PlainRecalls

2018 Recalls

6,355 recalls · Page 26 of 128

2018 Recall Year Insight

Federal agencies issued 6,355 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.57% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 17.4 recalls per day across the FDA, CPSC, NHTSA, and USDA FSIS 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 128 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 16 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, NHTSA, or USDA FSIS 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

Affixus Hip Fracture Nail Right 125 11 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 Right 125 13 mm x 180 mm, Item Number 814313180 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 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 440 mm, Item Number 814409440 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 360 mm, Item Number 814411360 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Atellica IM 1600 Analyzer (SMN 11066000). 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 Right 125 9 mm x 320 mm, Item Number 814309320 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.

Cypress Medical Products LLC

FDA Devices Moderate Oct 24, 2018

Multirall(TM) 200Liko Strap Gripper P/N 3136250 overhead lift for patient transfer situations.

Liko AB

FDA Devices Moderate Oct 24, 2018

Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical …

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Oct 24, 2018

Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number 814309360 Product Usage: Intended for the fixation of fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 24, 2018

Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188

Terumo Cardiovascular Systems Corporation

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…

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…

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: …

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 speci…

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 temperatu…

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 singl…

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…

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-…

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 …

OriGen Biomedical, 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: CPSC + NHTSA + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2018