PlainRecalls

2018 Recalls

7,717 recalls · Page 78 of 155

2018 Recall Year Insight

Federal agencies issued 7,717 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 9.19% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 21.1 recalls per day across the FDA, CPSC, 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 155 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 0 critical, 49 moderate, and 1 lower-severity recalls. The page references 17 distinct recalling firms operating in 1 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (50), 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, 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

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116PC

Sun Med, LLC

FDA Devices Moderate Jun 20, 2018

Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 172…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Jun 20, 2018

RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity…

BioMerieux SA

FDA Devices Moderate Jun 20, 2018

RS 5F DL BIOFLO PASV, Catalog Number 60M150373

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 3…

Zimmer Biomet, Inc.

FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1116F

Sun Med, LLC

FDA Devices Moderate Jun 20, 2018

Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the h…

Shimadzu Medical Systems

FDA Devices Moderate Jun 20, 2018

Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardio…

Maquet Cardiopulmonary Ag

FDA Devices Moderate Jun 20, 2018

CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: Th…

Cellavision AB

FDA Devices Moderate Jun 20, 2018

Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary Bypass…

Datascope Corporation

FDA Devices Moderate Jun 20, 2018

Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulm…

Maquet Cardiopulmonary Ag

FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1126

Sun Med, LLC

FDA Devices Moderate Jun 20, 2018

Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes. Laser scanning…

Zeiss, Carl Inc

FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK 5, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116PD5

Sun Med, LLC

FDA Devices Moderate Jun 20, 2018

RS 5F DL BIOFLO PASV, Catalog Number 60M181578

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

RS 5F DL BIOFLO PICC, Catalog Number 60M071831

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

DermaPro Waterproof Silicone Tape, SNS57232

Safe N Simple, LLC

FDA Devices Moderate Jun 20, 2018

smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)

Smith & Nephew, Inc.

FDA Devices Moderate Jun 20, 2018

Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek Performa test strips are for…

Roche Diabetes Care, Inc.

FDA Devices Moderate Jun 20, 2018

The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most significant …

BioMerieux SA

FDA Devices Moderate Jun 20, 2018

Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124

Angiodynamics Inc. (Navilyst Medical Inc.)

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: T…

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 f…

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 ED…

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 clin…

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 ot…

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 …

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 …

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, accord…

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 met…

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

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: CPSC + NHTSA — consumer product and vehicle recall feeds for 2018