PlainRecalls

2018 Recalls

6,355 recalls · Page 20 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 6 critical, 41 moderate, and 3 lower-severity recalls. The page references 22 distinct recalling firms operating in 6 distinct product categories, with 44 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (38), NHTSA (6), CPSC (4), 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 Nov 7, 2018

Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-80-12.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pal…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

Zilver 518 Biliary Stent 4mm x 40mm, Catalog Number: ZIB5-125-4.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pall…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-125-5.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pall…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

Zilver 518 Biliary Stent 4mm x 20mm, Catalog Number: ZIB5-125-4.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pallia…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pall…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-80-14.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pal…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. Product Usage - The Hoffmann LRF System is indicated in pediatric patien…

Stryker GmbH

FDA Devices Moderate Nov 7, 2018

Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device tha…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Nov 7, 2018

Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used in radiographic and tomographic ex…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Nov 7, 2018

EVO Excel, Emission Computed Tomographic System, Material Number 10910501

Siemens Medical Solutions USA, Inc.

FDA Devices Moderate Nov 7, 2018

BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments

Leica Microsystems, Inc.

FDA Devices Moderate Nov 7, 2018

Zilver 518 Biliary Stent 4mm x 80mm, Catalog Number: ZIB5-125-4.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pall…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palli…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectiona…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Nov 7, 2018

Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-80-12.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pal…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient thr…

Baxter Healthcare Corporation

FDA Devices Moderate Nov 7, 2018

Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-125-12.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pa…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) central venous a…

Arrow International Inc

FDA Devices Moderate Nov 7, 2018

Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 REF: 3748GB. Product Usage - Impak Elastic Acrylic Resin Liquid, Use…

CMP Industries, Llc

FDA Devices Moderate Nov 7, 2018

Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palli…

Cook Medical Incorporated

FDA Devices Low Nov 7, 2018

Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software v4.2.1), Beckman Coulter, Inc. The iPAW ((intelligent Peri-Anal…

Beckman Coulter Inc.

FDA Devices Moderate Nov 7, 2018

Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used for radiographic and tomog…

Siemens Medical Solutions USA, Inc

FDA Devices Low Nov 7, 2018

Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software v4.2.1), Part No. A94144, Beckman Coulter, Inc. The So…

Beckman Coulter Inc.

FDA Devices Moderate Nov 7, 2018

FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test kit)/ 008…

BioFire Diagnostics, LLC

FDA Devices Moderate Nov 7, 2018

RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.

RAYSEARCH LABORATORIES AB

FDA Devices Moderate Nov 7, 2018

Zilver 518 Biliary Stent 4mm x 60mm, Catalog Number: ZIB5-125-4.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pall…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance photometer …

Roche Diagnostics Corporation

FDA Devices Moderate Nov 7, 2018

Zilver 518 Biliary Stent 5mm x 20mm, Catalog Number: ZIB5-125-5.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pall…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-125-12.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pa…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient th…

Baxter Healthcare Corporation

FDA Devices Moderate Nov 7, 2018

Zilver 518 Biliary Stent 5mm x 40mm, Catalog Number: ZIB5-125-5.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pall…

Cook Medical Incorporated

FDA Devices Low Nov 7, 2018

Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckman Coulter Biomedical GmbH The iPAW 4.2 User Kit (PN B73489) includes …

Beckman Coulter Inc.

FDA Devices Moderate Nov 7, 2018

Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. Product Usage - The Hoffmann LRF System is indicated in pediatric patien…

Stryker GmbH

FDA Devices Moderate Nov 7, 2018

Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-125-4.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pall…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Ima…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Nov 7, 2018

Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-80-14.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pal…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-125-12.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pa…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-sec…

Philips Medical Systems (Cleveland) Inc

CPSC Moderate Nov 7, 2018

Kubota Recalls Mowers and Compact Tractors Due to Burn Hazard (Recall Alert)

Kubota Manufacturing of America Corporation, of Gainesville, Ga.

NHTSA Critical Nov 6, 2018

FORD 2015-2018: SEATS

FORD

NHTSA Critical Nov 6, 2018

LOTUS 2018: STEERING

LOTUS

CPSC Moderate Nov 1, 2018

Black & Decker Recalls Hammer Drills Due to Injury Hazard

CPSC Moderate Nov 1, 2018

MCS Industries Recalls Glacier Bay Medicine Cabinets Due to Laceration Hazard; Sold Exclusively at The Home Depot

CPSC Moderate Nov 1, 2018

Pain Relief Naturally Recalls Pain and Itch Relief Creams, Sprays and Gels Due to Failure to Meet Child Resistant Closure Requirement; Risk of Poison…

Ridge Properties, DBA Pain Relief Naturally, of Salem, Ore.

NHTSA Critical Nov 1, 2018

MACK 2019: STEERING

MACK

NHTSA Critical Nov 1, 2018

ACURA,HONDA 2016-2019: SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS:DISC:CALIPER

ACURA,HONDA

NHTSA Critical Nov 1, 2018

FORD,LINCOLN,MERCURY 2010-2012: AIR BAGS:FRONTAL:PASSENGER SIDE:INFLATOR MODULE

FORD,LINCOLN,MERCURY

NHTSA Critical Nov 1, 2018

BUICK,CHEVROLET 2019: AIR BAGS

BUICK,CHEVROLET

FDA Food Moderate Oct 31, 2018

Fire-Roasted Home-Style Green Pepper Strips;: Sold in 20 lb. containers. Brand Name: Jon-Lin¿

McCain Foods USA

FDA Food Moderate Oct 31, 2018

Fire-Roasted 1/2" Diced Onions; Sold in 25 lb. containers. Brand Name:Jon-Lin¿

McCain Foods USA

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