PlainRecalls

2018 Recalls

6,355 recalls · Page 65 of 128

2018 Recall Year Insight

Federal agencies issued 6,355 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.57% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 17.4 recalls per day across the FDA, CPSC, NHTSA, and USDA FSIS 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 128 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 9 critical, 41 moderate, and 0 lower-severity recalls. The page references 25 distinct recalling firms operating in 3 distinct product categories, with 40 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (38), NHTSA (10), 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, NHTSA, or USDA FSIS 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

Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Jun 20, 2018

remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative pr…

Thermo Fisher

FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116P

Sun Med, LLC

FDA Devices Moderate Jun 20, 2018

IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350

Philips Electronics North America Corporation

FDA Devices Moderate Jun 20, 2018

Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126F

Sun Med, LLC

FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1116

Sun Med, LLC

FDA Devices Moderate Jun 20, 2018

CAN 5F DUAL XCELA PICC, Catalog Number 60M701532

Angiodynamics Inc. (Navilyst Medical Inc.)

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.

CPSC Moderate Jun 20, 2018

Werner Recalls Aluminum Ladders Due to Fall Hazard

NHTSA Critical Jun 20, 2018

HONDA 2018: EQUIPMENT:OTHER:LABELS

HONDA

CPSC Moderate 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 Critical Jun 18, 2018

INTERNATIONAL 2018-2019: FUEL SYSTEM, DIESEL

INTERNATIONAL

NHTSA Critical Jun 15, 2018

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

FREIGHTLINER

NHTSA Moderate Jun 15, 2018

BMW 2018: STRUCTURE:MOTORCYCLE:KICKSTAND/CENTER STAND

BMW

NHTSA Critical Jun 15, 2018

MERCEDES-BENZ 2018: ELECTRICAL SYSTEM

MERCEDES-BENZ

NHTSA Critical Jun 15, 2018

MAZDA 2005-2009: AIR BAGS:FRONTAL:PASSENGER SIDE:INFLATOR MODULE

MAZDA

NHTSA Critical Jun 15, 2018

MAZDA 2009-2010: AIR BAGS:FRONTAL:PASSENGER SIDE:INFLATOR MODULE

MAZDA

NHTSA Critical Jun 15, 2018

MAZDA 2003-2011: AIR BAGS:FRONTAL:PASSENGER SIDE:INFLATOR MODULE

MAZDA

NHTSA Critical Jun 15, 2018

NISSAN 2010-2012: AIR BAGS:FRONTAL:PASSENGER SIDE:INFLATOR MODULE

NISSAN

NHTSA Critical Jun 14, 2018

CHEVROLET 2016-2018: AIR BAGS:SENSOR:OCCUPANT CLASSIFICATION

CHEVROLET

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 + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2018