PlainRecalls

2019 Recalls

7,396 recalls · Page 109 of 148

2019 Recall Year Insight

Federal agencies issued 7,396 product recalls indexed by PlainRecalls in calendar year 2019. That represents about 8.81% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 20.3 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 148 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 6 critical, 41 moderate, and 3 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 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, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Critical Apr 24, 2019

Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Nav…

Brainlab AG

FDA Devices Moderate Apr 24, 2019

Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA

Gyrus ACMI, Inc.

FDA Devices Moderate Apr 24, 2019

Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left, Part No. LJU210T

Integra LifeSciences Corp.

FDA Devices Moderate Apr 24, 2019

A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condition where patient warming…

Pintler Medical LLC

FDA Devices Moderate Apr 24, 2019

Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Rob…

Medrobotics Corporation

FDA Devices Moderate Apr 24, 2019

Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T

Integra LifeSciences Corp.

FDA Devices Moderate Apr 24, 2019

Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, Part No. LJU213T

Integra LifeSciences Corp.

FDA Devices Moderate Apr 24, 2019

Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intend…

Philips Medical Systems Nederlands

FDA Devices Low Apr 24, 2019

BIOPHEN UFH Control C1, REF 224101

Aniara Diagnostica LLC

FDA Devices Moderate Apr 24, 2019

Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T

Integra LifeSciences Corp.

FDA Devices Moderate Apr 24, 2019

Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC

Gyrus ACMI, Inc.

FDA Devices Moderate Apr 24, 2019

Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, Part No. LJU202T

Integra LifeSciences Corp.

FDA Devices Moderate Apr 24, 2019

Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnosti…

Roche Diagnostics Corporation

FDA Devices Moderate Apr 24, 2019

14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422

Medical Components, Inc dba MedComp

FDA Devices Moderate Apr 24, 2019

Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS

Gyrus ACMI, Inc.

FDA Devices Critical Apr 24, 2019

icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration sets. The…

ICU Medical, Inc.

FDA Devices Moderate Apr 24, 2019

Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer rec…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Apr 24, 2019

Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification …

bioMerieux, Inc.

FDA Devices Critical Apr 24, 2019

SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer D…

ICU Medical, Inc.

FDA Devices Moderate Apr 24, 2019

Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T

Integra LifeSciences Corp.

FDA Devices Low Apr 24, 2019

BIOPHEN LMWH Control C4, REF 224201

Aniara Diagnostica LLC

FDA Devices Moderate Apr 24, 2019

Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T

Integra LifeSciences Corp.

FDA Devices Moderate Apr 24, 2019

syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analy…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Apr 24, 2019

Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, Part No. LJU211T

Integra LifeSciences Corp.

FDA Devices Moderate Apr 24, 2019

Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T

Integra LifeSciences Corp.

FDA Devices Critical Apr 24, 2019

icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfe…

ICU Medical, Inc.

FDA Devices Moderate Apr 24, 2019

Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS

Gyrus ACMI, Inc.

FDA Devices Critical Apr 24, 2019

icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transf…

ICU Medical, Inc.

FDA Devices Critical Apr 24, 2019

icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial…

ICU Medical, Inc.

FDA Devices Moderate Apr 24, 2019

Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T

Integra LifeSciences Corp.

FDA Devices Moderate Apr 24, 2019

Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a fully automated chemistry analyzer allowing rand…

Abbott Gmbh & Co. KG

FDA Devices Moderate Apr 24, 2019

Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T

Integra LifeSciences Corp.

FDA Devices Moderate Apr 24, 2019

Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823T

Integra LifeSciences Corp.

FDA Devices Moderate Apr 24, 2019

Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.

Wilson-Cook Medical Inc.

FDA Devices Moderate Apr 24, 2019

Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T

Integra LifeSciences Corp.

FDA Devices Moderate Apr 24, 2019

IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of dig…

Topcon Medical Systems, Inc.

FDA Devices Moderate Apr 24, 2019

Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T

Integra LifeSciences Corp.

FDA Devices Moderate Apr 24, 2019

Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T

Integra LifeSciences Corp.

FDA Devices Moderate Apr 24, 2019

PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardi…

Ethicon, Inc.

FDA Devices Moderate Apr 24, 2019

Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS

Gyrus ACMI, Inc.

FDA Devices Moderate Apr 24, 2019

Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T

Integra LifeSciences Corp.

FDA Devices Moderate Apr 24, 2019

Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vas…

GE Healthcare, LLC

FDA Devices Low Apr 24, 2019

BIOPHEN UFH Control C2, REF 223901

Aniara Diagnostica LLC

FDA Devices Moderate Apr 24, 2019

Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 722003 Allura Xper FD10 722005 Allura Xper…

Philips Medical Systems Nederlands

FDA Devices Moderate Apr 24, 2019

Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T

Integra LifeSciences Corp.

FDA Devices Moderate Apr 24, 2019

Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T

Integra LifeSciences Corp.

FDA Devices Moderate Apr 24, 2019

BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to the stabilit…

Bioventus, LLC

FDA Devices Moderate Apr 24, 2019

Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing ra…

Abbott Gmbh & Co. KG

FDA Devices Moderate Apr 24, 2019

Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS

Gyrus ACMI, Inc.

FDA Devices Moderate Apr 24, 2019

VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 UND VICRYL PLUS SUTURE 18"(45CM) 0 VIO VICRYL PLUS SUT…

Ethicon, 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 — consumer product and vehicle recall feeds for 2019