PlainRecalls

2018 Recalls

6,355 recalls · Page 34 of 128

2018 Recall Year Insight

Federal agencies issued 6,355 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.57% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 17.4 recalls per day across the FDA, CPSC, NHTSA, and USDA FSIS 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 128 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 9 critical, 39 moderate, and 2 lower-severity recalls. The page references 22 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 (48), CPSC (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, NHTSA, or USDA FSIS for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate Sep 26, 2018

URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM373DSAA, P…

Biocare Medical, LLC

FDA Devices Moderate Sep 26, 2018

Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number 102201100880TY Product Usage: This is sterile, single use, two-way silicone Fo…

Degania Silicone, Ltd.

FDA Devices Moderate Sep 26, 2018

Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour Plus LINK 2.4 wireless blood glucose …

Medtronic Inc.

FDA Devices Critical Sep 26, 2018

ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use.

Ventana Medical Systems Inc

FDA Devices Moderate Sep 26, 2018

Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems

Accuray Incorporated

FDA Devices Moderate Sep 26, 2018

Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP Product Usage: This is sterile, single use, two-way silicone Foley Cathet…

Degania Silicone, Ltd.

FDA Devices Moderate Sep 26, 2018

VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 41857…

bioMerieux, Inc.

FDA Devices Critical Sep 26, 2018

VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.

Ventana Medical Systems Inc

FDA Devices Moderate Sep 26, 2018

IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the prevention and treatment of all…

Stryker Medical Division of Stryker Corporation

FDA Devices Low Sep 26, 2018

VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic…

Ortho-Clinical Diagnostics

FDA Devices Moderate Sep 26, 2018

AIRO Mobile CT System Model # MobiCT-32

Mobius Imaging, LLC

FDA Devices Moderate Sep 26, 2018

Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD Product Usage: This is sterile, single use, two-way si…

Degania Silicone, Ltd.

FDA Devices Moderate Sep 26, 2018

Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP Product Usage: This is sterile, single use, two-way silicone Foley Cathet…

Degania Silicone, Ltd.

FDA Devices Critical Sep 26, 2018

iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.

Ventana Medical Systems Inc

FDA Devices Moderate Sep 26, 2018

Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter wit…

Degania Silicone, Ltd.

FDA Devices Moderate Sep 26, 2018

ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Sep 26, 2018

Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388

Invivo Corporation

FDA Devices Moderate Sep 26, 2018

Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use wit…

Mako Surgical Corporation

FDA Devices Moderate Sep 26, 2018

Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Product Usage: This is sterile, single use, two-way silicone Foley Cathete…

Degania Silicone, Ltd.

FDA Devices Moderate Sep 26, 2018

2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: …

Fresenius Medical Care Renal Therapies Group, LLC

FDA Devices Moderate Sep 26, 2018

Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter …

Degania Silicone, Ltd.

FDA Devices Critical Sep 26, 2018

CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohistochemistry (IHC) for in vitro diagnostic use.

Ventana Medical Systems Inc

FDA Devices Moderate Sep 26, 2018

2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: …

Fresenius Medical Care Renal Therapies Group, LLC

FDA Devices Moderate Sep 26, 2018

Temperature sensing catheter 16FR, Catalogue Number 102201101663NU Product Usage: This is sterile, single use, two-way silicone Foley Catheter wi…

Degania Silicone, Ltd.

FDA Devices Moderate Sep 26, 2018

PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro di…

Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc

FDA Devices Moderate Sep 26, 2018

Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with…

Degania Silicone, Ltd.

FDA Devices Moderate Sep 26, 2018

P400 PREM U/M 18FR TMPSNS, Item Code P4P18TS

COVIDIEN LLC

FDA Devices Low Sep 26, 2018

Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the labe…

Smiths Medical ASD Inc.

FDA Devices Critical Sep 26, 2018

ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use.

Ventana Medical Systems Inc

FDA Devices Moderate Sep 26, 2018

Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product Usage: This is sterile, single use, two-way silicone Foley Cathete…

Degania Silicone, Ltd.

FDA Devices Critical Sep 26, 2018

NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic use.

Ventana Medical Systems Inc

FDA Devices Moderate Sep 26, 2018

Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 26, 2018

400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD

COVIDIEN LLC

FDA Devices Moderate Sep 26, 2018

Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter wit…

Degania Silicone, Ltd.

FDA Devices Moderate Sep 26, 2018

Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter wit…

Degania Silicone, Ltd.

FDA Devices Critical Sep 26, 2018

CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296 Immunohistochemistr…

Ventana Medical Systems Inc

FDA Devices Moderate Sep 26, 2018

Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter wit…

Degania Silicone, Ltd.

FDA Devices Moderate Sep 26, 2018

Thermistor Foley catheter, nonsterile, Catalogue Number 102201101863MD Product Usage: This is sterile, single use, two-way silicone Foley Cathete…

Degania Silicone, Ltd.

FDA Devices Moderate Sep 26, 2018

400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD

COVIDIEN LLC

FDA Devices Moderate Sep 26, 2018

PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PAT…

Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc

FDA Devices Moderate Sep 26, 2018

Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Product Usage: This is sterile, single use, two-way silicone Foley Cathet…

Degania Silicone, Ltd.

FDA Devices Moderate Sep 26, 2018

Temperature sensing catheter 14FR, Catalogue Number 102203101463DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter wi…

Degania Silicone, Ltd.

FDA Devices Critical Sep 26, 2018

DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

Pro-Med Instruments Gmbh

FDA Devices Moderate Sep 26, 2018

sterEOS workstation

EOS Imaging

FDA Devices Moderate Sep 26, 2018

Foley Temperature Sensor Catheter 8FR, Catalogue Number 102201100880JP Product Usage: This is sterile, single use, two-way silicone Foley Cathete…

Degania Silicone, Ltd.

FDA Devices Moderate Sep 26, 2018

Temperature sensing catheter 14FR, Catalogue Number 102201101463NU Product Usage: This is sterile, single use, two-way silicone Foley Catheter wi…

Degania Silicone, Ltd.

FDA Devices Moderate Sep 26, 2018

ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging

Swissray Medical

FDA Devices Critical Sep 26, 2018

ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098 Immunohistochemistry (IHC) for in vitro diagnostic use.

Ventana Medical Systems Inc

CPSC Moderate Sep 26, 2018

Boy Scouts of America Recalls Neckerchief Slides Due to Violation of Federal Lead Content Ban

Strategic Orient Sourcing, of China

CPSC Moderate Sep 26, 2018

CFMOTO Recalls All-Terrain Vehicles Due to Fire Hazard

Zhejiang CFMOTO Power Co. Ltd., of China

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 + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2018