PlainRecalls

2018 Recall Year Insight

Federal agencies issued 7,928 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.59% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 21.7 recalls per day across the FDA, CPSC, USDA FSIS, 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 159 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, 44 moderate, and 6 lower-severity recalls. The page references 26 distinct recalling firms operating in 3 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (33), FDA Drug (17), 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, USDA FSIS, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Low Aug 8, 2018

Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01

Lupin Pharmaceuticals Inc.

FDA Drug Moderate Aug 8, 2018

Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-05.

West-Ward Columbus Inc

FDA Drug Moderate Aug 8, 2018

Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.

PFIZER

FDA Drug Moderate Aug 8, 2018

Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701

RemedyRepack Inc.

FDA Drug Moderate Aug 8, 2018

Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-50.

West-Ward Columbus Inc

FDA Drug Moderate Aug 8, 2018

Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.

Bryant Ranch Prepack Inc.

FDA Drug Low Aug 8, 2018

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10 and b) 36000-002-06.

Renaissance Lakewood, LLC

FDA Drug Moderate Aug 8, 2018

Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.

Bryant Ranch Prepack Inc.

FDA Drug Moderate Aug 8, 2018

Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01.

Hetero Labs, Ltd. - Unit III

FDA Drug Moderate Aug 8, 2018

Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with 343 on one side and HH on the other side.

H J Harkins Company Inc dba Pharma Pac

FDA Drug Moderate Aug 8, 2018

Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NY 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-0430-04

MAJOR PHARMACEUTICALS

FDA Drug Low Aug 8, 2018

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06.

Renaissance Lakewood, LLC

FDA Drug Moderate Aug 8, 2018

Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701

RemedyRepack Inc.

FDA Drug Moderate Aug 8, 2018

Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-407-01.

VENSUN PHARMACEUTICALS INC

FDA Drug Low Aug 8, 2018

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-002-10.

Renaissance Lakewood, LLC

FDA Drug Moderate Aug 8, 2018

Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-408-01.

VENSUN PHARMACEUTICALS INC

FDA Drug Moderate Aug 8, 2018

Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.

Bryant Ranch Prepack Inc.

FDA Devices Moderate Aug 8, 2018

FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)

Stryker Neurovascular

FDA Devices Moderate Aug 8, 2018

MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.

Integra LifeSciences Corp.

FDA Devices Moderate Aug 8, 2018

Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable Middle Ear Hearing Device.

Envoy Medical Corporation

FDA Devices Moderate Aug 8, 2018

CT Goldseal Optima CT 600

GE Healthcare, LLC

FDA Devices Moderate Aug 8, 2018

VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2

LivaNova USA Inc

FDA Devices Moderate Aug 8, 2018

Cayenne Medical Inc.

FDA Devices Moderate Aug 8, 2018

XLTEK EMU40EX EEG Headbox

Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

FDA Devices Moderate Aug 8, 2018

Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK.

GE Healthcare, LLC

FDA Devices Moderate Aug 8, 2018

1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05, c) DRC-002-06, d) DRC-002-08,

Galt Medical Corporation

FDA Devices Moderate Aug 8, 2018

Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.

Merge Healthcare, Inc.

FDA Devices Moderate Aug 8, 2018

Discovery MI Digital Ready

GE Healthcare, LLC

FDA Devices Moderate Aug 8, 2018

Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,

Galt Medical Corporation

FDA Devices Moderate Aug 8, 2018

MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.

Integra LifeSciences Corp.

FDA Devices Moderate Aug 8, 2018

Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46

Galt Medical Corporation

FDA Devices Moderate Aug 8, 2018

SOMATOM Emotion 6 (Model 10165888)

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Aug 8, 2018

Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22

GE Healthcare, LLC

FDA Devices Moderate Aug 8, 2018

Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055

Galt Medical Corporation

FDA Devices Moderate Aug 8, 2018

Optima CT 520

GE Healthcare, LLC

FDA Devices Moderate Aug 8, 2018

Optima CT 540

GE Healthcare, LLC

FDA Devices Moderate Aug 8, 2018

Nicolet¿ Ambulatory EEG

Natus Neurology Inc

FDA Devices Low Aug 8, 2018

Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540

Diamedix Corporation

FDA Devices Low Aug 8, 2018

Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640

Diamedix Corporation

FDA Devices Moderate Aug 8, 2018

1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b) KIT-075-03

Galt Medical Corporation

FDA Devices Moderate Aug 8, 2018

1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36; 2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog #: a) CLI-105-14; 3) AngioGate HV Introducer Kit, Sterile EO, Catalog #: a) KCL-102-05; b) KCL-102-07 4) VSI Micro-HV Introducer Kit, Sterile EO, Catalog #: a) CLI-800-33; b) CLI-810-16;

Galt Medical Corporation

FDA Devices Moderate Aug 8, 2018

SOMATOM Perspective 16 (Model 10891666)

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Aug 8, 2018

SOMATOM Perspective (Model 10495568)

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Aug 8, 2018

Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955

Covidien LLC

FDA Devices Moderate Aug 8, 2018

SOMATOM Scope Power (Model 10967888)

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Aug 8, 2018

MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.

Beckman Coulter Inc.

FDA Devices Moderate Aug 8, 2018

Revolution CT 160 1.5D STD WAUK

GE Healthcare, LLC

FDA Devices Moderate Aug 8, 2018

ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117

ELITech Clinical Systems SAS

FDA Devices Moderate Aug 8, 2018

EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.

QIAGEN

FDA Devices Moderate Aug 8, 2018

MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.

Integra LifeSciences Corp.

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: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2018

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