PlainRecalls

2019 Recalls

6,365 recalls · Page 54 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 3 critical, 44 moderate, and 3 lower-severity recalls. The page references 25 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 Aug 14, 2019

SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014

MicroAire Surgical Instruments, LLC

FDA Devices Moderate Aug 14, 2019

Ingenuity Core128 Model # 728323, computed tomography x-ray system

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Aug 14, 2019

IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475…

Ideal Implant Incorporated

FDA Devices Moderate Aug 14, 2019

DAILY DRIVELINE KIT Kit Code: DM940 - 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

CIRCUMCISION TRAY Kit Code: CIT2245 - Product Usage: Kit is used for performing circumcision procedures on newborns.

Centurion Medical Products Corporation

FDA Devices Moderate Aug 14, 2019

VITROS 5600 Integrated System, clinical chemistry analyzer

Ortho Clinical Diagnostics

FDA Devices Moderate Aug 14, 2019

Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0…

ROi Consolidated Service Center (CSC)

FDA Devices Moderate Aug 14, 2019

Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of…

Randox Laboratories, Limited

FDA Devices Critical Aug 14, 2019

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

St Jude Medical Inc.

FDA Devices Moderate Aug 14, 2019

STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of the vagina to facilitate exami…

Centurion Medical Products Corporation

FDA Devices Moderate Aug 14, 2019

Brilliance 64 Model # 728231, computed tomography x-ray system

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Aug 14, 2019

CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to …

Biomet 3i, LLC

FDA Devices Moderate Aug 14, 2019

HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC …

Hycor Biomedical Inc

FDA Devices Moderate Aug 14, 2019

Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care System. The system is an oral care convenience ki…

Sage Products Inc

FDA Devices Moderate Aug 14, 2019

Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 1-2mm 0.5g, For single use only, Part Number 20126 - Product Usage: Augmentation…

Geistlich Pharma North America, Inc.

FDA Devices Moderate Aug 14, 2019

MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 …

MED-EL Elektromedizinische Gereate, Gmbh

FDA Devices Moderate Aug 14, 2019

Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 …

Philips North America, LLC

FDA Devices Moderate Aug 14, 2019

iCT, Model # 728306, computed tomography x-ray system

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Aug 14, 2019

VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentra…

Ortho-Clinical Diagnostics

FDA Devices Moderate Aug 14, 2019

VITROS 250 Chemistry System, clinical chemistry analyzer

Ortho Clinical Diagnostics

FDA Devices Critical Aug 14, 2019

ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)

St Jude Medical Inc.

FDA Devices Moderate Aug 14, 2019

YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control

Comet Technologies Usa Inc

FDA Devices Moderate Aug 14, 2019

SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive monitoring of c…

SenTec AG

FDA Devices Critical Aug 14, 2019

ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585

St Jude Medical Inc.

FDA Devices Moderate Aug 14, 2019

YXLON Cheetah cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control

Comet Technologies Usa Inc

FDA Devices Moderate Aug 14, 2019

14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for introducing a hemodialys…

Medical Components, Inc dba MedComp

FDA Devices Moderate Aug 14, 2019

LACERATION TRAY Kit Code: SUT18370 - Product Usage: Kit is used for laceration repairs for general population.

Centurion Medical Products Corporation

FDA Devices Moderate Aug 14, 2019

SNAG FREE SUTURE TRAY Kit Code: SUT14355 - Product Usage: Kit is used for laceration repairs for general population.

Centurion Medical Products Corporation

FDA Devices Moderate Aug 14, 2019

EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7G - REF ECP017G.Product U…

Bard Peripheral Vascular Inc

FDA Devices Moderate Aug 14, 2019

Ingenuity CT, Model # 728326, computed tomography x-ray system

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Aug 14, 2019

UNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit is used for regional anesthesia nerve blocks for general population.

Centurion Medical Products Corporation

FDA Devices Moderate Aug 14, 2019

Lantis Commander, Model # 4503178 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient usin…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Aug 14, 2019

LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silic…

Ad-Tech Medical Instrument Corporation

FDA Devices Low Aug 14, 2019

PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel test strips measure tot…

Polymer Technology Systems, Inc.

FDA Devices Moderate Aug 14, 2019

DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient popula…

Centurion Medical Products Corporation

FDA Devices Low Aug 14, 2019

Assayed Bovine Multi-Sera Level 1, Model No. AL1027

Randox Laboratories, Limited

FDA Devices Moderate Aug 14, 2019

The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled…

Abbott Gmbh & Co. KG

FDA Devices Moderate Aug 14, 2019

Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 20115 - Product Usage: Augment…

Geistlich Pharma North America, Inc.

FDA Devices Moderate Aug 14, 2019

CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessor…

Biomet 3i, LLC

FDA Devices Moderate Aug 14, 2019

VITROS 250 Chemistry System, clinical chemistry analyzer

Ortho Clinical Diagnostics

FDA Devices Moderate Aug 14, 2019

VITROS 5,1 FS Chemistry System, clinical chemistry analyzer

Ortho Clinical Diagnostics

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

Burstberry Laser Projection Series

Gk Photonics Inc

FDA Devices Moderate Aug 14, 2019

SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxyg…

SenTec AG

FDA Devices Moderate Aug 14, 2019

Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Aug 14, 2019

Lidar System for Erosion Flume Application Class 1 Laser Product Product Usage: Product is installed and fixed above a dynamic indoor flume desi…

ASTRA, LLC

FDA Devices Low Aug 14, 2019

Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS Panels Lipid Panel test strips…

Polymer Technology Systems, 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 7GV Upright (Vertical) - R…

Bard Peripheral Vascular Inc

FDA Devices Moderate Aug 14, 2019

Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tu…

ROi Consolidated Service Center (CSC)

FDA Devices Moderate Aug 14, 2019

VITROS 5,1 FS Chemistry System, clinical chemistry analyzer

Ortho Clinical Diagnostics

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