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 15 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, 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 24, 2018

SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009

Baxter Healthcare Corporation

FDA Devices Moderate Oct 24, 2018

ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.

Siemens Healthcare Diagnostics, Inc

FDA Devices Moderate Oct 24, 2018

Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Number 10507786 c) Flow 20-4R, Material Number 10528958 d) m Flow 64-4R, Material Number 10529161 e) mCT S(40)-4R, Material Number 10248671 f) mCT S(64)-4R, Material Number 0248672 g) mCT S(20)-3R, Material Number 10534159 h) mCT Flow Edge-4R, Material Number 10528955 i) mCT Flow 40-3R, Material Number 10529158 j) mCT Flow 64-3R, Material Number 10529160 k) mCT X-4R, Material Number 10248670 l) mCT

Siemens Medical Solutions USA, Inc.

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number 814511180 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Right 130 13 mm x 360 mm, Item Number 814513360 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number 814409460 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Right 125 9 mm x 260 mm, Item Number 814309260 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.

Siemens Healthcare Diagnostics, Inc

FDA Devices Moderate Oct 24, 2018

Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use

Life Technologies, Corp.

FDA Devices Moderate Oct 24, 2018

CryoPatch SG Pulmonary Hemi-Artery, 1 graft

CryoLife, Inc.

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number 814511320 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01

Carl Zeiss Meditec AG

FDA Devices Moderate Oct 24, 2018

Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.

OriGen Biomedical, Inc.

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number 814311380 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number 814311360 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number 814311340 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00

Mindray DS USA, Inc. dba Mindray North America

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number 814309380 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number 814411320 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 Low temperature smooth interior tubing is a disposable pulmonary equipment interconnect used in ventilation and aesthesia machines.

A M Systems Inc

FDA Devices Moderate Oct 24, 2018

Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.

OriGen Biomedical, Inc.

FDA Devices Moderate Oct 24, 2018

Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Oct 24, 2018

Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.

Thoratec Switzerland GMBH

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number 814413340 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061

Life Technologies, Corp.

FDA Devices Moderate Oct 24, 2018

Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO

OriGen Biomedical, Inc.

FDA Devices Moderate Oct 24, 2018

Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Oct 24, 2018

GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T EXCITE GS, 1.5T EXCITE HYBRID, 1.5T EXCITE TWIN, 1.5T EXCITE UPGRAD, 1.5T HD ES/HS TR W/EXCITE, 1.5T MR MOBILE (SERIAL # R350), 1.5T SIGNA ECHOSPEED, 1.5T SIGNA EXCITE, 1.5T SIGNA EXCITE MRI, 1.5T SIGNA VIBRANT 16CH FIXED, 3.0T MRI TWINSPEED 8CH, 3.0T SIGNA EXCITE FIXED, 3.0T SIGNA EXCITE UPGRADE, 3T EXCITE, EX ES+8CH USED EXCITE, EXCITE 1.5T,

GE Medical Systems, LLC

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Right 125 13 mm x 440 mm, Item Number 814313440 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-AP, MR GOLDSEAL 1.5T HD 8CH USED, UPGRADE 1.5 EXC-II TO EXC-III HD, SIGNA MR/I HISPD W/ EXCITE, 1.5 ECHOSPEED HD 16-CH 800-AP, 1.5 HISPEED HD 4-CH 200-AP, 1.5 TWINSPEED HD 8CH-400-AP, MR UPGRADE LX/HZ TO HD FOR NON LCC, 1.5 TWINSPEED HD 16CH-800-AP, 1-5T HDXT TWINSPEED 16 CHANNEL, SIGNA MR/I TWISP TR W/EXCITE, 3T HD 16CH-800-AP, 1.5 ECHOSPEED HD 4

GE Medical Systems, LLC

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Left 130 11 mm x 400 mm, Item Number 814611400 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail 125 11mm x 180mm, Item Number 814311180 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.

OriGen Biomedical, Inc.

FDA Devices Moderate Oct 24, 2018

Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000

Besmed Health Business Corporation

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Right 125 13 mm x 280 mm, Item Number 814313280 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each package contains (1) PEEK Screw, (1) #2 ForceBraid Blue, and (1) #2 ForceBraid White, 5 packages per container, Sterile, Rx. The firm name on the label is Valeris Medical, Marietta, GA.

Valeris Medical, LLC

FDA Devices Moderate Oct 24, 2018

Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use SKU 14040141

Life Technologies, Corp.

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Left 130 11 mm x 380 mm, Item Number 814611380 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use

Life Technologies, Corp.

FDA Devices Moderate Oct 24, 2018

Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.

OriGen Biomedical, Inc.

FDA Devices Moderate Oct 24, 2018

ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.

Siemens Healthcare Diagnostics, Inc

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail - Left 125 11mm x 340mm, Item Number 814411340 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Right 125 13 mm x 260 mm, Item Number 814313260 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Left 125 11 mm x 260 mm, Item Number 814411260 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, 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.