PlainRecalls

2018 Recall Year Insight

Federal agencies issued 7,928 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.59% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 21.7 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 159 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 2018.

On this page of 50 records, severity classification shows 8 critical, 42 moderate, and 0 lower-severity recalls. The page references 15 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 2018 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 May 16, 2018

BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295

Datascope Corporation

FDA Devices Moderate May 16, 2018

ADVIA Centaur¿ HBc IgM

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.

Randox Laboratories Ltd.

FDA Devices Moderate May 16, 2018

Jasper Vektor, Class II Correction Appliance, Part No. 610-536L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

TP Orthodontics, Inc.

FDA Devices Moderate May 16, 2018

Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system.

Vygon U.S.A.

FDA Devices Moderate May 16, 2018

BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899

Datascope Corporation

FDA Devices Moderate May 16, 2018

EasyTouch (ET) Insulin Syringe 29G 1ml ¿" (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY

MHC Medical Products LLC

FDA Devices Moderate May 16, 2018

EasyTouch (ET) Insulin Syringe 29G 0.5ml ¿" (Item 829555) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY

MHC Medical Products LLC

FDA Devices Moderate May 16, 2018

POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301

Bard Peripheral Vascular Inc

FDA Devices Moderate May 16, 2018

Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

IMMULITE ¿ /IMMULITE ¿ 1000 CEA

Siemens Healthcare Diagnostics, Inc.

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Adult, with mask, 28inch large bore tubing Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Vyaire Medical

FDA Devices Moderate May 16, 2018

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or i

Baxter Healthcare Corporation

FDA Devices Moderate May 16, 2018

Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system.

Vygon U.S.A.

FDA Devices Moderate May 16, 2018

Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02

Datascope Corporation

FDA Devices Moderate May 16, 2018

Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/10445148) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

Jasper Vektor, Class II Correction Appliance, Part No. 610-533 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

TP Orthodontics, Inc.

FDA Devices Moderate May 16, 2018

Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6975207, 7mm Product Usage: The PRESTIGE LP reusable instruments are intended for the surgical implantation of the PRESTIGE LP Cervical Disc. Medtronic reusable instruments must be sterilized prior to initial use and must be cleaned and sterilized prior to each re-use.

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate May 16, 2018

Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W

Straumann Manufacturing, Inc.

FDA Devices Moderate May 16, 2018

PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.

Vygon U.S.A.

FDA Devices Moderate May 16, 2018

Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge

Siemens Healthcare Diagnostics, Inc.

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, filter Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Vyaire Medical

FDA Devices Critical May 16, 2018

Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO

Draeger Medical, Inc.

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Vyaire Medical

FDA Devices Moderate May 16, 2018

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300

Bard Peripheral Vascular Inc

FDA Devices Moderate May 16, 2018

POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300

Bard Peripheral Vascular Inc

FDA Devices Moderate May 16, 2018

FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System

Inpeco S.A.

FDA Devices Moderate May 16, 2018

Jasper Vektor, Class II Correction Appliance, Part No. 610-530 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

TP Orthodontics, Inc.

FDA Devices Moderate May 16, 2018

ADVIA Centaur¿ Cyclosporine

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to the orthopedic surgeon with a means of bone fixation and to assist in the management of reconstructive surgeries.

DePuy Mitek, Inc., a Johnson & Johnson Co.

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Vyaire Medical

FDA Devices Moderate May 16, 2018

Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or

Baxter Healthcare Corporation

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Vyaire Medical

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Vyaire Medical

FDA Devices Moderate May 16, 2018

POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301

Bard Peripheral Vascular Inc

FDA Devices Moderate May 16, 2018

IMMULITE ¿ /IMMULITE ¿ 1000 Vitamin B12

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate May 16, 2018

Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Infant, with mask, 40 inch oxygen reservoir tubing, pressure-relief valve, CO2 detector, manometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Vyaire Medical

FDA Devices Moderate May 16, 2018

Jasper Vektor, Class II Correction Appliance, Part No. 610-527L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

TP Orthodontics, Inc.

FDA Devices Moderate May 16, 2018

PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.

Boston Scientific Corporation

FDA Devices Moderate May 16, 2018

Jasper Vektor, Class II Correction Appliance, Part No. 610-530R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

TP Orthodontics, Inc.

FDA Devices Moderate May 16, 2018

Uphold Vaginal Support System; Model #M0068317080. Indicated for tissue reinforcement in women with pelvic organ prolapse.

Boston Scientific Corporation

FDA Devices Moderate May 16, 2018

Jasper Vektor, Class II Correction Appliance, Part No. 610-533R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

TP Orthodontics, Inc.

FDA Devices Moderate May 16, 2018

POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004

Bard Peripheral Vascular Inc

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2018 with 2017 →

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 2018

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 2018 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.