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 0 critical, 50 moderate, and 0 lower-severity recalls. The page references 18 distinct recalling firms operating in 1 distinct product categories, with 37 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 Jul 25, 2018

ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S & 181023S

NewDeal SA

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631

Ethicon, Inc.

FDA Devices Moderate Jul 25, 2018

Presource PBDS, Kit, Common. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative compli

Cardinal Health 200, LLC

FDA Devices Moderate Jul 25, 2018

Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item Code EGIA454AVM

COVIDIEN MEDTRONIC

FDA Devices Moderate Jul 25, 2018

Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system , Item Code EGIA30CTAV

COVIDIEN MEDTRONIC

FDA Devices Moderate Jul 25, 2018

MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, packaged 10/case, Sterile, RX. The firm name on the label is chs, Oakville, ON, Canada.

Canadian Hospital Specialties

FDA Devices Moderate Jul 25, 2018

Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Vascular/Medium, Item Code SIG30AVM

COVIDIEN MEDTRONIC

FDA Devices Moderate Jul 25, 2018

t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B.

Tandem Diabetes Care Inc

FDA Devices Moderate Jul 25, 2018

Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Double Spike, Ref ASU1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

Cardinal Health 200, LLC

FDA Devices Moderate Jul 25, 2018

Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike, Ref ASU1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

Cardinal Health 200, LLC

FDA Devices Moderate Jul 25, 2018

Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-opera

Cardinal Health 200, LLC

FDA Devices Moderate Jul 25, 2018

PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027

Ethicon, Inc.

FDA Devices Moderate Jul 25, 2018

AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25, Catalog Number: CS012 Control slides included as a component of the QFFIXBC1-25. The slides will provide non-fluorescent, wettable surface with dimensions appropriate for testing samples with QuickFISH BC culture identification kits.

Opgen Inc

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067

Ethicon, Inc.

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292

Ethicon, Inc.

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881

Ethicon, Inc.

FDA Devices Moderate Jul 25, 2018

Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, Item Code EGIA60AMT

COVIDIEN MEDTRONIC

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995

Ethicon, Inc.

FDA Devices Moderate Jul 25, 2018

Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

Fx Solutions

FDA Devices Moderate Jul 25, 2018

Hydroline Trumpet Valve, Trumpet Valve, No Probe, Double Spike, Ref ASU1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

Cardinal Health 200, LLC

FDA Devices Moderate Jul 25, 2018

Endo GIA 60 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item Code EGIA60AVM

COVIDIEN MEDTRONIC

FDA Devices Moderate Jul 25, 2018

Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home.Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) fro

Intel-GE Care Innovations LLC

FDA Devices Moderate Jul 25, 2018

RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A) Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer

RAYSEARCH LABORATORIES AB

FDA Devices Moderate Jul 25, 2018

Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Jul 25, 2018

Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA60AXT

COVIDIEN MEDTRONIC

FDA Devices Moderate Jul 25, 2018

Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA45AXT

COVIDIEN MEDTRONIC

FDA Devices Moderate Jul 25, 2018

Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S, 111770S, 111775S, 111780S, 111785S, 111790S, 111795S, 111800S, 111805S, 111810S, 111815S, 111820S, 121740S, 121745S, 121750S, 121755S, 121760S, 121765S, 121770S, 121775S, 121780S, 121785S, 121790S, 121795S, 121800S, 121805S, 121810S, 121815S & 121820S

NewDeal SA

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768

Ethicon, Inc.

FDA Devices Moderate Jul 25, 2018

Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Jul 25, 2018

AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150 The Cardica C-Port Flex-A PLUS Distal Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel and conduit. The stainless steel clips create a complete end-to-side anastomosis that is functionally equivalent to a hand-sutured interrupted stitch anastomosis. The system consists of one Anastomosis Device and one Retractor Mount. The system is designed with

AESDEX

FDA Devices Moderate Jul 25, 2018

Hydroline Trumpet Valve with Pulse Wave Cassette, Cassette Trumpet Valve with Bariatric Probe, Double Spike, Ref ABP1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

Cardinal Health 200, LLC

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988

Ethicon, Inc.

FDA Devices Moderate Jul 25, 2018

Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operati

Cardinal Health 200, LLC

FDA Devices Moderate Jul 25, 2018

AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The Cardica C-Port xA PLUS Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel (e.g. coronary artery) and conduit (e.g. saphenous vein graft). The stainless steel clips create a complete end-to-side anastomosis that is functionally equivalent to a hand-sutured interrupted stitch anastomosis. The system consists of one Anastomosis Device and one Retractor Moun

AESDEX

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416

Ethicon, Inc.

FDA Devices Moderate Jul 25, 2018

Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope

Zeiss, Carl Inc

FDA Devices Moderate Jul 25, 2018

ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004S

NewDeal SA

FDA Devices Moderate Jul 25, 2018

T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Specifically the T210 Treadmill is intended for use in Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.

GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

FDA Devices Moderate Jul 25, 2018

Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 45 mm Vascular/Medium, Item Code SIG45ACTAVM

COVIDIEN MEDTRONIC

FDA Devices Moderate Jul 25, 2018

MX-10 surveillance laser system Product Usage: The expected usage of the product is to facilitate observation and surveillance missions from safe standoff ranges.

Wescam Inc

FDA Devices Moderate Jul 25, 2018

Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

Ion Beam Applications S.A.

FDA Devices Moderate Jul 25, 2018

Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Jul 25, 2018

Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Medium/Thick, Item Code SIG30AMT

COVIDIEN MEDTRONIC

FDA Devices Moderate Jul 25, 2018

Presource PBDS, Kit, No Spiro. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative comp

Cardinal Health 200, LLC

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844

Ethicon, Inc.

FDA Devices Moderate Jul 25, 2018

Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMONIC ACE¿+7, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic struc

Stryker Sustainability Solutions

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688

Ethicon, Inc.

FDA Devices Moderate Jul 25, 2018

Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intended for: Shoulder - Rotator Cuff Repair - Bankart Repair - SLAP Lesion Repair - Biceps Tenodesis - Acromio-Clavicular Separation Repair - Deltoid Repair - Capisular Shift or Capsulolabral Reconstruction Foot/Ankle - Lateral Stabilization - Medial Stabilization - Achilles Tendon Repair Knee - Medial Collateral Ligament Repair - Lateral Collateral Ligament Repair - Posterior Oblique Ligament Repair - Illiotibial

Valeris Medical, LLC

FDA Devices Moderate Jul 25, 2018

Endo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with Tri-Staple Technology, Item Code EGIA45CTAVM

COVIDIEN MEDTRONIC

FDA Devices Moderate Jul 25, 2018

PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662

Ethicon, 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.