PlainRecalls

2018 Recalls

Compiled from official public sources by the editorial team.

7,717 recalls · Page 125 of 155

2018 Recall Year Insight

Federal agencies issued 7,717 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.70% of the 100,165 total recalls we track from 1995 through the present, and averages roughly 21.1 recalls per day across the FDA, CPSC, 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 155 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, 49 moderate, and 1 lower-severity recalls. The page references 24 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, 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, CLEAR CORNEAL ANGLED 2.75 (6/BOX), REF/PRODUCT CODE E7527, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended f…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, KNIFE ANGLED BEVELED UP 2.7(6/BOX), REF/PRODUCT CODE E7559A, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.85 (6/BOX), REF/PRODUCT CODE E7528, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended f…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.9MM (6/BOX), REF/PRODUCT CODE E7587A, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 0.88MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7593, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended f…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

Synthes (USA) Products LLC

FDA Devices Moderate Mar 14, 2018

Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

Synthes (USA) Products LLC

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 30 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7530, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for op…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED BEVEL UP GUARDED (6/BOX), REF/PRODUCT CODE E7551AG, STERILE, Rx Only Product Usage: The LaserEdge Kni…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

INFX-8000H Fluoroscopic X-Ray Systems

Toshiba American Medical Systems Inc

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 4.0MM IMPLANT BLADE ANGLED (6/BOX), REF/PRODUCT CODE E7560A, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended f…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryk…

Stryker Corporation

FDA Devices Moderate Mar 14, 2018

Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400

Instrumentation Laboratory Co.

FDA Devices Moderate Mar 14, 2018

The GC80 Digital X-ray Imaging System

NeuroLogica Corporation

FDA Devices Moderate Mar 14, 2018

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3…

Roche Diagnostics Corporation

FDA Devices Moderate Mar 14, 2018

Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 75.80.04

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 14, 2018

Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.

Wiener Laboratories

FDA Devices Moderate Mar 14, 2018

Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.

DePuy Orthopaedics, Inc.

FDA Devices Moderate Mar 14, 2018

ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are 9 segments with each cuvett…

Abbott Laboratories, Inc

FDA Devices Moderate Mar 14, 2018

Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Sterile, Rx. The Reprocessed 2…

Stryker Sustainability Solutions

FDA Devices Moderate Mar 14, 2018

2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

Synthes (USA) Products LLC

FDA Devices Moderate Mar 14, 2018

QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be use…

Z-Medica, LLC

FDA Devices Moderate Mar 14, 2018

Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 Product Usage: Computed Tomography X-ray systems intended to produce…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Mar 14, 2018

O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643…

Medtronic Navigation, Inc.-Littleton

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7556ADB, STERILE, Rx Only Product Usage: The LaserEdge Knives …

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

241-McKesson Premium Skin Staple Remover Kit, Item #100123, McKesson I.V. Start Kit, 100124-McKesson Suture Removal Kit, and 82-15 Cypress Medical Pr…

Cypress Medical Products LLC

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, CRESCENT BLADE BEVELED DN (6/BOX), REF/PRODUCT CODE E7510D, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended …

Bausch & Lomb Inc Irb

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 inten…

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 2…

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 Syst…

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 f…

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 f…

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 contro…

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%…

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 …

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 in…

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 cuv…

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 …

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 ar…

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…

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 f…

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…

Bausch & Lomb Inc Irb

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: CPSC + NHTSA — consumer product and vehicle recall feeds for 2018