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 7 critical, 43 moderate, and 0 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 Critical May 16, 2018

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

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.

Boston Scientific Corporation

FDA Devices Critical May 16, 2018

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

Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abrasions

Integra LifeSciences Corp.

FDA Devices Moderate May 16, 2018

Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623

Synthes (USA) Products LLC

FDA Devices Moderate May 16, 2018

Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099

Straumann Manufacturing, Inc.

FDA Devices Moderate May 16, 2018

IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179

Datascope Corporation

FDA Devices Moderate May 16, 2018

BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504

Datascope Corporation

FDA Devices Moderate May 16, 2018

Jasper Vektor, Class II Correction Appliance, Part No. 610-527R 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 Critical May 16, 2018

AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, 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 Critical May 16, 2018

Fabius MRI, anesthesia machine, catalog no. 8607300 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 (FiO2

Draeger Medical, Inc.

FDA Devices Moderate May 16, 2018

ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee

DePuy Orthopaedics, Inc.

FDA Devices Moderate May 16, 2018

IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.

Boston Scientific Corporation

FDA Devices Moderate May 16, 2018

BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622

Datascope Corporation

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Infant, 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

POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362

Bard Peripheral Vascular Inc

FDA Devices Moderate May 16, 2018

BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513

Datascope Corporation

FDA Devices Moderate May 16, 2018

ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. (Product Numbers: 10318168, 10309500), ALT P5P (Part Numbers: 10318168/10326245, 10309500/10315181), and ALT Concentrated (Part Numbers: 10283341, 10283341, 10283342); (Mfr: Randox Laboratories)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300

Bard Peripheral Vascular Inc

FDA Devices Moderate May 16, 2018

ADVIA Centaur¿ DHEA-SO4

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.

Zimmer Biomet, Inc.

FDA Devices Moderate May 16, 2018

POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301

Bard Peripheral Vascular Inc

FDA Devices Moderate May 16, 2018

Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR 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

Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W

Straumann Manufacturing, Inc.

FDA Devices Moderate May 16, 2018

POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300

Bard Peripheral Vascular Inc

FDA Devices Moderate May 16, 2018

Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment.

Transonic Systems Inc

FDA Devices Moderate May 16, 2018

Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549

Beaver-Visitec International Inc.

FDA Devices Moderate May 16, 2018

Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS 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

Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 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

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 16, 2018

RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.

Mako Surgical Corporation

FDA Devices Moderate May 16, 2018

Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-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

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

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

Boston Scientific Corporation

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Adult, 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 Moderate May 16, 2018

BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog No. 701053845

Datascope Corporation

FDA Devices Moderate May 16, 2018

ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product Number: 10286035 (Mfr: Randox Laboratories)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee

DePuy Orthopaedics, Inc.

FDA Devices Moderate May 16, 2018

Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504

Datascope Corporation

FDA Devices Moderate May 16, 2018

Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874

Datascope Corporation

FDA Devices Moderate May 16, 2018

ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810

Hyphen BioMed

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor 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

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

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.