PlainRecalls

2019 Recalls

6,365 recalls · Page 5 of 128

2019 Recall Year Insight

Federal agencies issued 6,365 product recalls indexed by PlainRecalls in calendar year 2019. That represents about 7.58% 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 2019.

On this page of 50 records, severity classification shows 2 critical, 48 moderate, and 0 lower-severity recalls. The page references 20 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, 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 Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.

Maquet Cardiovascular Us Sales, Llc

FDA Devices Moderate Dec 18, 2019

Healix Knotless ADV BR 4.75 Suture Anchor

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

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

Radiofrequency Grounding Pad, REF RF-DGP-L

Abbott Medical

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000

GETINGE US SALES LLC

FDA Devices Moderate Dec 18, 2019

Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517

Medtronic Navigation, Inc.

FDA Devices Moderate Dec 18, 2019

Ligamax 5 mm Endoscopic Multiple Clip Applier

Ethicon Endo-Surgery Inc

FDA Devices Moderate Dec 18, 2019

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences Corp.

FDA Devices Moderate Dec 18, 2019

Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970

CP Medical 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

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 Critical Dec 18, 2019

CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.

Cook Inc.

FDA Devices Critical Dec 18, 2019

CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.

Cook Inc.

FDA Devices Moderate Dec 18, 2019

P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only

Paragon 28, Inc.

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 o…

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 C…

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 bio…

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 electrod…

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 …

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…

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 s…

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…

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 s…

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.

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: CPSC + NHTSA + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2019