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 9 critical, 41 moderate, and 0 lower-severity recalls. The page references 19 distinct recalling firms operating in 2 distinct product categories, with 41 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (36), FDA Drug (14), 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 Drug Critical Jul 18, 2018

Gaia Kratom (mitragyna speciosa) powder, Red Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Gaia Ethnobotanical LLC

FDA Drug Critical Jul 18, 2018

Gaia Kratom (mitragyna speciosa) powder, Green Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Gaia Ethnobotanical LLC

FDA Drug Moderate Jul 18, 2018

Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.

Akorn, Inc.

FDA Drug Moderate Jul 18, 2018

Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0024-5925-00

Sanofi-Aventis U.S. LLC

FDA Drug Critical Jul 18, 2018

Gaia Kratom (mitragyna speciosa) powder, Red MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Gaia Ethnobotanical LLC

FDA Drug Critical Jul 18, 2018

Gaia Kratom (mitragyna speciosa) powder, White Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Gaia Ethnobotanical LLC

FDA Drug Critical Jul 18, 2018

Gaia Kratom (mitragyna speciosa) powder, Plantation White MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Gaia Ethnobotanical LLC

FDA Drug Moderate Jul 18, 2018

Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11

LUPIN SOMERSET

FDA Drug Moderate Jul 18, 2018

Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60.

Teva Pharmaceuticals USA

FDA Drug Critical Jul 18, 2018

Gaia Kratom (mitragyna speciosa) powder, Purple 8-1, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Gaia Ethnobotanical LLC

FDA Drug Moderate Jul 18, 2018

Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug Pharmaceutical Compounding 300 West Pine St., Blacksburg, SC 29702 800-622-0007

Medi-Fare Drug and Home Health Center

FDA Drug Critical Jul 18, 2018

Gaia Kratom (mitragyna speciosa) powder, Red Bali, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical Red Borneo, 1oz, 250g, kg Gaia Ethnobotanical Red Dragon, 1oz, 250g, 1kg Gaia Ethnobotanical Red Horn, 1oz, 250g, 1kg Gaia Ethnobotanical Red Kapuas Hulu 1oz, 250g, 1kg Gaia Ethnobotanical Red MD, 1oz, 250g, 1kg Gaia Ethnobotanical Red Thai, 1oz, 250g,. 1kg Gaia Ethnobotanical Super Green Malay 1oz, 250g, 1kg Gaia Ethnobotanical White Borneo 1oz, 250g, 1kg Gai

Gaia Ethnobotanical LLC

FDA Drug Critical Jul 18, 2018

Gaia Kratom (mitragyna speciosa) powder, Plantation Red MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Gaia Ethnobotanical LLC

FDA Drug Critical Jul 18, 2018

Gaia Kratom (mitragyna speciosa) powder, Red Borneo, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

Gaia Ethnobotanical LLC

FDA Devices Moderate Jul 18, 2018

Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S

Stryker GmbH

FDA Devices Moderate Jul 18, 2018

BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical systems. Specifically the mini VIDAS system is an immunodiagnostic system intended to be used by trained and qualified laboratory professionals, for In vitro Diagnostic (IVD) purpose, veterinary and industrial applications. Th

bioMerieux, Inc.

FDA Devices Moderate Jul 18, 2018

Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S

Stryker GmbH

FDA Devices Moderate Jul 18, 2018

Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230S

Stryker GmbH

FDA Devices Moderate Jul 18, 2018

Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate Jul 18, 2018

Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate Jul 18, 2018

Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems

GE Medical Systems, SCS

FDA Devices Moderate Jul 18, 2018

Discovery IGS 730 Interventional Fluoroscopic X-ray Systems

GE Medical Systems, SCS

FDA Devices Moderate Jul 18, 2018

Femoral Nail, A/R, R1500 T2 Femur ¿12x360 mm, Product Number 18281236S

Stryker GmbH

FDA Devices Moderate Jul 18, 2018

Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care device. It is comprised of a non-woven pad entirely composed of HY AFF 11, a benzyl ester of hyaluronic acid, and a semipermeable silicone membrane, which controls water vapor loss, provides a flexible covering for the wound surface, and adds increased tear strength to the device. The HYAFFl 1 wound cont

Anika Therapeutics, Inc.

FDA Devices Moderate Jul 18, 2018

Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters t

Arrow International Inc

FDA Devices Moderate Jul 18, 2018

Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theatre shoes and other miscellaneous reusable items used in the care of patients.

Steris Corporation

FDA Devices Moderate Jul 18, 2018

BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.

Medline Industries, Inc.

FDA Devices Moderate Jul 18, 2018

VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally conside

Arrow International Inc

FDA Devices Moderate Jul 18, 2018

Femoral Nail, LEFT T2 GTN ¿14x300 mm, Product Number 18501430S

Stryker GmbH

FDA Devices Moderate Jul 18, 2018

BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbers have to do with certain functions being installed or not installed.) Product Usage: The 9200 vital signs monitor is intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of the hospital or clinic where low end monitoring systems are needed. The basic monitor package includes ECG (3 l

Smiths Medical ASD Inc.

FDA Devices Moderate Jul 18, 2018

Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate Jul 18, 2018

Femoral Nail, RIGHT T2 GTN ¿14x460 mm, Product Number 18511446S

Stryker GmbH

FDA Devices Moderate Jul 18, 2018

Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebral spinal fluid (CSF). The CrAg Lateral Flow Assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis.

Immuno-Mycologics, Inc

FDA Devices Moderate Jul 18, 2018

da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.

Intuitive Surgical, Inc.

FDA Devices Moderate Jul 18, 2018

Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhyth

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate Jul 18, 2018

VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered

Arrow International Inc

FDA Devices Moderate Jul 18, 2018

Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S

Stryker GmbH

FDA Devices Moderate Jul 18, 2018

Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate Jul 18, 2018

Femoral Nail, A/R T2 Femur ¿10x340 mm, Product Number 18251034S

Stryker GmbH

FDA Devices Moderate Jul 18, 2018

Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154VRC Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate Jul 18, 2018

Femoral Nail, A/R T2 Femur ¿15x240 mm, Product Number 18251524S

Stryker GmbH

FDA Devices Moderate Jul 18, 2018

Femoral Nail, LEFT T2 GTN ¿10x360 mm, Product Number 18501036S

Stryker GmbH

FDA Devices Moderate Jul 18, 2018

Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S

Stryker GmbH

FDA Devices Moderate Jul 18, 2018

Femoral Nail, RIGHT T2 GTN ¿9x320 mm, Product Number 18510932S

Stryker GmbH

FDA Devices Moderate Jul 18, 2018

Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: The Reprocessed CS Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

Stryker Sustainability Solutions

FDA Devices Moderate Jul 18, 2018

Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhyth

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate Jul 18, 2018

Discovery IGS 740 Interventional Fluoroscopic X-ray Systems

GE Medical Systems, SCS

FDA Devices Moderate Jul 18, 2018

PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.

Dako North America Inc.

FDA Devices Moderate Jul 18, 2018

Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S

Stryker GmbH

FDA Devices Moderate Jul 18, 2018

BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical systems. Specifically the mini VIDAS system is an immunodiagnostic system intended to be used by trained and qualified laboratory professionals, for In vitro Diagnostic (IVD) purpose, veterinary and industrial application

bioMerieux, 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.