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 6 critical, 43 moderate, and 1 lower-severity recalls. The page references 24 distinct recalling firms operating in 6 distinct product categories, with 43 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (36), CPSC (8), NHTSA (5), 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 Oct 3, 2018

Allura Xper F010 DR Table, System Code 722014 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper.

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally invasive surgery. All three components must be powered on for the system to be functional.

Intuitive Surgical, Inc.

FDA Devices Moderate Oct 3, 2018

Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide-Field Elite Pack, REF SE5523WV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack, REF SE5420M (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, 6 trays/shipper.

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide-Field Elite Pack, REF SE5525WV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-Field Elite Pack, REF SE5525MV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

ESSENTIO Pacemaker

Boston Scientific Corporation

FDA Devices Low Oct 3, 2018

Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35

Medtronic Vascular

FDA Devices Moderate Oct 3, 2018

Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Oct 3, 2018

ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging

Swissray Medical

FDA Devices Moderate Oct 3, 2018

Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Knee, Hand and Wrist and Hip repair.Stainless Steel, Sterile Item Number: 110016992

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid-Field Elite Pack, REF SE5425MV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542

Medtronic Navigation, Inc.

FDA Devices Moderate Oct 3, 2018

HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-135-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures

Biomet UK Ltd.

FDA Devices Moderate Oct 3, 2018

Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: Compound and simple shaft fractures Proximal, metaphyseal and distal shaft fractures Segmental fractures Comminuted fractures Fractures involving osteopenic and osteoporotic bone Pathological fractures Fractures with bo

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-Field Elite Pack, REF SE5523MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

INTEGRIS Allura 15-12 (biplane), System Code 722044 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

INTEGRIS Allura 9 F FDXD, System Code 722497 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Oct 3, 2018

AIIuraXperFDlO, System Code 722010 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.

Boston Scientific Corporation

FDA Devices Moderate Oct 3, 2018

VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)

Boston Scientific Corporation

FDA Devices Moderate Oct 3, 2018

Allura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

Reckitt Benckiser LLC

FDA Devices Moderate Oct 3, 2018

Allura Xper F010, System Code 722003 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Shockwave S4, Peripheral Intravascular Lithotripsy Catheter, CE 0086, STERILE R, Manufacturer: Shockwave Medical, Inc. 48501 Warm Springs Blvd. Ste. 108, Fremont, CA 94539

Shockwave Medical, Inc.

FDA Devices Moderate Oct 3, 2018

Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gun Magazine. REF CM8902, Medtronic Clip Gun Magazine, Rx only, CE 0344, STERILE EO, Rx only, Single Use

Medtronic Neurosurgery

CPSC No agency class Oct 3, 2018

Walmart Recalls Camp Axes Due to Injury Hazard

Gardex, of India

CPSC No agency class Oct 3, 2018

Yamaha Recalls Golf Cars, Personal Transportation and Specialty Vehicles Due to Crash Hazard (Recall Alert)

Yamaha Motor Manufacturing Corporation of America, of Newnan, Ga.

USDA FSIS Critical Oct 3, 2018

Johnston County Hams Recalls Ready-To-Eat Ham Products Due to Possible Listeria Contamination

CPSC No agency class Oct 2, 2018

AAA Innovations Recalls Promotional Cooler/Grills Due to Fire Hazard

CPSC No agency class Oct 1, 2018

UberScientific Recalls Topical Anesthetic Due to Failure to Meet Child Resistant Closure Requirement; Risk of Poisoning

UberScientific LLC, of Kissimmee, Fla.

NHTSA No agency class Oct 1, 2018

MERCEDES-BENZ 2016-2018: STRUCTURE:BODY:ROOF AND PILLARS

MERCEDES-BENZ

CPSC No agency class Sep 28, 2018

Boy Story Recalls Action Dolls Due to Choking Hazard

Mentor International Corp. of Dongguan City, Guangdong Province, China

NHTSA No agency class Sep 28, 2018

BMW 2019: SUSPENSION:REAR

BMW

NHTSA No agency class Sep 28, 2018

JEEP 2018-2019: STRUCTURE:FRAME AND MEMBERS

JEEP

CPSC No agency class Sep 27, 2018

IKEA Recalls Ceiling Lamps Due to Impact and Laceration Hazards

IKEA Supply AG, of Switzerland

CPSC No agency class Sep 27, 2018

Life Fitness Recalls PowerMill Climber Due to Fire Hazard

Life Fitness, of Rosemont, Ill.

CPSC No agency class Sep 27, 2018

TerraTrike Recalls Adult Tricycles Due to Crash Hazard

Forever Machine Industrial Co., Ltd., of Taichung, Taiwan

NHTSA No agency class Sep 27, 2018

HONDA 2019: SEAT BELTS:PRETENSIONER

HONDA

NHTSA No agency class Sep 27, 2018

HONDA 2017-2018: STEERING:ELECTRIC POWER ASSIST SYSTEM

HONDA

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.