PlainRecalls

2018 Recall Year Insight

Federal agencies issued 7,928 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.59% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 21.7 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 159 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 2018.

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 8 distinct product categories, with 46 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (18), FDA Food (13), FDA Drug (11), 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 2018 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 Feb 28, 2018

LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments

Synthes, Inc.

FDA Devices Low Feb 28, 2018

Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503

Ivoclar Vivadent, Inc.

FDA Devices Moderate Feb 28, 2018

Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is collected, de foamed and filtered before mixing with the venous blood. The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with filter is intended to be used in an extra

Medtronic Perfusion Systems

FDA Devices Moderate Feb 28, 2018

Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product code: ASK-45703-PHF2; Exp. Dates Feb 2018 - Nov 2018

Arrow International Inc

FDA Devices Moderate Feb 28, 2018

Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installed. The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow

Philips Electronics North America Corporation

FDA Devices Critical Feb 28, 2018

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: a. Compia MRI CRT-D DF1 (Product No. DTMC1D1); b. Compia MRI Quad CRT-D DF4 (Product No.DTMC1QQ ) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate Feb 28, 2018

Medtronic Inc.

FDA Devices Moderate Feb 28, 2018

Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy

DeRoyal Industries Inc

FDA Devices Moderate Feb 28, 2018

Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 28, 2018

AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 2018 - Nov 2018

Arrow International Inc

FDA Devices Moderate Feb 28, 2018

Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)

Philips Consumer Lifestyle

FDA Devices Critical Feb 28, 2018

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1); c. Amplia MRI Quad CRT-D DF4 (Product No. DTMB1QQ); EXPANSION: d. Amplia MRI CRT-D DF1 (Product No. DTMB1D1) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some d

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Critical Feb 28, 2018

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria MRI CRT-D DF1 (Product No. DTMA1D1); b. Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ); EXPANSION: c. Claria MRI CRT-D DF4 (Product No. DTMA1D4); d. Claria MRI Quad CRT-D DF1 (Product No. DTMA1Q1) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate Feb 28, 2018

Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit; Product Codes: ASK-45703-PNHS; ASK-45703-PGMCL; ASK-45703-PNW; Exp. Dates Feb 2018 - Nov 2018

Arrow International Inc

FDA Devices Moderate Feb 28, 2018

Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) with reference vessel diameters from 4.0 mm to 7.0 mm and lesion lengths up to 190 mm. a. H74939180051870 (Material Description Innova-E

Boston Scientific Corporation

FDA Devices Moderate Feb 28, 2018

20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

FDA Devices Moderate Feb 28, 2018

Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.

Fujifilm Medical Systems U.S.A., Inc.

FDA Devices Moderate Feb 28, 2018

Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Covidien LLC

CPSC No agency class Feb 28, 2018

PL Sleep Children's Sleepwear Recalled by Lemur Group Due to Violation of Federal Flammability Standard

NHTSA No agency class Feb 27, 2018

HYUNDAI 2011-2013: SEAT BELTS:PRETENSIONER

HYUNDAI

CPSC No agency class Feb 26, 2018

Allen Sports Recalls Folding Bicycles Due to Fall Hazard

CPSC No agency class Feb 22, 2018

Monster Moto Recalls Mini Bikes Due to Fire Hazard

Monster Moto LLC, of Ruston, La.

CPSC No agency class Feb 22, 2018

Yamaha Recalls Golf Cars and Personal Transportation Vehicles Due to Crash Hazard (Recall Alert)

Yamaha Motor Manufacturing Corporation of America, of Newnan, Ga.

NHTSA No agency class Feb 22, 2018

JEEP 2017: ENGINE AND ENGINE COOLING:ENGINE

JEEP

NHTSA No agency class Feb 22, 2018

TOYOTA 2018: WHEELS

TOYOTA

NHTSA No agency class Feb 22, 2018

RAM 2018: EQUIPMENT:OTHER:LABELS

RAM

FDA Food Moderate Feb 21, 2018

General Mills, Inc

FDA Food Moderate Feb 21, 2018

BROLITE PRODUCT #6109 BREAD FLAVOR R, Net Wt. 50 Lbs

Brolite Products Inc

FDA Food Moderate Feb 21, 2018

BROLITE PRODUCT #5015 SPONGE AND DOUGH, Net Wt. 50 Lbs

Brolite Products Inc

FDA Food Critical Feb 21, 2018

Arthri-D 120ct

ABH Nature's Products, Inc.

FDA Food Moderate Feb 21, 2018

WALNUT CREEK FOODS Caramel Popcorn NET WT 15 OZ (425g) Ingredients: Evaporated Can Juice, Popcorn, Butter (cream, salt), Salt, Sodium Bicarbonate, Cream of Tartar Contains: Milk Distributed by: Walnut Creek Foods, Walnut Creek, OH 44687 UPC 25555 99857 2

Coblentz Distributing Inc dba Walnut Creek Foods

FDA Food Moderate Feb 21, 2018

STAR WARS TIN WITH CARAMEL POPCORN NET WT 3.5 oz (99g) CONTAINS MILK AND SOY, MAY CONTAIN TREE NUTS AND PEANUTS DISTRIBUTED BY GALERIE HEBRON, KENTUCKY 41048 UPC 7 68395 51585 0

Ross Acquisitions Company

FDA Food Critical Feb 21, 2018

Weis Weis Markets, Inc., Sunbury, PA 17801-0471; Keep Refrigerated; Dried Beef Party Rye Dip; Ingredients: Hellman's Mayonaise, Sour Cream, Dried Beef (Cured with Water, Salt, Sugar, Sodium Nitrate, Sodium Nitrite), Parsley, Onion, Dill Weed; SELL BY RANGE up to 02/16/2018.

WEIS MARKETS

FDA Food Moderate Feb 21, 2018

#6600 TJ TORTILLA, Net Wt. 50 Lbs

Brolite Products Inc

FDA Food Moderate Feb 21, 2018

Live Better Drug Free Black Elderberry Syrup, 4 FL OZ (118 mL); DIETARY SUPPLEMENT, UPC 050428581186

Kingston Pharma LLC

FDA Food Moderate Feb 21, 2018

Hibiscus Lavender Syrup, packaged in 100 mL or 250 mL glass bottle. 100 mL bottle has UPC 8 53142 00505 7. 250 mL bottle has UPC 8 53142 00507 1. These bottles are also sold in the following cocktail kits: -Portland Pony -Dark and Stormy -Whiskey Ginger Smash -Sun Hat -Hibiscus Margarita The label is read in parts: "***RAFT BOTANICALS HIBISCUS LAVENDER COCKTAIL + SODA SYRUP***Slow-brewed in Portland, Oregon***100 ml (3.4 FL OZ)***Ingredients: Organic Cane Sugar, Water, Organic Hi

Improper Goods

FDA Food Moderate Feb 21, 2018

Lemon Ginger Syrup, packaged in 100 mL or 250 mL glass bottle. 100 mL bottle has UPC 8 53142 00504 0. 250 mL bottle has no UPC code. These bottles are also sold in the following cocktail kits: -Portland Pony -Dark and Stormy -Whiskey Ginger Smash -Sun Hat -Hibiscus Margarita The label is read in parts: "***RAFT LEMON GINGER***BOTANICAL COCKTAIL + SODA SYRUP***Slow-brewed in Portland, Oregon***Ingredients: Organic Cane Sugar, Water, Organic Ginger, Organic Orange Peel***Improper Go

Improper Goods

FDA Food Critical Feb 21, 2018

Zero for Him 150 count

ABH Nature's Products, Inc.

FDA Food Moderate Feb 21, 2018

Frozen Sliced (blanched) Squash packed in 1400 lb. plastic totes.

Hanover Foods Corporation

FDA Drug Moderate Feb 21, 2018

Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains 2 Suction Toothbrushes with sodium bicarbonate, 0.25 fl oz/7ml Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6570

Sage Products Inc

FDA Drug Moderate Feb 21, 2018

Q Care RX Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 1 Untreated Suction Toothbrush packages, 1 Single dose bottle of 0.12% CHG Oral Rinse, 2 Suction Oral Swab packages with Perox-A-Mint, 1 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 9002 UPC 6 18029 83025 8

Sage Products Inc

FDA Drug Moderate Feb 21, 2018

Toothette Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. Includes 0.25 fl.oz./7mL Perox-A-Mint solution, 0.07oz/2g Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. NDC: 53462-922-16

Sage Products Inc

FDA Drug Low Feb 21, 2018

Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by Genentech USA, Inc. A Member of the Roach Group, 1 DNA Way South San Francisco, CA 94080-4990. NDC 0004-0068-01

Genentech, Inc.

FDA Drug Low Feb 21, 2018

Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun Pharmaceutical Ind. Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol - 389 350, Gujarat, India --- NDC 47335-779-91

Sun Pharmaceutical Industries, Inc.

FDA Drug Moderate Feb 21, 2018

Toothette Oral Care Short-Term Oral Swab System with Perox-A-Mint solution, Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44ml bottle Perox-A-Mint solution, .5 oz/14g tube of Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product code 6000, UPC 6 18029 8001 5

Sage Products Inc

FDA Drug Moderate Feb 21, 2018

Toothette Oral Care Suction Toothbrushes with Antiseptic Oral Rinse and Mouth Moisturizer, Contains 2 Suction Toothbrushes with sodium bicarbonate. 0.25 fl oz/7ml Antiseptic Oral Rinse, 0.07 oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6173

Sage Products Inc

FDA Drug Moderate Feb 21, 2018

Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yankauer, 3 Suction Toothbrush packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6308 UPC 6 18029 83040 1

Sage Products Inc

FDA Drug Moderate Feb 21, 2018

Oral Cleansing & Suctioning System q2 with 0.12% Chlorexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, packages SYS W/CHG 10, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6592

Sage Products Inc

FDA Drug Moderate Feb 21, 2018

Q Care Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 4 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6994 UPC 6 18029 83094 4

Sage Products Inc

FDA Drug Moderate Feb 21, 2018

0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC

PharMEDium Services, LLC

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2018 with 2017 →

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 2018

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 2018 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.