PlainRecalls

2018 Recalls

6,355 recalls · Page 19 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 4 critical, 44 moderate, and 2 lower-severity recalls. The page references 12 distinct recalling firms operating in 4 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (31), FDA Drug (19), 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 Moderate Nov 7, 2018

Sermorelin/Ipamorelin 18 mg/15 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1759-18

Pharm D Solutions, LLC

FDA Drug Moderate Nov 7, 2018

HCG Reconstitued 50,000 IU Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1736-50

Pharm D Solutions, LLC

FDA Drug Moderate Nov 7, 2018

Magnesium 40 gm/ns 1000 mL IV, Pharm D Solutions, Houston, Texas --- NDC 69699-0904-10

Pharm D Solutions, LLC

FDA Drug Moderate Nov 7, 2018

Trimix T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg Injectable Pharm D Solutions, Houston, Texas --- NDC 69699-1351-05

Pharm D Solutions, LLC

FDA Drug Moderate Nov 7, 2018

Vigamox Oph. Solution Pharm D Solutions, Houston, Texas --- NDC 69699-0304-05

Pharm D Solutions, LLC

FDA Drug Moderate Nov 7, 2018

Zinc Sulfate 1 mg/mL MDV Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1418-10

Pharm D Solutions, LLC

FDA Drug Moderate Nov 7, 2018

Arnica Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0032-1

Sprayology

FDA Drug Moderate Nov 7, 2018

Calcium Gluconate 10%, 100 mg/mL Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-0914-30

Pharm D Solutions, LLC

FDA Drug Moderate Nov 7, 2018

Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas NDC 69699-1414-20

Pharm D Solutions, LLC

FDA Drug Moderate Nov 7, 2018

QM-4A Quadmix 5 mL 30 PA-2PH-150A-Atropine 0.4 mg Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1342-05

Pharm D Solutions, LLC

FDA Drug Moderate Nov 7, 2018

HCG 3000 Unit Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1738-10

Pharm D Solutions, LLC

FDA Drug Moderate Nov 7, 2018

Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1367-02

Pharm D Solutions, LLC

FDA Drug Moderate Nov 7, 2018

Calcium Gluconate 1% Eyewash Oph. Soln, 10 mg/mL, 1000 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0907-10

Pharm D Solutions, LLC

FDA Drug Moderate Nov 7, 2018

Bone Builder, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0012-1 and Tester NDC 61096-1…

Sprayology

FDA Drug Moderate Nov 7, 2018

Calcium Gluconate1% Eyewash 10 mg/mL, 125 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0906-12

Pharm D Solutions, LLC

FDA Drug Moderate Nov 7, 2018

Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL), Pharm D Solutions, Houston, Texas --- NDC 69699-1323-05

Pharm D Solutions, LLC

FDA Drug Moderate Nov 7, 2018

Lipo MIC-12 Compound Injectable a) NDC 69699-1603-10; b) 30 mL Stock Solution Compound Injectable NDC 69699-1603-30, Pharm D Solutions, Houston, Texas

Pharm D Solutions, LLC

FDA Drug Moderate Nov 7, 2018

Phenol 7% and Glycerin Aqueous Solution 10 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1432-10

Pharm D Solutions, LLC

FDA Drug Moderate Nov 7, 2018

Trimix ST-1 30PA-1.5PH-50A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1388-05

Pharm D Solutions, LLC

FDA Devices Moderate Nov 7, 2018

IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-s…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Nov 7, 2018

Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-80-14.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pal…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Product Usage: The BD MAX System, used in conjunction with appropriate ex…

Becton Dickinson & Co.

FDA Devices Moderate Nov 7, 2018

Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product Usage - The Hoffmann LRF System is indicated in pediatric patien…

Stryker GmbH

FDA Devices Moderate Nov 7, 2018

Zilver 518 Biliary Stent 5mm x 30mm, Catalog Number: ZIB5-125-5.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pall…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX System, used i…

Becton Dickinson & Co.

FDA Devices Moderate Nov 7, 2018

Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-80-5.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palli…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Im…

Philips Medical Systems (Cleveland) Inc

FDA Devices Critical Nov 7, 2018

EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonun…

Zimmer Biomet, Inc.

FDA Devices Moderate Nov 7, 2018

Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-80-12.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pal…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-125-14.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pa…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-125-14.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pa…

Cook Medical Incorporated

FDA Devices Low Nov 7, 2018

Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an op…

Beckman Coulter Inc.

FDA Devices Moderate Nov 7, 2018

IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Liquid, Used f…

CMP Industries, Llc

FDA Devices Critical Nov 7, 2018

Cardiosave Hybrid IABP, Part Number 0998-00-0800-53

Maquet Datascope Corp - Cardiac Assist Division

FDA Devices Low Nov 7, 2018

Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman Coulter, Inc. The Sorting-Drive Plus…

Beckman Coulter Inc.

FDA Devices Moderate Nov 7, 2018

Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce c…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Nov 7, 2018

Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-125-5.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pall…

Cook Medical Incorporated

FDA Devices Critical Nov 7, 2018

Cardiosave Rescue IABP, Part Number 0998-UC-0800-83

Maquet Datascope Corp - Cardiac Assist Division

FDA Devices Moderate Nov 7, 2018

3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish and 1 applic…

3M Company - Health Care Business

FDA Devices Moderate Nov 7, 2018

Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-125-5.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pall…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-80-5.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palli…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-125-14.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pa…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pall…

Cook Medical Incorporated

FDA Devices Critical Nov 7, 2018

SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adju…

Zimmer Biomet, Inc.

FDA Devices Moderate Nov 7, 2018

Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-125-14.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pa…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient thro…

Baxter Healthcare Corporation

FDA Devices Moderate Nov 7, 2018

Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Imag…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Nov 7, 2018

EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient thr…

Baxter Healthcare Corporation

FDA Devices Moderate Nov 7, 2018

Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-80-12.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for pal…

Cook Medical Incorporated

FDA Devices Moderate Nov 7, 2018

EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient thr…

Baxter Healthcare Corporation

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