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 10 critical, 39 moderate, and 1 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 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

Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113

Straumann Manufacturing, Inc.

FDA Devices Moderate May 16, 2018

POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362

Bard Peripheral Vascular Inc

FDA Devices Moderate May 16, 2018

BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966

Datascope Corporation

FDA Devices Moderate May 16, 2018

PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.

Vygon U.S.A.

FDA Devices Moderate May 16, 2018

Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.

Vygon U.S.A.

FDA Devices Moderate May 16, 2018

Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

Cook Inc.

FDA Devices Moderate May 16, 2018

BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01

Datascope Corporation

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, 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

ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

BEQ-TOP 22701, Catalog No. 701050790

Datascope Corporation

FDA Devices Moderate May 16, 2018

Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.

Boston Scientific Corporation

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief 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

BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368

Datascope Corporation

FDA Devices Moderate May 16, 2018

Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE 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 Moderate May 16, 2018

BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434

Datascope Corporation

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, 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

BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and 35.5 keV gamma. The titanium wall of the BrachySource¿ Seed Implants absorbs the electrons.

Bard Brachytherapy, Inc.

FDA Devices Moderate May 16, 2018

BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01

Datascope Corporation

FDA Devices Moderate May 16, 2018

Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Replacement kit for outer shell, Broselow 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

Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-3050, 800-3079, 800-3080, 800-7190, 800-7713, 800-7714, 800-7715, 700- 7176-001, 700-7177-001 Product Usage: The iChemVELOCITY automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well a

Beckman Coulter Inc.

FDA Devices Moderate May 16, 2018

POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00005

Bard Peripheral Vascular Inc

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, 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

NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01

Datascope Corporation

FDA Devices Moderate May 16, 2018

MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.

Diagnostic Hybrids, Inc.

FDA Devices Moderate May 16, 2018

Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630

Synthes (USA) Products LLC

FDA Devices Critical May 16, 2018

Fabius GS Premium, anesthesia machine, catalog no. 8607000 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 concentratio

Draeger Medical, Inc.

FDA Devices Moderate May 16, 2018

Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX 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 ir

Baxter Healthcare Corporation

FDA Devices Moderate May 16, 2018

Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486

Datascope Corporation

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-relief 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, manometer, 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

AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated

Tornier, Inc

FDA Devices Moderate May 16, 2018

Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optio

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 16, 2018

BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867

Datascope Corporation

FDA Devices Moderate May 16, 2018

Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

Cook Inc.

FDA Devices Low May 16, 2018

Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

Michigan Instruments, Inc.

FDA Devices Moderate May 16, 2018

Jasper Vektor, Class II Correction Appliance, Part No. 610-533Lused 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

BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253

Datascope Corporation

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow 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

Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.

Vygon U.S.A.

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector 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

BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430

Datascope Corporation

FDA Devices Moderate May 16, 2018

Syngo.Via VB20A model 1049610

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 16, 2018

Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.

Ondamed Inc

FDA Devices Moderate May 16, 2018

POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362

Bard Peripheral Vascular Inc

FDA Devices Moderate May 16, 2018

BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461

Datascope Corporation

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.