, 2021

Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028

Covidien, LP

FDA Devices Moderate Sep 8, 2021

DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145

Cardiovascular Systems Inc

FDA Devices Moderate Sep 8, 2021

Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories. Authorized Laboratories: Laboratories certi

Versea Diagnostics LLC

FDA Devices Moderate Sep 8, 2021

Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44cm, Item Code 8888541044

Covidien, LP

FDA Devices Moderate Sep 8, 2021

Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300

Aspen Surgical Products, Inc.

FDA Devices Moderate Sep 8, 2021

Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from Catheter Port to BD Vacutainer¿ Blood Collection or Urine Collection Tubes.

Magnolia Medical Technologies, Inc.

FDA Devices Moderate Sep 8, 2021

CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2

Zeltiq Aesthetics, Inc

FDA Devices Moderate Sep 8, 2021

Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P

Covidien, LP

FDA Devices Moderate Sep 8, 2021

TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420917

DePuy Orthopaedics, Inc.

FDA Devices Moderate Sep 8, 2021

Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128

Covidien, LP

FDA Devices Moderate Sep 8, 2021

Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC

Olympus Corporation of the Americas

FDA Devices Moderate Sep 8, 2021

TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420916

DePuy Orthopaedics, Inc.

FDA Devices Moderate Sep 8, 2021

Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100

Aspen Surgical Products, Inc.

FDA Devices Moderate Sep 8, 2021

TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420578

DePuy Orthopaedics, Inc.

FDA Devices Moderate Sep 8, 2021

CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no mo

Versea Diagnostics LLC

FDA Devices Moderate Sep 8, 2021

STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO

Cardiovascular Systems Inc

FDA Devices Moderate Sep 8, 2021

MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001

MY01, INC.

FDA Devices Moderate Sep 8, 2021

Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10

Elekta Inc

NHTSA No agency class Sep 8, 2021

PORSCHE 2020-2021: SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS

PORSCHE

NHTSA No agency class Sep 8, 2021

VOLKSWAGEN 2021: SERVICE BRAKES, HYDRAULIC:CRITICAL FASTENERS

VOLKSWAGEN

CPSC No agency class Sep 2, 2021

Step2® Recalls StepUp Sidekick Learning Towers™ Due to Fall Hazard (Recall Alert)

The Step2 Company LLC, of Streetsboro, Ohio

NHTSA No agency class Sep 2, 2021

HONDA 2019: SERVICE BRAKES, HYDRAULIC

HONDA

NHTSA No agency class Sep 2, 2021

FREIGHTLINER

NHTSA No agency class Sep 2, 2021

TOYOTA 2018-2021: EXTERIOR LIGHTING:HEADLIGHTS

TOYOTA

FDA Food Moderate Sep 1, 2021

Gordon Choice Deli Style Tuna Salad, Refrigerated, 4 Lb. retail unit, 2 4 Lb. retail units per wholesale case. Wholesale case labeled as Deli Style Tuna Salad The recalled product contains tuna salad, but it has two labels. The bottom container states Deli Style Chicken Salad, while the top lid label states Deli Style Tuna Salad. The Gordon Choice Deli Style Tuna Salad, UPC found on the lid is 0 9390113900 9. The Gordon Choice Deli Style Chicken Salad, UPC found on the bottom tub is 0

RMH Foods

FDA Food Moderate Sep 1, 2021

Crunchmaster Multi Grain Baked Gluten-Free Crackers 5-Seed Sesame, Amaranth, Flax, Chia & Quinoa 20 oz. UPC Code: 8-79890-00220-9

TH Foods Inc

FDA Food Moderate Sep 1, 2021

Wegmans Sunflower Crunch Chopped Salad Kit: Includes Green Cabbage, Green Leaf Lettuce, Sunflower Seeds, Red Cabbage, Carrot, Kale, Uncured Bacon, Green Onion with Wegmans Organic Coleslaw dressing. Washed and ready to eat. Salad and toppings: Net Wt 10.1 oz. (286 g) Dressing: Net 2.58 Fl Oz. (76 mL) Total Net Wt 12.6 oz. (357 g) UPC: 0 77890 50238 9. Distributed by Wegmans Markets Inc., Rochester, NY 14603 Allergens: Contains Eggs

Taylor Farms Retail, Inc.

FDA Food Critical Sep 1, 2021

1. Cahills Ireland Original Irish Porter 5lbs.Waxed Deli Wheel 2. Cahills Ireland Original Irish Porter 2.4 lbs.

CAHILLS FARM CHEESE LIMITED

FDA Food Moderate Sep 1, 2021

Assist and Amend Advanced Digestive Enzyme Formula, Dietary Supplement, 60 capsules per bottle, Manufactured for and distributed by New Dawn Nutrition Omaha, NE

New Dawn Nutrition, Inc.

FDA Food Critical Sep 1, 2021

Cahills Ireland Whiskey Cheese - 5lb. Waxed Deli Wheel

CAHILLS FARM CHEESE LIMITED

FDA Food Critical Sep 1, 2021

Cahills Ireland Red Wine - 5 lbs. Waxed Deli Wheel

CAHILLS FARM CHEESE LIMITED

FDA Food Moderate Sep 1, 2021

Hiland 100% Pure Apple Juice From Concentrate No Sugar Added Pasteurized 4 FL OZ (118 mL) packaged in paper cartons 75 cartons per case

Hiland Dairy Foods Company LLC

FDA Food Critical Sep 1, 2021

Lidl Preferred Selection-Red Wine Cheddar - 7 oz.

CAHILLS FARM CHEESE LIMITED

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.