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 8 critical, 39 moderate, and 3 lower-severity recalls. The page references 24 distinct recalling firms operating in 10 distinct product categories, with 45 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (25), FDA Drug (12), CPSC (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 Jan 13, 2021

Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.

Boston Scientific Corporation

FDA Devices Moderate Jan 13, 2021

Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884510

Steris Corporation

FDA Devices Moderate Jan 13, 2021

TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.

Accuray Incorporated

FDA Devices Moderate Jan 13, 2021

CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001

Roche Diagnostics Operations, Inc.

FDA Devices Moderate Jan 13, 2021

Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.

Medline Industries Inc

FDA Devices Moderate Jan 13, 2021

CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975001 Units could consist of any of the following strip configurations: 6 count, 24 count, 2x 24 count (i.e. 48 strips)* *CoaguChek XS 3x48 promo LTC HH Catalog: 06298176001 CoaguChek XS 6x24 promo LTC HH Catalog:08468699001 CoaguChek XS 4x48 promo Catalog: 08468745001 CoaguChek XS 6x48 promo

Roche Diagnostics Operations, Inc.

FDA Devices Moderate Jan 13, 2021

Greffe Aorte-LF (product info is in French); Model DYNJ31877F - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.

Medline Industries Inc

FDA Devices Moderate Jan 13, 2021

Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.

Medline Industries Inc

FDA Devices Moderate Jan 13, 2021

Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884411

Steris Corporation

FDA Devices Moderate Jan 13, 2021

Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884515

Steris Corporation

FDA Devices Moderate Jan 13, 2021

Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884816

Steris Corporation

FDA Devices Moderate Jan 13, 2021

AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.

Boston Scientific Corporation

FDA Devices Moderate Jan 13, 2021

Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884713

Steris Corporation

FDA Devices Moderate Jan 13, 2021

Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.

Boston Scientific Corporation

FDA Devices Moderate Jan 13, 2021

Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883411

Steris Corporation

FDA Devices Moderate Jan 13, 2021

Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881031

Steris Corporation

FDA Devices Moderate Jan 13, 2021

AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.

Boston Scientific Corporation

FDA Devices Moderate Jan 13, 2021

TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.

Accuray Incorporated

FDA Devices Moderate Jan 13, 2021

Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fracture;

Smith & Nephew, Inc.

FDA Devices Moderate Jan 13, 2021

Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.

Medline Industries Inc

FDA Devices Moderate Jan 13, 2021

Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881041

Steris Corporation

CPSC No agency class Jan 13, 2021

Belkin Recalls Portable Wireless Chargers + Stand Special Edition Due to Fire and Shock Hazards

CPSC No agency class Jan 13, 2021

Juratoys Recalls Toy Trumpets Due to Choking Hazard

CPSC No agency class Jan 13, 2021

Sea to Summit Recalls Camping Pots Due to Burn and Scald Hazards

NHTSA No agency class Jan 13, 2021

RAM 2019-2020: SERVICE BRAKES, HYDRAULIC:POWER ASSIST:VACUUM:HOSES, LINES/PIPING, AND FITTINGS

RAM

NHTSA No agency class Jan 13, 2021

FREIGHTLINER 2020-2022: TIRES

FREIGHTLINER

NHTSA No agency class Jan 11, 2021

PETERBILT 2019-2020: STEERING:COLUMN

PETERBILT

CPSC No agency class Jan 7, 2021

John Deere Recalls Frontier Rotary Tillers Due to Injury Hazard (Recall Alert)

Deere & Company, of Moline, Ill.

CPSC No agency class Jan 7, 2021

Noble House Home Furnishings Recalls Chests, Cabinets and Dressers Due to Tip-Over and Entrapment Hazards (Recall Alert)

NHTSA No agency class Jan 7, 2021

VOLVO 2021: AIR BAGS

VOLVO

USDA FSIS Moderate Jan 7, 2021

FSIS Issues Public Health Alert for Not-Ready-to-Eat, Heat Treated, Not Fully Cooked Chicken Enchilada Products Due to Misbranding and an Undeclared Allergen

FDA Food Critical Jan 6, 2021

Trader Joe's Lightly Salted Edamame: Fully Cooked Soybeans in Pod. Keep Frozen NET WT 16 oz. (1 lb.) 454 g UPC: 0051 0639 Ingredients: Edamame (soybeans), salt Heating: microwave (1200 watt); Microwave cook times may vary depending on oven wattage. Open and pour into a microwave safe dish; heat 3-4 minutes at 50% power and serve. Distributed by Trader Joe's, Monrovia, CA Product of Thailand

TESOROS TRADING CO.

FDA Food Low Jan 6, 2021

Darlington's Soft Baked Cookies, Sugar Free Net Wt. 0.75 oz (21 g), Darlington, Noblesville, IN

HS Baking Enterprises LLC DBA Darlington Manufacturing

FDA Food Moderate Jan 6, 2021

Multigrain Solene Figotte, prebaked frozen breads with seeds, Item 29497, Net Weight 8.8 Lbs (4 Kg), Lot: 1234567, UPC code (01)03604380294973(10)1234567(15)191121(91)0309000001,

Landert LLC

FDA Drug Low Jan 6, 2021

Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospital/Office Use Only. US Compounding 1270 Don's Lane Conway, AR 72032 (800) 718-3588 NDC 62295-3324-05

US Compounding Inc

FDA Drug Moderate Jan 6, 2021

Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ - 07852 (844)446-6979

Imprimis NJOF, LLC

FDA Drug Moderate Jan 6, 2021

Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 NDC 69097-529-34

CIPLA

FDA Drug Moderate Jan 6, 2021

Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-528-34

CIPLA

FDA Drug Moderate Jan 6, 2021

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02

Fresenius Kabi USA, LLC

FDA Drug Critical Jan 6, 2021

Happy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO. 80301. UPC 6 56490 20223 5

Wishgarden Herbs, Incorporated

FDA Drug Moderate Jan 6, 2021

Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68

Ascend Laboratories LLC

FDA Drug Low Jan 6, 2021

NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816

Strides Pharma Inc.

FDA Drug Moderate Jan 6, 2021

Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88

Ascend Laboratories LLC

FDA Drug Critical Jan 6, 2021

Goldenseal POWDER, 0.25 oz. (7 g) plastic jars, WishGarden Herbs, Inc., Boulder, CO 80301. UPC 6 56490 64137 9

Wishgarden Herbs, Incorporated

FDA Drug Moderate Jan 6, 2021

Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-527-34

CIPLA

FDA Drug Critical Jan 6, 2021

Cord Care POWDER, 0.25 oz. (7 g) plastic jars, Wishgarden Herbs, Inc., Boulder, CO 80301. UPC 6-56490 24730 4

Wishgarden Herbs, Incorporated

FDA Devices Moderate Jan 6, 2021

Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL), scalpel, several syringes, table covers, stopcocks, inflation device, and gauze

Merit Medical Systems, Inc.

FDA Devices Moderate Jan 6, 2021

BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448417

Becton Dickinson & Co.

FDA Devices Moderate Jan 6, 2021

BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448608

Becton Dickinson & Co.

FDA Devices Moderate Jan 6, 2021

Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BASIC, Item 800109003 Lot # 83411. 3) Regard, MAJOR EAR, Item 800070009, Lot # 82442. 4) Regard, NEURO, Item 800040011, Lot # 82504. 5) Regard, LAP CHOLE, Item 800003011, Lot # 82497. 6) Regard, SHOULDER ARTHRO, Item 800075010, Lot # 82490. 7) Regard, CERVICAL, Item 800058007, Lot # 82592. 8) Regard, ARTHROSCOPY, Item 800027008, Lot # 82582. 9)

ROi CPS LLC

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 November 2026.