PlainRecalls

2019 Recalls

Compiled from official public sources by the editorial team.

7,480 recalls · Page 28 of 150

2019 Recall Year Insight

Federal agencies issued 7,480 product recalls indexed by PlainRecalls in calendar year 2019. That represents about 7.35% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 20.5 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 150 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 27 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 (49), CPSC (1), 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 Moderate Nov 6, 2019

TherMax Blood Warmer Unit

Baxter Healthcare Corporation

FDA Devices Moderate Nov 6, 2019

Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)…

Implant Direct Sybron Manufacturing, LLC

FDA Devices Moderate Nov 6, 2019

A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.

Alto Development Corp

FDA Devices Moderate Nov 6, 2019

PORT ACCESS INFUSION KIT - 1" NEEDLE Product Code: DYNDC2817

Centurion Medical Products Corporation

FDA Devices Moderate Nov 6, 2019

Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326320, REF 2632, STERILE:EO - Product Usage: prod…

Stryker Neurovascular

FDA Devices Moderate Nov 6, 2019

Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is i…

Mindray DS USA, Inc. dba Mindray North America

FDA Devices Moderate Nov 6, 2019

Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate Nov 6, 2019

Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, STERILE: EO - Product Usage: product is i…

Stryker Neurovascular

FDA Devices Moderate Nov 6, 2019

Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system c…

OrthoPediatrics Corp

FDA Devices Moderate Nov 6, 2019

Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is inte…

Mindray DS USA, Inc. dba Mindray North America

FDA Devices Moderate Nov 6, 2019

BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608

Becton Dickinson & Company

FDA Devices Moderate Nov 6, 2019

Maintenance Flush Kit/Blood Draw Product Code: DT19335

Centurion Medical Products Corporation

FDA Devices Moderate Nov 6, 2019

DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02

Valeritas, Incorporated

FDA Devices Moderate Nov 6, 2019

DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01

Valeritas, Incorporated

FDA Devices Moderate Nov 6, 2019

Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2

LABSTYLE INNOVATIONS

FDA Devices Moderate Nov 6, 2019

Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326520, REF 2652, STERILE: EO - Product Usage: p…

Stryker Neurovascular

FDA Devices Moderate Nov 6, 2019

Various products which were contract sterilized.

Anewmed Corporation

FDA Devices Moderate Nov 6, 2019

EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic sur…

Intuitive Surgical, Inc.

FDA Devices Moderate Nov 6, 2019

Kit, Port Access Product Code: DYNDC1582A

Centurion Medical Products Corporation

FDA Devices Moderate Nov 6, 2019

Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate Nov 6, 2019

A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or reconstruction of the sternum.

Alto Development Corp

FDA Devices Moderate Nov 6, 2019

Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is inten…

Mindray DS USA, Inc. dba Mindray North America

FDA Devices Moderate Nov 6, 2019

Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Product No. M00326510, REF 2651, STERILE:EO - Product Usage: product is int…

Stryker Neurovascular

FDA Devices Moderate Nov 6, 2019

Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642, STERILE: EO - Product Usage: p…

Stryker Neurovascular

FDA Devices Critical Nov 6, 2019

ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A

Ethicon Endo-Surgery Inc

FDA Devices Moderate Nov 6, 2019

SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22G x 120mm w/…

Pajunk GmbH

FDA Devices Moderate Nov 6, 2019

DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03

Valeritas, Incorporated

FDA Devices Moderate Nov 6, 2019

Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahesive 3…

ConvaTec, Inc

FDA Devices Moderate Nov 6, 2019

A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum.

Alto Development Corp

FDA Devices Critical Nov 6, 2019

ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A

Ethicon Endo-Surgery Inc

FDA Devices Moderate Nov 6, 2019

HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in th…

Hycor Biomedical LLC

FDA Devices Moderate Nov 6, 2019

SAROS Oxygen System Model 3000

Caire, Inc.

FDA Devices Moderate Nov 6, 2019

CardioLab/ComboLab Recording Systems

GE Healthcare, LLC

FDA Devices Moderate Nov 6, 2019

DEMO No Needle Corrugated Carton 30 U/D, Part Number 2260-02

Valeritas, Incorporated

FDA Devices Moderate Nov 6, 2019

A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruction of the sternum.

Alto Development Corp

FDA Devices Moderate Nov 6, 2019

Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery

Synthes (USA) Products LLC

FDA Devices Critical Nov 6, 2019

CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumpin…

Thoratec Switzerland GMBH

FDA Devices Moderate Nov 6, 2019

Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: product is inten…

Stryker Neurovascular

FDA Devices Moderate Nov 6, 2019

Port full Access Tray Product Code: DT19330

Centurion Medical Products Corporation

FDA Devices Moderate Nov 6, 2019

Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

Senseonics, Inc.

FDA Devices Moderate Nov 6, 2019

Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate Nov 6, 2019

Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326110, REF 2611, STERILE: EO - Product Usage: pro…

Stryker Neurovascular

FDA Devices Moderate Nov 6, 2019

Posey Connected Twice-As-Tough Cuffs

TIDI PRODUCTS

FDA Devices Moderate Nov 6, 2019

The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.

Draegar Medical Systems, Inc.

FDA Devices Moderate Nov 6, 2019

Accutorr 7 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is …

Mindray DS USA, Inc. dba Mindray North America

FDA Devices Moderate Nov 6, 2019

Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.

Cordis Corporation

FDA Devices Moderate Nov 6, 2019

SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The St¿ckert Heater-Cooler System is an independent (i.e. independ…

LivaNova USA Inc.

FDA Devices Moderate Nov 6, 2019

A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.

Alto Development Corp

FDA Devices Moderate Nov 6, 2019

Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonl…

OrthoPediatrics Corp

CPSC Moderate Nov 6, 2019

Skacel Collection Recalls FlipStix Knitting Needles Due to Laceration Hazard

Gustav Selter GmbH Co. & KG, of Germany

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Figures cover calendar year 2019 across the FDA, CPSC 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 July 2026.