PlainRecalls

2018 Recalls

7,717 recalls · Page 81 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 2 critical, 46 moderate, and 2 lower-severity recalls. The page references 17 distinct recalling firms operating in 4 distinct product categories, with 48 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (43), CPSC (5), NHTSA (2), 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 Devices Moderate Jun 13, 2018

ST-AIA PACK TU; Part Number: 025270 Assay, Thyroid

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002); c) Large (002-B-03…

Orthofix, Inc

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Jun 13, 2018

11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms

Ii - Vi Incorporated

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters…

NordicNeuroLab AS

FDA Devices Moderate Jun 13, 2018

Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010) b) D 3.2MM X 12MM (002-D-320…

Orthofix, Inc

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983

Becton Dickinson & Company

FDA Devices Moderate Jun 13, 2018

nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians a…

NordicNeuroLab AS

FDA Devices Low Jun 13, 2018

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588

Datascope Corporation

FDA Devices Moderate Jun 13, 2018

Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010) b) D 3.2MM X 12MM (002-E-32012)…

Orthofix, Inc

FDA Devices Moderate Jun 13, 2018

Restoris MCK Onlay Insert Extractor.

Mako Surgical Corporation

FDA Devices Moderate Jun 13, 2018

ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK FT3; Part Number: 025286 Assay, Thyroid

Tosoh Bioscience Inc

FDA Devices Low Jun 13, 2018

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490

Datascope Corporation

FDA Devices Moderate Jun 13, 2018

Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbers): a) D 2.7MM X 8MM (002-D-27008); b) D 2.7MM…

Orthofix, Inc

FDA Devices Moderate Jun 13, 2018

Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (0002-D-20008); b) D 2.0MM X 10MM (002-D-20…

Orthofix, Inc

FDA Devices Moderate Jun 13, 2018

VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit

VGI Medical, LLC

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK TT3; Part Number: 025282 Assay, Thyroid

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (002-E-20008); b) D 2.0MM X 10MM…

Orthofix, Inc

FDA Devices Moderate Jun 13, 2018

ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac Marker

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 12MM Spacer (003-H-12001); b) 15MM Spacer (003-H-15001); 20M…

Orthofix, Inc

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK Estradiol; Part Number: 025274 Assay, Reproductive Hormone

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 6MM Spacer (002-H-00006); b) 8MM Spacer (022-H-00008); c) 1…

Orthofix, Inc

FDA Devices Moderate Jun 13, 2018

Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 18MM (003-F-18001); b) 22MM (003-F-22001); c) 30MM (003-F-30001)

Orthofix, Inc

FDA Devices Moderate Jun 13, 2018

Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a) 3 Hole (003-D-01001); b) 4 Hole (003-D-02001); c) 6 Hole (0…

Orthofix, Inc

FDA Devices Moderate Jun 13, 2018

TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-F-01020); b) Medium (002-F-01025); c) Large (002-F-010…

Orthofix, Inc

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK BMG; Part Number:025259 Assay, Tumor Marker

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK C-Peptide II; Part Number: 025283 Assay, Diabetes

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 2.7MM X 8MM (002-E-27008), b) D 2.7MM X 10MM (002-E-27010)…

Orthofix, Inc

FDA Devices Moderate Jun 13, 2018

12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy syst…

Ion Beam Applications S.A.

FDA Devices Moderate Jun 13, 2018

Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C

Orthofix, Inc

FDA Devices Moderate Jun 13, 2018

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

GE Healthcare

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive Hormone

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive Hormone

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid

Tosoh Bioscience Inc

FDA Devices Moderate Jun 13, 2018

ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes

Tosoh Bioscience Inc

CPSC Moderate Jun 12, 2018

A&I Recalls Tractor Canopies Due To Injury Hazard

ATI Products Inc., a subsidiary of Deere & Company, of Moline, Ill.

CPSC Moderate Jun 12, 2018

Ashley Furniture Recalls Floor Lamps Due to Burn Hazard (Recall Alert)

DBA Export India PVT Ltd., of India

CPSC Moderate Jun 12, 2018

Ketra Recalls to Inspect Recessed Downlights Due to Electrical Shock Hazard

CPSC Moderate Jun 12, 2018

Lorex Recalls Three Models of Video Monitors Due to Burn Hazard

RDI Technology (Shenzhen) Co. Ltd, of China

CPSC Moderate Jun 12, 2018

Uttermost Recalls Mirrors, Art and Wall Decor Due to Injury Hazard

The Uttermost Company, of Rocky Mount, Va.

NHTSA Critical Jun 12, 2018

FORD,LINCOLN 2018: FUEL SYSTEM, GASOLINE:DELIVERY:FUEL PUMP

FORD,LINCOLN

NHTSA Critical Jun 12, 2018

LAMBORGHINI 2014: ENGINE AND ENGINE COOLING:ENGINE

LAMBORGHINI

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