PlainRecalls

2018 Recalls

6,355 recalls · Page 43 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 2 critical, 45 moderate, and 3 lower-severity recalls. The page references 20 distinct recalling firms operating in 1 distinct product categories, with 32 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 Aug 29, 2018

DigitalDiagnost Dual Detector (Stitching Patient Support) 712022

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. …

Civco Medical Instruments Co. Inc.

FDA Devices Moderate Aug 29, 2018

Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 863086 863317 863287 863288 863289 The…

Philips Electronics North America Corporation

FDA Devices Moderate Aug 29, 2018

Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and neonatal patients, and where …

Philips Electronics North America Corporation

FDA Devices Moderate Aug 29, 2018

Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cy…

Euro Diagnostica AB

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost Single Detector (Stitching Patient Support) 712020

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

EasyDiagnost Eleva DRF (Stitching Patient Support) 706032

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation screws and s…

TriMed Inc.

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine System is intended to provide immobili…

Back 2 Basics Direct LLC

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axess…

Elekta, Inc.

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost Release 3 (Stitching Patient Support) 712025

Philips Medical Systems Gmbh, DMC

FDA Devices Critical Aug 29, 2018

bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin …

bioMerieux, Inc.

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs monitor is for use by healthcare professionals whenever t…

Philips Electronics North America Corporation

FDA Devices Moderate Aug 29, 2018

Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedur…

Zimmer Biomet, Inc.

FDA Devices Moderate Aug 29, 2018

GE Healthcare Optima CT660. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold only ou…

GE Healthcare Japan Corporation

FDA Devices Low Aug 29, 2018

is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in hu…

Euro Diagnostica AB

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost Release 3 (Stitching Patient Support) 712025

Philips Medical Systems Gmbh, DMC

FDA Devices Low Aug 29, 2018

is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid…

Euro Diagnostica AB

FDA Devices Moderate Aug 29, 2018

3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is movea…

Siemens Medical Solutions USA, Inc

FDA Devices Critical Aug 29, 2018

CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to an end user s face and a CPAP…

Compass Health Brands (Corporate Office)

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost Upgrades (Stitching Patient Support) 712083

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve, -3.25 Power. Master Lot, containing 12 split lots, repackaged in 30 an…

Johnson & Johnson Vision Care, Inc.

FDA Devices Low Aug 29, 2018

is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies spe…

Euro Diagnostica AB

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multip…

Arrow International Inc

FDA Devices Moderate Aug 29, 2018

Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be use…

Ortho Kinematics, Inc

FDA Devices Moderate Aug 29, 2018

Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomograph…

Hitachi Medical Systems America Inc

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery of Neisseria gonorrhoeae and better …

Becton Dickinson & Co.

FDA Devices Moderate Aug 29, 2018

Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological

Ortho Kinematics, Inc

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the d…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Aug 29, 2018

GE Healthcare Optima CT660. Sold under the following product names: BEIJING OPTIMA CT660 PRO GT170, BEIJING OPTIMA CT660 PRO GT200, BEIJING O…

GE Healthcare Japan Corporation

FDA Devices Moderate Aug 29, 2018

Handicare C Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another.

Handicare Usa Inc

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000

O-Two Medical Technologies, Inc.

FDA Devices Moderate Aug 29, 2018

Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs VS2 vital signs monitor is for use by healthcare pro…

Philips Electronics North America Corporation

FDA Devices Moderate Aug 29, 2018

EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software applicat…

Ortho Kinematics, Inc

FDA Devices Moderate Aug 29, 2018

Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requi…

LIEBEL-FLARSHEIM COMPANY LLC

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost 4.1 (Stitching Patient Support) 712225

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

MOSAIQ Oncology Information System

Elekta, 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