PlainRecalls

2018 Recalls

6,355 recalls · Page 58 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 21 critical, 27 moderate, and 2 lower-severity recalls. The page references 21 distinct recalling firms operating in 2 distinct product categories, with 43 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Drug (29), FDA Devices (21), 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 Critical Jul 18, 2018

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

Gaia Ethnobotanical LLC

FDA Drug Critical Jul 18, 2018

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

Gaia Ethnobotanical LLC

FDA Drug Low Jul 18, 2018

Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American Health Pac…

AMERICAN HEALTH PACKAGING

FDA Drug Critical Jul 18, 2018

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

Gaia Ethnobotanical LLC

FDA Drug Critical Jul 18, 2018

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

Gaia Ethnobotanical LLC

FDA Drug Low Jul 18, 2018

Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-f…

Wockhardt Limited

FDA Drug Critical Jul 18, 2018

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

Gaia Ethnobotanical LLC

FDA Drug Critical Jul 18, 2018

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

Gaia Ethnobotanical LLC

FDA Drug Critical Jul 18, 2018

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

Gaia Ethnobotanical LLC

FDA Drug Critical Jul 18, 2018

Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx Only. Manufactured for: Auromedics Pharma LLC 6 Wheeling Roa…

AuroMedics Pharma LLC

FDA Drug Moderate Jul 18, 2018

Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGyn Produc…

Medgyn Products, Inc.

FDA Drug Critical Jul 18, 2018

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

Gaia Ethnobotanical LLC

FDA Drug Critical Jul 18, 2018

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

Gaia Ethnobotanical LLC

FDA Drug Critical Jul 18, 2018

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

Gaia Ethnobotanical LLC

FDA Drug Critical Jul 18, 2018

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

Gaia Ethnobotanical LLC

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 Sampl…

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 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 8410…

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., B…

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, 250…

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…

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 (…

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 ther…

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…

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…

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/Disinfecto…

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 u…

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 numbe…

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 ther…

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 sys…

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 Produ…

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

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