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 29 distinct recalling firms operating in 5 distinct product categories, with 44 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (38), NHTSA (6), CPSC (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 Mar 14, 2018

LASEREDGE Knives, 1.6MM X 1.8MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7600, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

Philips Network Firewall (Cisco ASA 5506), Model # 867098

Philips Electronics North America Corporation

FDA Devices Moderate Mar 14, 2018

Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134302, Sterile, Rx. The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. They are designed to obtain electrograms in the atrial regions of the heart. The Reprocessed 2515 NAV eco Variable EP Catheters provide location informatio

Stryker Sustainability Solutions

FDA Devices Low Mar 14, 2018

Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.

Degania Silicone, Ltd.

FDA Devices Moderate Mar 14, 2018

VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic

Ortho-Clinical Diagnostics

FDA Devices Moderate Mar 14, 2018

A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The A-Series is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used for adult, pediatric, and infant populations.

Mindray DS USA, Inc. dba Mindray North America

FDA Devices Moderate Mar 14, 2018

INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM

Toshiba American Medical Systems Inc

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 15 DEGREE STAB BLADE TIP (6/BOX), REF/PRODUCT CODE E7515T, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 5.2MM IMPLANT BLADE ANGLED (6/BOX), REF/PRODUCT CODE E7561A, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)

Abbott Point Of Care Inc.

FDA Devices Moderate Mar 14, 2018

BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer module designed to control patient blood temperature during cardiopulmonary bypass procedures when heating or cooling of the blood is desired.

Medtronic Perfusion Systems

FDA Devices Moderate Mar 14, 2018

Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within the Logical Acetabular Cups. Product Usage: Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a

Signature Orthopedics Pty Limited

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 22.5 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7522, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED GUARDED (6/BOX), REF/PRODUCT CODE E7556AG, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry system. There are 15 segments with each cuvette segment holding 11 cuvette pairs (22 cuvettes) for a total of 165 cuvettes pairs or a total of 330 cuvettes (22 cuvettes x 15 cuvette segments) per reaction carousel. The firm name on the label is Abbott Laboratories, Abbott Park, IL. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests utilizi

Abbott Laboratories, Inc

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 2.65 MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7551A, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED GUARDED (6/BOX), REF/PRODUCT CODE E7601G, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic

Ortho-Clinical Diagnostics

FDA Devices Moderate Mar 14, 2018

2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

Synthes (USA) Products LLC

FDA Devices Moderate Mar 14, 2018

Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, e.g. low anterior resection. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of p

Covidien LLC

FDA Devices Moderate Mar 14, 2018

ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.

Stryker Corporation

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 3.2MM STRAIGHT SLIT KNIFE (6/BOX), REF/PRODUCT CODE E7557, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 2.2 MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7548ADB, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 1.8mm x 2.2mm TRAPEZOID ANGLED KNIFE (6/BOX), REF/PRODUCT CODE E7603G, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

O-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighting 60 lbs or greater and having an abdominal thickness of greater than 16cm, and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm O2 Im

Medtronic Navigation, Inc.-Littleton

FDA Devices Moderate Mar 14, 2018

3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

Synthes (USA) Products LLC

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, CRESCENT KNIFE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE E7510G, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Strykeflow 2 with Tip (Model 0250070520) STRYKER LAPAROSCOPIC SUCTION IRRIGATOR

Stryker Corporation

FDA Devices Moderate Mar 14, 2018

Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Mar 14, 2018

2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

Synthes (USA) Products LLC

FDA Devices Moderate Mar 14, 2018

cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module

Roche Diagnostics Corporation

FDA Devices Moderate Mar 14, 2018

VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic

Ortho-Clinical Diagnostics

FDA Devices Moderate Mar 14, 2018

2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 351.707S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

Synthes (USA) Products LLC

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 19 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7519, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 2.75MM THIN SLIT ANGLED BEVELED UP (6/BOX)(6/BOX), REF/PRODUCT CODE E7759A, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should b

Euro Diagnostica AB

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75PAR (6/BOX), REF/PRODUCT CODE E7575, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, CRESCENT BLADE STRAIGHT BEVEL UP STR (6/BOX), REF/PRODUCT CODE E7500, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

Bausch & Lomb Inc Irb

CPSC No agency class Mar 14, 2018

Cameron Company Recalls Children's Tents Due to Laceration Hazard; Sold Exclusively at Home Depot

Jinhua Longyou Import and Export Co., of China

CPSC No agency class Mar 14, 2018

Radio Flyer Recalls Electric Wagons Due to Injury Hazard

NHTSA No agency class Mar 14, 2018

MASERATI 2017: ENGINE AND ENGINE COOLING:ENGINE

MASERATI

CPSC No agency class Mar 13, 2018

Amazon Recalls Portable Power Banks Due to Fire and Chemical Burn Hazards (Recall Alert)

Guoguang Electric Company Limited, of China

CPSC No agency class Mar 13, 2018

Helvetia Sports Recalls SwissStop Bicycle Disc Brake Pads Due to Fall Hazard

Helvetia Sports, of Peterborough, ON, Canada

CPSC No agency class Mar 13, 2018

MAAX Spas Recalls Hot Tubs and Swim Spas Due to Fire Hazard

MAAX Spas Industries Corp., Chandler, Arizona

NHTSA No agency class Mar 13, 2018

HONDA 2014-2016: SEATS:MID/REAR ASSEMBLY

HONDA

NHTSA No agency class Mar 12, 2018

FORD 2013-2016: POWER TRAIN:MANUAL TRANSMISSION

FORD

NHTSA No agency class Mar 12, 2018

FORD,LINCOLN 2014-2018: STEERING: STEERING WHEEL/HANDLE BAR

FORD,LINCOLN

NHTSA No agency class Mar 12, 2018

HYUNDAI 2016-2017: HYBRID PROPULSION SYSTEM

HYUNDAI

NHTSA No agency class Mar 9, 2018

FERRARI 2016: SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS:DISC

FERRARI

USDA FSIS Moderate Mar 9, 2018

Heartland Catfish Company Recalls Siluriformes Fish Products Due to Possible Adulteration

Heartland Catfish Company, LLC

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.