PlainRecalls

2018 Recalls

Compiled from official public sources by the editorial team.

7,795 recalls · Page 18 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 4 critical, 43 moderate, and 3 lower-severity recalls. The page references 30 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 (37), FDA Drug (13), 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 Nov 14, 2018

BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in normject syringe) Repackaged by Avella Specialty Pharmacy, 24416 N 19th A…

Avella of Deer Valley, Inc. Store 38

FDA Drug Low Nov 14, 2018

Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90 mg, 120-count bottles, Rx only, Distributed by Orexigen therapeutics, I…

Orexigen Therapeutics, Inc.

FDA Drug Moderate Nov 14, 2018

Healthful Naturals DizziFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-204-02

Silver Star Brands

FDA Drug Moderate Nov 14, 2018

Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-06), 12 count (NDC 69761-187-12), and 30 count (NDC 69761-187-30) vial…

Qualgen, LLC

FDA Drug Moderate Nov 14, 2018

Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 12 count (NDC 69761-025-12), and 30 count (NDC 69761-025-30) vials, Rx…

Qualgen, LLC

FDA Drug Moderate Nov 14, 2018

Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-06), 12 count (NDC 69761-112-12), and 30 count (NDC 69761-112-30) vial…

Qualgen, LLC

FDA Drug Moderate Nov 14, 2018

Estradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06), 12 count (NDC 69761-006-12), and 30 count (NDC 69761-006-30) vials, Rx…

Qualgen, LLC

FDA Drug Moderate Nov 14, 2018

deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Made in the USA, Deb …

S.C. Johnson Professional

FDA Drug Moderate Nov 14, 2018

Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count (NDC 69761-010-12), and 30 count (NDC 69761-010-30) vials, Rx…

Qualgen, LLC

FDA Drug Moderate Nov 14, 2018

Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906 NDC 68703-206-02

Silver Star Brands

FDA Drug Moderate Nov 14, 2018

SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube (NDC 53329-…

Medline Industries Inc

FDA Drug Moderate Nov 14, 2018

Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection, Rx Only, Tailor Made Compounding, Nicholasville, K…

Tailor Made Compounding

FDA Drug Critical Nov 14, 2018

Native Remedies VertiFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-253-02

Silver Star Brands

FDA Devices Moderate Nov 14, 2018

Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Jo…

Howmedica Osteonics Corp.

FDA Devices Low Nov 14, 2018

R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971

R & D Systems, Inc.

FDA Devices Moderate Nov 14, 2018

Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra poplit…

Cordis Corporation

FDA Devices Moderate Nov 14, 2018

StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade sili…

Zimmer Biomet, Inc.

FDA Devices Moderate Nov 14, 2018

Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for the re-attachment of the bone flap…

Zimmer Biomet, Inc.

FDA Devices Moderate Nov 14, 2018

DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.

DT MedTech, LLC

FDA Devices Moderate Nov 14, 2018

Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension¿ EXL 200 00630414593579; Dimension¿ EXL with LM…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Critical Nov 14, 2018

CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog N…

Roche Diagnostics Corporation

FDA Devices Low Nov 14, 2018

Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL an…

Medtest Holdings, Inc.

FDA Devices Moderate Nov 14, 2018

CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic radiosurgery a…

Accuray Incorporated

FDA Devices Moderate Nov 14, 2018

Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345

Safe N Simple, LLC

FDA Devices Moderate Nov 14, 2018

VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative measur…

Ortho-Clinical Diagnostics

FDA Devices Moderate Nov 14, 2018

EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation and pu…

Qiagen Sciences LLC

FDA Devices Moderate Nov 14, 2018

ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental re…

Coltene Whaledent Inc

FDA Devices Critical Nov 14, 2018

REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicat…

OriGen Biomedical, Inc.

FDA Devices Moderate Nov 14, 2018

Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI70002000 OARM B…

Medtronic Navigation, Inc.-Littleton

FDA Devices Moderate Nov 14, 2018

Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref Number: 75-1040 Used for the re-attachment of the bone flap after a cran…

Zimmer Biomet, Inc.

FDA Devices Moderate Nov 14, 2018

DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.

DT MedTech, LLC

FDA Devices Moderate Nov 14, 2018

Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1040-12 Used for the re-attachment of the bone flap a…

Zimmer Biomet, Inc.

FDA Devices Moderate Nov 14, 2018

PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification…

Becton Dickinson & Company

FDA Devices Moderate Nov 14, 2018

Medtronic CareLink Encore 29901 Programmer

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate Nov 14, 2018

Liquid Cardiac Control, CQ5053

Randox Laboratories Ltd.

FDA Devices Critical Nov 14, 2018

TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for ster…

Oscor, Inc.

FDA Devices Moderate Nov 14, 2018

Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular…

AROA BIOSURGERY

FDA Devices Moderate Nov 14, 2018

Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFu…

CareFusion 303, Inc.

FDA Devices Moderate Nov 14, 2018

BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter), Catalog Number 383539 Product Usage: BD Nexiva Closed IV Cathet…

Becton Dickinson & Company

FDA Devices Moderate Nov 14, 2018

Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1020-12 Used for the re-attachment of the bone flap af…

Zimmer Biomet, Inc.

FDA Devices Moderate Nov 14, 2018

Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of the bone flap after a cranioto…

Zimmer Biomet, Inc.

FDA Devices Moderate Nov 14, 2018

Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315

Safe N Simple, LLC

FDA Devices Moderate Nov 14, 2018

Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various i…

GE Healthcare, LLC

FDA Devices Moderate Nov 14, 2018

Endoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular…

AROA BIOSURGERY

FDA Devices Moderate Nov 14, 2018

Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref Number: 75-1030 Used for the re-attachment of the bone flap after a cran…

Zimmer Biomet, Inc.

FDA Devices Moderate Nov 14, 2018

FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product Usage: Indicated for spinal i…

Integrity Implants Inc.

FDA Devices Moderate Nov 14, 2018

PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification St…

Becton Dickinson & Company

FDA Devices Moderate Nov 14, 2018

Medtronic CareLink 2090 Programmer

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate Nov 14, 2018

Liquid Cardiac Control, CQ5052

Randox Laboratories Ltd.

FDA Devices Moderate Nov 14, 2018

Liquid Cardiac Control, CQ5051

Randox Laboratories Ltd.

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.