PlainRecalls

2018 Recalls

7,717 recalls · Page 80 of 155

2018 Recall Year Insight

Federal agencies issued 7,717 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 9.19% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 21.1 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 155 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 25 distinct recalling firms operating in 4 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (45), FDA Drug (4), FDA Food (1), 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 Food Critical Jun 13, 2018

WATAN DRY FRUITS PREMIUM QUALITY NATURAL DRIED APRICOT WITH PITT, NET WT. 1 LB, and 0.50 LB, PRODUCE OF PAKISTAN, IMPORT BY: GLOBAL COMMODITIES INC. …

Global Commodities Inc

FDA Drug Low Jun 13, 2018

Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pha…

Jubilant Cadista Pharmaceuticals, Inc.

FDA Drug Low Jun 13, 2018

Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Green…

Pharmaceutical Associates Inc

FDA Drug Moderate Jun 13, 2018

Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Manufactured…

Apotex Inc.

FDA Drug Critical Jun 13, 2018

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (NDC 0409-1782-03) and 10 count …

HOSPIRA INC, LAKE FOREST

FDA Devices Moderate Jun 13, 2018

Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011C

Orthofix, Inc

FDA Devices Moderate Jun 13, 2018

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product Usage: The Baxter SIGMA Spectrum Infus…

Baxter Healthcare Corporation

FDA Devices Critical Jun 13, 2018

Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / directio…

Draeger Medical Systems, Inc.

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001)

Orthofix, Inc

FDA Devices Moderate Jun 13, 2018

Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images…

GE Healthcare

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hex…

Orthofix Srl

FDA Devices Moderate Jun 13, 2018

RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.

Randox Laboratories

FDA Devices Moderate Jun 13, 2018

L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L); b) Right (003-E-00001R)

Orthofix, Inc

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated t…

Fresenius Medical Care Renal Therapies Group, LLC

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK ¿HCG; Part Number: 025261 Assay, Reproductive Hormone

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-009C

Orthofix, Inc

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device is designed to be used as a port of …

Stryker Corporation

FDA Devices Moderate Jun 13, 2018

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB Product Usage: The Baxter SIGMA Sp…

Baxter Healthcare Corporation

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)

C.R. Bard, Inc.

FDA Devices Moderate Jun 13, 2018

Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient throu…

CareFusion 303, Inc.

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker

Tosoh Bioscience Inc

FDA Devices Critical Jun 13, 2018

Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction…

Draeger Medical Systems, Inc.

FDA Devices Moderate Jun 13, 2018

BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, Catalog No. 367986

Becton Dickinson & Company

FDA Devices Moderate Jun 13, 2018

Bivona¿ Tracheostomy Tube Tracheostomy Tubes

Smiths Medical ASD Inc.

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number): a) Small/0MM Step/Left (002-C-01000L); b)…

Orthofix, Inc

FDA Devices Moderate Jun 13, 2018

Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and va…

Invivo Corporation

FDA Devices Moderate Jun 13, 2018

Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and li…

SANTA JOY ORNAMENT & GIFTWARE CO

FDA Devices Moderate Jun 13, 2018

fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner roo…

NordicNeuroLab AS

FDA Devices Moderate Jun 13, 2018

Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible …

Hobbs Medical, Inc.

FDA Devices Low Jun 13, 2018

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992

Datascope Corporation

FDA Devices Moderate Jun 13, 2018

MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tun…

MicroAire Surgical Instruments, LLC

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be…

MEDTECH SAS

FDA Devices Moderate Jun 13, 2018

CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020); b) Medium (002-G-01025); c) Large (002-G-01…

Orthofix, Inc

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001); b) Large (003-B-02001)

Orthofix, Inc

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker

Tosoh Bioscience 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