PlainRecalls

2018 Recalls

Compiled from official public sources by the editorial team.

7,717 recalls · Page 134 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 9 critical, 39 moderate, and 2 lower-severity recalls. The page references 32 distinct recalling firms operating in 4 distinct product categories, with 48 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (35), FDA Food (9), CPSC (4), 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 Feb 28, 2018

Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6X…

Med Tec Inc

FDA Devices Moderate Feb 28, 2018

Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018

Arrow International Inc

FDA Devices Moderate Feb 28, 2018

Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Features; Product …

Arrow International Inc

FDA Devices Low Feb 28, 2018

Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559

Ivoclar Vivadent, Inc.

FDA Devices Moderate Feb 28, 2018

Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product Code: ASK 42703 PUHC; Exp. Dates Feb 2018 - Nov 2018

Arrow International Inc

FDA Devices Critical Feb 28, 2018

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. …

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate Feb 28, 2018

NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.

ZIMMER ORTHOPEDIC MFG LTD

FDA Devices Moderate Feb 28, 2018

ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet

Arrow International Inc

FDA Devices Moderate Feb 28, 2018

Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

Roche Diagnostics Corporation

FDA Devices Moderate Feb 28, 2018

ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammograp…

Fujifilm Medical Systems U.S.A., Inc.

FDA Devices Critical Feb 28, 2018

Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia AF MRI VR SureScan ICD DF1 (Product No. DVFB1D1); …

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate Feb 28, 2018

Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000…

Fujifilm Medical Systems U.S.A., Inc.

FDA Devices Moderate Feb 28, 2018

Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK 15703 NYP; Exp. Dates Feb 201…

Arrow International Inc

FDA Devices Moderate Feb 28, 2018

PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS…

Merit Medical Systems, Inc.

FDA Devices Moderate Feb 28, 2018

Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.

Allen Medical Systems

FDA Devices Moderate Feb 28, 2018

OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, M…

Oculus Optikgeraete GMBH

FDA Devices Moderate Feb 28, 2018

Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q

Hologic, Inc.

FDA Devices Moderate Feb 28, 2018

LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone …

Synthes, Inc.

FDA Devices Low Feb 28, 2018

Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503

Ivoclar Vivadent, Inc.

FDA Devices Moderate Feb 28, 2018

Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T The AFFINITY NT Cardiotomy/Venous Reser…

Medtronic Perfusion Systems

FDA Devices Moderate Feb 28, 2018

Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product code: ASK-45703-PHF2; Exp. Dates Feb 2018 - Nov 20…

Arrow International Inc

FDA Devices Moderate Feb 28, 2018

Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external de…

Philips Electronics North America Corporation

FDA Devices Critical Feb 28, 2018

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: a. Compia MRI CRT-D DF1 (Product No. DTMC1D1); …

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate Feb 28, 2018

Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software (model, MMT-7340) is intended to be us…

Medtronic Inc.

FDA Devices Moderate Feb 28, 2018

Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy

DeRoyal Industries Inc

FDA Devices Moderate Feb 28, 2018

Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty

Zimmer Biomet, Inc.

FDA Devices Moderate Feb 28, 2018

AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 2018 - Nov 2018

Arrow International Inc

FDA Devices Moderate Feb 28, 2018

Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)

Philips Consumer Lifestyle

FDA Devices Critical Feb 28, 2018

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); …

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Critical Feb 28, 2018

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria MRI CRT-D DF1 (Product No. DTMA1D1); …

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate Feb 28, 2018

Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit; Product Codes: ASK-45703-PNHS; ASK-45703-PGMCL; ASK-45703-P…

Arrow International Inc

FDA Devices Moderate Feb 28, 2018

Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Ex…

Boston Scientific Corporation

FDA Devices Moderate Feb 28, 2018

20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

FDA Devices Moderate Feb 28, 2018

Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that…

Fujifilm Medical Systems U.S.A., Inc.

FDA Devices Moderate Feb 28, 2018

Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection…

Covidien LLC

CPSC Moderate Feb 28, 2018

PL Sleep Children's Sleepwear Recalled by Lemur Group Due to Violation of Federal Flammability Standard

NHTSA Critical Feb 27, 2018

HYUNDAI 2011-2013: SEAT BELTS:PRETENSIONER

HYUNDAI

CPSC Moderate Feb 26, 2018

Allen Sports Recalls Folding Bicycles Due to Fall Hazard

CPSC Moderate Feb 22, 2018

Monster Moto Recalls Mini Bikes Due to Fire Hazard

Monster Moto LLC, of Ruston, La.

CPSC Moderate Feb 22, 2018

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

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

NHTSA Critical Feb 22, 2018

JEEP 2017: ENGINE AND ENGINE COOLING:ENGINE

JEEP

FDA Food Moderate Feb 21, 2018

Larabar Chocolate Chip Cookie Dough, 5 - 1.6 oz (45g) bars Net Wt 8.0 oz(226g), UPC 21908-48817. Case UPC 000-21908-41675-5

General Mills, Inc

FDA Food Moderate Feb 21, 2018

BROLITE PRODUCT #6109 BREAD FLAVOR R, Net Wt. 50 Lbs

Brolite Products Inc

FDA Food Moderate Feb 21, 2018

BROLITE PRODUCT #5015 SPONGE AND DOUGH, Net Wt. 50 Lbs

Brolite Products Inc

FDA Food Critical Feb 21, 2018

Arthri-D 120ct

ABH Nature's Products, Inc.

FDA Food Moderate Feb 21, 2018

WALNUT CREEK FOODS Caramel Popcorn NET WT 15 OZ (425g) Ingredients: Evaporated Can Juice, Popcorn, Butter (cream, salt), Salt, Sodium Bicarbonate, Cr…

Coblentz Distributing Inc dba Walnut Creek Foods

FDA Food Moderate Feb 21, 2018

STAR WARS TIN WITH CARAMEL POPCORN NET WT 3.5 oz (99g) CONTAINS MILK AND SOY, MAY CONTAIN TREE NUTS AND PEANUTS DISTRIBUTED BY GALERIE HEBRON, KENTUC…

Ross Acquisitions Company

FDA Food Critical Feb 21, 2018

Weis Weis Markets, Inc., Sunbury, PA 17801-0471; Keep Refrigerated; Dried Beef Party Rye Dip; Ingredients: Hellman's Mayonaise, Sour Cream, Dried Bee…

WEIS MARKETS

FDA Food Moderate Feb 21, 2018

#6600 TJ TORTILLA, Net Wt. 50 Lbs

Brolite Products Inc

FDA Food Moderate Feb 21, 2018

Live Better Drug Free Black Elderberry Syrup, 4 FL OZ (118 mL); DIETARY SUPPLEMENT, UPC 050428581186

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