PlainRecalls

2018 Recalls

Compiled from official public sources by the editorial team.

7,795 recalls · Page 2 of 156

2018 Recall Year Insight

Federal agencies issued 7,795 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.66% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 21.4 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 156 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 1 critical, 45 moderate, and 4 lower-severity recalls. The page references 31 distinct recalling firms operating in 3 distinct product categories, with 46 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (44), FDA Drug (6), 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 Drug Moderate Dec 26, 2018

Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc.…

Cipla Limited

FDA Drug Moderate Dec 26, 2018

Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syrin…

Pharmedium Services, LLC

FDA Drug Low Dec 26, 2018

NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per ca…

VistaPharm, Inc.

FDA Drug Low Dec 26, 2018

Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 oz./128 g tube, Mfg. For Credentials Skincare Fort W…

CBI Laboratories, Inc.

FDA Drug Low Dec 26, 2018

Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in India for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430…

Glenmark Pharmaceuticals Inc., USA

FDA Drug Moderate Dec 26, 2018

Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories,…

Gordon Laboratories

FDA Devices Moderate Dec 26, 2018

ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing i…

Clark Laboratories, Inc. (dba,Trinity Biotech USA)

FDA Devices Moderate Dec 26, 2018

VITEK¿ 2 Systems Software Version 9.01 Update Kit.

bioMerieux, Inc.

FDA Devices Low Dec 26, 2018

RT-5100 Refractor, a component of the Epic-5100 System.

Nidek Inc.

FDA Devices Moderate Dec 26, 2018

Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, h…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Dec 26, 2018

Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.…

GE Healthcare, LLC

FDA Devices Moderate Dec 26, 2018

IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - Product Usage: The ORT200 and ORT300 ar…

Deerfield Imaging, Inc.

FDA Devices Moderate Dec 26, 2018

Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving nerve retracti…

Howmedica Osteonics Corp.

FDA Devices Moderate Dec 26, 2018

VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interes…

Ortho-Clinical Diagnostics

FDA Devices Moderate Dec 26, 2018

Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and intraoperativ…

Covidien LLC

FDA Devices Moderate Dec 26, 2018

Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 45356…

Philips Electronics North America Corporation

FDA Devices Moderate Dec 26, 2018

Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device Anti-Rot…

Zimmer Biomet, Inc.

FDA Devices Moderate Dec 26, 2018

VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical…

Ortho-Clinical Diagnostics

FDA Devices Moderate Dec 26, 2018

Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus antico…

Diagnostica Stago, Inc.

FDA Devices Moderate Dec 26, 2018

SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for th…

ICU Medical Inc

FDA Devices Moderate Dec 26, 2018

Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chr…

Clark Laboratories, Inc. (dba,Trinity Biotech USA)

FDA Devices Moderate Dec 26, 2018

Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT¿, EmpowerCTA¿ and EmpowerCTA¿+ Injector Systems SKU 0173…

Bracco Injeneering S.A.

FDA Devices Moderate Dec 26, 2018

Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exch…

Clark Laboratories, Inc. (dba,Trinity Biotech USA)

FDA Devices Moderate Dec 26, 2018

Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic …

Cardinal Health 200, LLC

FDA Devices Moderate Dec 26, 2018

Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, JHI-201 Ped…

Jarvik Heart Inc

FDA Devices Moderate Dec 26, 2018

Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and intraope…

Covidien LLC

FDA Devices Moderate Dec 26, 2018

Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic …

Cardinal Health 200, LLC

FDA Devices Moderate Dec 26, 2018

Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a…

Theragenics Corporation

FDA Devices Moderate Dec 26, 2018

Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic …

Cardinal Health 200, LLC

FDA Devices Moderate Dec 26, 2018

Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in percutaneous, laparoscopic, and intraop…

Covidien LLC

FDA Devices Moderate Dec 26, 2018

FoundationOne CDx Test Results

Foundation Medicine, Inc.

FDA Devices Moderate Dec 26, 2018

8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826

COVIDIEN LLC

FDA Devices Moderate Dec 26, 2018

Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glovessterile light brown colored surgeons gloves are a disposable device ma…

Cardinal Health 200, LLC

FDA Devices Moderate Dec 26, 2018

VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 Catalog #…

bioMerieux, Inc.

FDA Devices Moderate Dec 26, 2018

IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - Product Usage: The ORT200 and ORT300 are intended for …

Deerfield Imaging, Inc.

FDA Devices Critical Dec 26, 2018

Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilator Puritan …

COVIDIEN LLC

FDA Devices Moderate Dec 26, 2018

Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E

Fresenius Medical Care Renal Therapies Group, LLC

FDA Devices Moderate Dec 26, 2018

Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, …

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Dec 26, 2018

NexGen¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 NexGen Distal Femoral Augment …

Zimmer Biomet, Inc.

FDA Devices Moderate Dec 26, 2018

AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA)…

Tosoh Bioscience Inc

FDA Devices Moderate Dec 26, 2018

GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical la…

Advanced Instruments, LLC

FDA Devices Moderate Dec 26, 2018

Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller Stems are intended to reduce pa…

Zimmer GmbH

FDA Devices Moderate Dec 26, 2018

Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic …

Cardinal Health 200, LLC

FDA Devices Moderate Dec 26, 2018

Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List Numb…

Abbott Point Of Care Inc.

FDA Devices Moderate Dec 26, 2018

Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chr…

Clark Laboratories, Inc. (dba,Trinity Biotech USA)

FDA Devices Moderate Dec 26, 2018

VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interes…

Ortho-Clinical Diagnostics

FDA Devices Moderate Dec 26, 2018

Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Ind…

Mazor Robotics Ltd

FDA Devices Moderate Dec 26, 2018

Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchan…

Clark Laboratories, Inc. (dba,Trinity Biotech USA)

FDA Devices Moderate Dec 26, 2018

IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic exam…

Deerfield Imaging, Inc.

FDA Devices Moderate Dec 26, 2018

Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoag…

Diagnostica Stago, Inc.

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Figures cover calendar year 2018 across the FDA, CPSC 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 July 2026.