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.
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
Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
Gyrus ACMI, Inc.
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left, Part No. LJU210T
Integra LifeSciences Corp.
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
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
Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T
Integra LifeSciences Corp.
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, Part No. LJU213T
Integra LifeSciences Corp.
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
BIOPHEN UFH Control C1, REF 224101
Aniara Diagnostica LLC
Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T
Integra LifeSciences Corp.
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC
Gyrus ACMI, Inc.
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, Part No. LJU202T
Integra LifeSciences Corp.
Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnosti…
Roche Diagnostics Corporation
14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
Medical Components, Inc dba MedComp
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
Gyrus ACMI, Inc.
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.
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
Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification …
bioMerieux, Inc.
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.
Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T
Integra LifeSciences Corp.
BIOPHEN LMWH Control C4, REF 224201
Aniara Diagnostica LLC
Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T
Integra LifeSciences Corp.
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.
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, Part No. LJU211T
Integra LifeSciences Corp.
Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T
Integra LifeSciences Corp.
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.
Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
Gyrus ACMI, Inc.
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.
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.
Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T
Integra LifeSciences Corp.
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
Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T
Integra LifeSciences Corp.
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823T
Integra LifeSciences Corp.
Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.
Wilson-Cook Medical Inc.
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T
Integra LifeSciences Corp.
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.
Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T
Integra LifeSciences Corp.
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T
Integra LifeSciences Corp.
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.
Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS
Gyrus ACMI, Inc.
Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T
Integra LifeSciences Corp.
Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vas…
GE Healthcare, LLC
BIOPHEN UFH Control C2, REF 223901
Aniara Diagnostica LLC
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
Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T
Integra LifeSciences Corp.
Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T
Integra LifeSciences Corp.
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
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
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
Gyrus ACMI, Inc.
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.
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
Read our methodology — how this data is sourced, computed, and verified.