PlainRecalls

2019 Recall Year Insight

Federal agencies issued 7,611 product recalls indexed by PlainRecalls in calendar year 2019. That represents about 7.29% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 20.9 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 153 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 2019.

On this page of 50 records, severity classification shows 3 critical, 47 moderate, and 0 lower-severity recalls. The page references 18 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 2019 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 Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of post-operative sensitivity.

Young Dental Manufacturing Co, LLC

FDA Devices Moderate Dec 18, 2019

Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma Catalog number: 07026773190

Roche Diagnostics Operations, Inc.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly

LivaNova USA Inc

FDA Devices Moderate Dec 18, 2019

BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polymer Refine Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.

Leica Microsystems, Inc.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrodes. Order No. D5000, Part No. PN-1720 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrode. The Wave Prep¿ cups are a component in the Subject Kit.

Neuronetrix Solutions, LLC dba Cognision

FDA Devices Moderate Dec 18, 2019

iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

Conformis, Inc.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings. The Opti

The Binding Site Group, Ltd.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.

Boston Scientific Corporation

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product Usage: The SKINFUSE Rescue Calming Complex is intend to be used to soothe and calm skin (cosmetic). The SKINFUSE LIFT HG is a hydrogel wound dressing to protect against abrasion and friction during the microneedling procedure.

Bellus Medical

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.

Boston Scientific Corporation

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

MRIdian Linac Radiation Therapy System Model 10000 and 20000

Viewray, Inc.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096

Encore Medical, Lp

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Critical Dec 18, 2019

CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.

Cook Inc.

FDA Devices Critical Dec 18, 2019

CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.

Cook Inc.

FDA Devices Moderate Dec 18, 2019

Monaco Radiation Treatment Planning System (RTP) System

Elekta Inc

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1) Volcano Imaging System s5i, Part #807400001; (2) s5ix Imaging System with s5iz PC Workstation Refurbished, Part#807400001 R and 807401200; (3) s5i Imaging System, Part#806300003; (4) s5i Imaging System, Part#5322466; (5) s5x Imaging System, Part#807300001; (6) s5x Imaging System Refurbished, Pat#807300001 R; (7) s5 Imaging System Refurbished, Part#

Volcano Corporation

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108

Medtronic Navigation, Inc.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

Healix Knotless ADV BR 5.5 Suture Anchor

DePuy Mitek, Inc., a Johnson & Johnson Co.

FDA Devices Moderate Dec 18, 2019

Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943

Medtronic Navigation, Inc.

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Critical Dec 18, 2019

Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

Smiths Medical ASD Inc.

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2019 with 2018 →

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 2019

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 2019 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.