PlainRecalls

2018 Recalls

7,717 recalls · Page 102 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 0 critical, 48 moderate, and 2 lower-severity recalls. The page references 19 distinct recalling firms operating in 1 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (50), 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 May 9, 2018

SOMATOM Spirit Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 9, 2018

708033 URODiagnost As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Perform…

Philips Medical Systems Nederlands

FDA Devices Moderate May 9, 2018

StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-016500; SBP-016605; SBP-020425 GPN : G52607; G52605; G52606; G52609; G52…

Cook Inc.

FDA Devices Moderate May 9, 2018

SOMATOM Sensation Open Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 9, 2018

Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood an…

Cardinal Health 200, LLC

FDA Devices Moderate May 9, 2018

SOMATOM Scope Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 9, 2018

cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical…

Roche Diagnostics Corporation

FDA Devices Moderate May 9, 2018

Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the …

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 9, 2018

StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020

Cook Inc.

FDA Devices Moderate May 9, 2018

StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044

Cook Inc.

FDA Devices Moderate May 9, 2018

cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 The Roche Diagnostics Omni S Analyzer is a fully automated critica…

Roche Diagnostics Corporation

FDA Devices Moderate May 9, 2018

Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 9, 2018

Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mu…

IntroMedic Co., Ltd.

FDA Devices Moderate May 9, 2018

Beijing Syntech Laser UL C02 Laser surgical lasers

Beijing Syntech Laser Co., Ltd

FDA Devices Moderate May 9, 2018

SOMATOM Sensation 64 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 9, 2018

WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used …

Beaver-Visitec International Inc.

FDA Devices Moderate May 9, 2018

SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 9, 2018

Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 9, 2018

MultiDiagnost Eleva 708036 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be…

Philips Medical Systems Nederlands

FDA Devices Moderate May 9, 2018

Beijing Syntech Laser Diode Laser surgical lasers

Beijing Syntech Laser Co., Ltd

FDA Devices Moderate May 9, 2018

SOMATOM Perspective Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 9, 2018

Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.

Siemens Medical Solutions USA, Inc.

FDA Devices Moderate May 9, 2018

Beijing Syntech Laser UL Station surgical lasers

Beijing Syntech Laser Co., Ltd

FDA Devices Moderate May 9, 2018

MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography a…

Philips Medical Systems Nederlands

FDA Devices Moderate May 9, 2018

Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Ce…

PerkinElmer Life and Analytical Sciences, Wallac, OY

FDA Devices Moderate May 9, 2018

6381 M-1 Cot Fastener, catalog no. 6381000000

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate May 9, 2018

Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 9, 2018

Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers

Beijing Syntech Laser Co., Ltd

FDA Devices Moderate May 9, 2018

Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented prosthesis The device is used in t…

Zimmer Biomet, Inc.

FDA Devices Moderate May 9, 2018

Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net. Wt. 4 fl. oz./118mL, Catalog No. NSP-04 The product is a …

Conseal International, Inc.

FDA Devices Moderate May 9, 2018

SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 9, 2018

MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and…

Hitachi Ltd., Medical System Operations Group

FDA Devices Moderate May 9, 2018

SOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 9, 2018

MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography a…

Philips Medical Systems Nederlands

FDA Devices Moderate May 9, 2018

Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and…

Philips Medical Systems Nederlands

FDA Devices Low May 9, 2018

BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829

Becton Dickinson & Co.

FDA Devices Moderate May 9, 2018

HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), SL3000 (b) Elasto-Gel(TM), SL3000LV (c) Elasto…

Southwest Technologies Inc

FDA Devices Moderate May 9, 2018

StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034

Cook Inc.

FDA Devices Moderate May 9, 2018

Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers

Beijing Syntech Laser Co., Ltd

FDA Devices Moderate May 9, 2018

Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis…

Zimmer Biomet, Inc.

FDA Devices Moderate May 9, 2018

SOMATOM Scope Power Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 9, 2018

MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Pe…

Philips Medical Systems Nederlands

FDA Devices Low May 9, 2018

Alere iScreen Dx Urine Drug Screen Card

Ameditech Inc

FDA Devices Moderate May 9, 2018

StoneBreaker Probe Cap, Catalog number:SBA-PC; GPN: G52601; UDI:(01)00827002526013

Cook Inc.

FDA Devices Moderate May 9, 2018

HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), TM7006 (b) Elasto-Gel(TM), TM7006LV (c) Elasto-Ge…

Southwest Technologies Inc

FDA Devices Moderate May 9, 2018

SOMATOM Emotion 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 9, 2018

SOMATOM Perspective 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 9, 2018

5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840 Product Usage: The Apple-Hunt Secondary …

CooperSurgical, Inc.

FDA Devices Moderate May 9, 2018

SOMATOM Emotion Duo (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 9, 2018

SOMATOM Emotion 6 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.

Siemens Medical Solutions USA, 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