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 8 critical, 42 moderate, and 0 lower-severity recalls. The page references 25 distinct recalling firms operating in 3 distinct product categories, with 45 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (44), NHTSA (5), 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, 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 Aug 14, 2019

LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for general patient population.

Centurion Medical Products Corporation

FDA Devices Moderate Aug 14, 2019

SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

SenTec AG

FDA Devices Moderate Aug 14, 2019

Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis and iron deficiency anemia.

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Aug 14, 2019

The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them. The system is a self-contained unit that consists of a light source unit and a single use catheter. The light source contains a microprocessor with software to provide safety features and a user-friendly interface. The laser operates by producing a high current discharge within a chamber that is filled with rare gases and

Ra Medical Systems Inc

FDA Devices Moderate Aug 14, 2019

HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.

Centurion Medical Products Corporation

FDA Devices Moderate Aug 14, 2019

Workstation, G2, Configured (P/N 000-0241)

Intellijoint Surgical, Inc.

FDA Devices Moderate Aug 14, 2019

VITROS 4600 Chemistry System, clinical chemistry analyzer

Ortho Clinical Diagnostics

FDA Devices Moderate Aug 14, 2019

Logolas Laser Projection Series

Gk Photonics Inc

FDA Devices Moderate Aug 14, 2019

EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 12G - REF ECP0112G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

Bard Peripheral Vascular Inc

FDA Devices Critical Aug 14, 2019

ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738

St Jude Medical Inc.

FDA Devices Moderate Aug 14, 2019

MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard Product Usage: The SONATATIi100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to p

MED-EL Elektromedizinische Gereate, Gmbh

FDA Devices Moderate Aug 14, 2019

Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.5g, For single use only, Part Number 20116 - Product Usage: Augmentation or reconstructive treatment of the alveolar ridge; Filling of infrabony periodontal defects; Filling of defects after root resection, apicoectomy and cystectomy; Filling of extraction sockets to enhance preservation of the alveolar ridge; Elevation of the maxillary sinus floor, etc.

Geistlich Pharma North America, Inc.

FDA Devices Moderate Aug 14, 2019

EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 12GV Upright (Vertical) - REF ECP0112GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

Bard Peripheral Vascular Inc

FDA Devices Critical Aug 14, 2019

ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615

St Jude Medical Inc.

FDA Devices Moderate Aug 14, 2019

DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means

DRG Instruments GmbH

FDA Devices Moderate Aug 14, 2019

iCT SP Model # 728311, computed tomography x-ray system

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Aug 14, 2019

14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialysis catheter

Medical Components, Inc dba MedComp

FDA Devices Moderate Aug 14, 2019

VITROS 4600 Chemistry System, clinical chemistry analyzer

Ortho Clinical Diagnostics

FDA Devices Moderate Aug 14, 2019

Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.

Olympus Corporation of the Americas

FDA Devices Moderate Aug 14, 2019

VITROS 350 Chemistry System, clinical chemistry analyzer

Ortho Clinical Diagnostics

FDA Devices Moderate Aug 14, 2019

EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 10G - REF ECP0110G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

Bard Peripheral Vascular Inc

FDA Devices Moderate Aug 14, 2019

Maxim Laser Projection Series

Gk Photonics Inc

FDA Devices Moderate Aug 14, 2019

Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows: (1) LIBERTY Line Cycler Set with Stay-safe connectors (Dual Patient Connector) Part Number: 050-87212 (2) LIBERTY Line Cycler Set with Stay-safe connectors (Single Patient Connector) Part Number: 050-87215 (3) LIBERTY Integrated Cycler Set with single Stay-safe patient connector and extended drain line Part Number: 050-87216

Fresenius Medical Care Renal Therapies Group, LLC

FDA Devices Moderate Aug 14, 2019

Lantis 6.1 Commander, Model # 5493072 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that patient, setting up and delivering the treatment fields and recording the delivered treatment. Treatstation supports auto sequencing, a process of automatically downloading a group of fields or segments from the verification and rec

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Aug 14, 2019

MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition

MED-EL Elektromedizinische Gereate, Gmbh

FDA Devices Moderate Aug 14, 2019

VITROS 5600 Integrated System, clinical chemistry analyzer

Ortho Clinical Diagnostics

FDA Devices Moderate Aug 14, 2019

Atom Laser Projection Series

Gk Photonics Inc

FDA Devices Moderate Aug 14, 2019

Ingenuity Core Model # 728321, computed tomography x-ray system

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Aug 14, 2019

14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter

Medical Components, Inc dba MedComp

FDA Devices Moderate Aug 14, 2019

SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.]

SenTec AG

FDA Devices Moderate Aug 14, 2019

CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for performing circumcision procedures on newborns.

Centurion Medical Products Corporation

FDA Devices Moderate Aug 14, 2019

STERILE FLUORO SSP TRAY Kit Code: MNS11605 - Product Usage: This kit is used for arthrogram injection and aspiration. The kits are used in the diagnostic section of the radiology department, by medical professionals in a clinical setting.

Centurion Medical Products Corporation

FDA Devices Moderate Aug 14, 2019

Vereos PET/CT Model # 882446, computed tomography x-ray system

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Aug 14, 2019

The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a software application that partners and their customers were given access to. Product Usage: This online portion of the Visibly Vision Test Solution is used to measure vision refraction.

Opternative Inc

FDA Devices Moderate Aug 14, 2019

Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.

Abbott Ireland Diagnostics Division

FDA Devices Moderate Aug 14, 2019

Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.

Medline Industries Inc

FDA Devices Moderate Aug 14, 2019

IQon Spectral CT Model # 728332, computed tomography x-ray system

Philips Medical Systems (Cleveland) Inc

FDA Devices Critical Aug 14, 2019

ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)

St Jude Medical Inc.

FDA Devices Moderate Aug 14, 2019

Lantis system (pre-2003), Model #5835991 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that patient, setting up and delivering the treatment fields and recording the delivered treatment. Treatstation supports auto sequencing, a process of automatically downloading a group of fields or segments from the verification and

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Aug 14, 2019

VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer

Ortho Clinical Diagnostics

FDA Devices Moderate Aug 14, 2019

ClubMax Laser Projection Series

Gk Photonics Inc

FDA Devices Moderate Aug 14, 2019

Spectrum Laser Projection Series

Gk Photonics Inc

FDA Devices Moderate Aug 14, 2019

CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product Usage:BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible

Biomet 3i, LLC

FDA Devices Moderate Aug 14, 2019

EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 10GV Upright (Vertical) - REF ECP0110GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

Bard Peripheral Vascular Inc

NHTSA No agency class Aug 14, 2019

BMW,MINI 2018-2019: STEERING:LINKAGES:TIE ROD ASSEMBLY

BMW,MINI

NHTSA No agency class Aug 14, 2019

BMW 2020: SEATS

BMW

NHTSA No agency class Aug 14, 2019

BMW 2019: HYBRID PROPULSION SYSTEM

BMW

NHTSA No agency class Aug 14, 2019

BMW 2018-2019: SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS:DISC:CALIPER

BMW

CPSC No agency class Aug 13, 2019

SunSetter Recalls Vinyl Covers for Motorized Awnings Due to Impact and Fall Hazards; One Death Reported (Recall Alert)

SunSetter Products LP, of Malden, Mass.

NHTSA No agency class Aug 13, 2019

KIA 2020: SEAT BELTS:REAR/OTHER

KIA

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.