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 5 critical, 44 moderate, and 1 lower-severity recalls. The page references 18 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 (42), NHTSA (5), CPSC (2), 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 Jun 20, 2018

Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

RS 5F DL XPP KIT, Catalog Number 60M183104

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

Roche Diabetes Care, Inc.

FDA Devices Moderate Jun 20, 2018

Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product Usage: The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heel stick, or fresh capillary whole blood samples drawn from the fingertips as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus,

Roche Diabetes Care, Inc.

FDA Devices Moderate Jun 20, 2018

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Ion Beam Applications S.A.

FDA Devices Low Jun 20, 2018

lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cutoff of 100 ng/ml. This test provides only a preliminary analytical test result and a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry or Liquid Chromatography/Tandem Mass Spectrometry, must be used to obtain a confirmed analytical result.

Alere San Diego Inc. DBA Immunalysis Corporation

FDA Devices Moderate Jun 20, 2018

The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for the automated identification of most clinically significant fastidious organisms. The VITEK 2 NH identification card is a single-use disposable. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated

BioMerieux SA

FDA Devices Moderate Jun 20, 2018

Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

Proteus 235 The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

Ion Beam Applications S.A.

FDA Devices Moderate Jun 20, 2018

The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic gram negative bacilli to antimicrobial agents. Fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolat

BioMerieux SA

FDA Devices Moderate Jun 20, 2018

Oxidase Reagent (ref: 55635): This test is used to detect the production of the enzyme cytochrome oxidase by bacteria. This enzyme is characteristic of the genus Neisseria and most species of Pseudomonas. It enables the differentiation of Gram (-) bacilli (1, 2). A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips i

BioMerieux SA

FDA Devices Moderate Jun 20, 2018

CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray system

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 20, 2018

RS 5F DL BIOFLO PASV, Catalog Number 60M183481

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116FC

Sun Med, LLC

FDA Devices Moderate Jun 20, 2018

The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method. The PREVI¿ Color Gram instrument sprays the PREVI¿ Color Gram reagents onto microscope slides which have been smeared with specimens to be examined. The staining procedure is rapid and precise. Each reagent has a specific position (A, B, C, D, E) on the PREVI¿ Color Gram platform that is also indicated on the reagent label.

BioMerieux SA

FDA Devices Moderate Jun 20, 2018

RS 5F DL XCELA PICC, Catalog Number 60M122272

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146

Philips Electronics North America Corporation

FDA Devices Moderate Jun 20, 2018

Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to the Gram method. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

BioMerieux SA

FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126C

Sun Med, LLC

FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126FPC

Sun Med, LLC

FDA Devices Moderate Jun 20, 2018

BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-019

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-038

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.

Zimmer Biomet, Inc.

FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126P

Sun Med, LLC

FDA Devices Moderate Jun 20, 2018

IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351

Philips Electronics North America Corporation

FDA Devices Moderate Jun 20, 2018

RS 5F DL XPP, Catalog Number 60M030393

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian

The Seaberg Company Inc

FDA Devices Moderate Jun 20, 2018

Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalog Number 45-895

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-033

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

RS TANDEM 5F DL BIOFLO PICC, Catalog Number 60M250097

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002267, Article Number A24-7107. For use in cardiopulmonary bypass

Maquet Cardiopulmonary Ag

FDA Devices Moderate Jun 20, 2018

RS 5F DL BIOFLO PASV, Catalog Number 60M161567

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1

Sun Med, LLC

FDA Devices Moderate Jun 20, 2018

Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901

Angiodynamics Inc. (Navilyst Medical Inc.)

CPSC No agency class Jun 20, 2018

Werner Recalls Aluminum Ladders Due to Fall Hazard

NHTSA No agency class Jun 20, 2018

HONDA 2018: EQUIPMENT:OTHER:LABELS

HONDA

USDA FSIS Critical Jun 20, 2018

Texas Natural Meats Recalls Frozen Raw Ground Beef Products

Texas Natural Meats

CPSC No agency class Jun 19, 2018

Women's Scarves Recalled by Yangtze Store Due to Violation of Federal Flammability Standard Hazard; Sold Exclusively on Amazon.com (Recall Alert)

Jin Bo Si Chou Fu Shi You Xian Gong Si, of China

NHTSA No agency class Jun 18, 2018

INTERNATIONAL 2018-2019: FUEL SYSTEM, DIESEL

INTERNATIONAL

NHTSA No agency class Jun 15, 2018

FREIGHTLINER 2018-2019: SERVICE BRAKES, AIR:DISC:CALIPER

FREIGHTLINER

NHTSA No agency class Jun 15, 2018

BMW 2018: STRUCTURE:MOTORCYCLE:KICKSTAND/CENTER STAND

BMW

NHTSA No agency class Jun 15, 2018

MERCEDES-BENZ 2018: ELECTRICAL SYSTEM

MERCEDES-BENZ

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.