PlainRecalls

2018 Recalls

6,355 recalls · Page 32 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 1 critical, 45 moderate, and 4 lower-severity recalls. The page references 16 distinct recalling firms operating in 2 distinct product categories, with 47 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (43), FDA Drug (7), 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 Drug Low Oct 3, 2018

Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland Pharma Limited D.P. Pally - 500 043…

Dr. Reddy's Laboratories, Inc.

FDA Drug Moderate Oct 3, 2018

Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida …

Noven Pharmaceuticals, Inc.

FDA Drug Low Oct 3, 2018

Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy'…

Dr. Reddy's Laboratories, Inc.

FDA Drug Critical Oct 3, 2018

Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, I…

Hetero Labs Limited Unit V

FDA Drug Low Oct 3, 2018

Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90

Hetero Labs, Ltd. - Unit III

FDA Drug Low Oct 3, 2018

Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) C…

Baxter Healthcare Corporation

FDA Drug Moderate Oct 3, 2018

Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. M…

Noven Pharmaceuticals, Inc.

FDA Devices Moderate Oct 3, 2018

AIIuraXperFDlO/10, System Code 722011 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including dia…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 3 Hole Plate Item Number: 2110-135-003 Product Usage: The HipLOC Com…

Biomet UK Ltd.

FDA Devices Moderate Oct 3, 2018

Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG…

CooperSurgical, Inc.

FDA Devices Moderate Oct 3, 2018

INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnosti…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Allura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including di…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications includ…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

HipLOC Hip Fracture Fixation System-Hiploc System 140¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-140-004 Product Usage: The HipLOC Com…

Biomet UK Ltd.

FDA Devices Moderate Oct 3, 2018

Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.…

GE Medical Systems, LLC

FDA Devices Moderate Oct 3, 2018

VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)

Boston Scientific Corporation

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field Elite Pack, REF SE5420W (containing the Stellaris Elite 20 GA Vi…

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

INTEGRIS SUITE, System Code 722199 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagno…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

AIIura Xper F010 DR Table, System Code 722022 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications inclu…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Allura Xper FD2O, System Code 722006 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diag…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

INTEGRIS Allura 9 (biplane), System Code 722021 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications inc…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002

Stryker GmbH

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid-Field Elite Pack, REF SE5423MV (containing the Stellaris Elite 23 GA Vi…

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

Allura Xper FD2O, System Code 722012 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diag…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004 Product Usage: The HipLOC Com…

Biomet UK Ltd.

FDA Devices Moderate Oct 3, 2018

INTEGRIS Allura 15-12 (mono), System Code 722043 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications in…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications includ…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Allura Xper F010/10 DRTable, System Code 722019 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications inc…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wide-Field Elite Pack, REF SE5423WV (containing the Stellaris Elite 23 GA V…

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

PROPONENT Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Oct 3, 2018

Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications includ…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

AlIura Xper F010 F, System Code 722002 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including d…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including dia…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical …

Agfa N.V.

FDA Devices Moderate Oct 3, 2018

Allura Xper F020 DR Table, System Code 722015 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications inclu…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number 185224 Intended for use in Total Knee Arthroplasty

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wide-Field Elite Pack, REF SE5425WV (containing the Stellaris Elite 25 GA V…

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

ACCOLADE Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Oct 3, 2018

G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood spe…

Tosoh Bioscience Inc

FDA Devices Moderate Oct 3, 2018

Allura Xper F010 DR Table, System Code 722014 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications inclu…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper.

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient …

Intuitive Surgical, Inc.

FDA Devices Moderate Oct 3, 2018

Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications inc…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide-Field Elite Pack, REF SE5523WV (containing the Stellaris Elite 23 GA Vi…

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack, REF SE5420M (containing the Stellaris Elite 20 GA Vit…

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide-Field Elite Pack, REF SE5525WV (containing the Stellaris Elite 25 GA Vi…

Bausch & Lomb Inc

FDA Devices Moderate Oct 3, 2018

Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications inclu…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applicatio…

Philips Electronics North America Corporation

FDA Devices Moderate Oct 3, 2018

Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.

Bausch & Lomb 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