PlainRecalls

2018 Recalls

Compiled from official public sources by the editorial team.

7,795 recalls · Page 26 of 156

2018 Recall Year Insight

Federal agencies issued 7,795 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.66% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 21.4 recalls per day across the FDA, CPSC, 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 156 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, 47 moderate, and 1 lower-severity recalls. The page references 16 distinct recalling firms operating in 3 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (33), FDA Drug (17), 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, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Moderate Oct 31, 2018

Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only, Manufa…

Teva Pharmaceuticals USA

FDA Drug Moderate Oct 31, 2018

Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ…

Valeant Pharmaceuticals North America LLC

FDA Drug Moderate Oct 31, 2018

Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale,…

Teva Pharmaceuticals USA

FDA Drug Moderate Oct 31, 2018

ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox 0.0294%, Ketorolac 0.0147%) 1x 1cc syringe, W…

Westlab Pharmacy, Inc. dba Westlab Pharmacy

FDA Drug Moderate Oct 31, 2018

Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale,…

Teva Pharmaceuticals USA

FDA Drug Moderate Oct 31, 2018

Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00

RemedyRepack Inc.

FDA Drug Moderate Oct 31, 2018

Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufac…

Teva Pharmaceuticals USA

FDA Drug Moderate Oct 31, 2018

HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett Company, Inc., Phila…

Lannett Company, Inc.

FDA Drug Moderate Oct 31, 2018

Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00

Westlab Pharmacy, Inc. dba Westlab Pharmacy

FDA Drug Moderate Oct 31, 2018

Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale…

Teva Pharmaceuticals USA

FDA Drug Moderate Oct 31, 2018

Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, …

Teva Pharmaceuticals USA

FDA Drug Moderate Oct 31, 2018

Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11

Upsher Smith Laboratories, Inc.

FDA Drug Moderate Oct 31, 2018

PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and metformin HCl extended -…

Teva Pharmaceuticals USA

FDA Drug Low Oct 31, 2018

Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684

Promise Pharmacy LLC

FDA Drug Moderate Oct 31, 2018

Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11

Upsher Smith Laboratories, Inc.

FDA Drug Moderate Oct 31, 2018

Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America …

Valeant Pharmaceuticals North America LLC

FDA Drug Moderate Oct 31, 2018

Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, …

Teva Pharmaceuticals USA

FDA Devices Moderate Oct 31, 2018

3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixat…

Synthes (USA) Products LLC

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product Number:-D36-14623

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage i…

Nakanishi Inc.

FDA Devices Moderate Oct 31, 2018

APTIO 15000 REFRIGERATED STORAGE MODULE

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number Bl70000027 Product Usage: The O-arm Imaging System is a …

Medtronic Navigation, Inc.-Littleton

FDA Devices Moderate Oct 31, 2018

APTIO RACK INPUT MODULE

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage …

Nakanishi Inc.

FDA Devices Moderate Oct 31, 2018

STREAMLAB CORE UNIT / LYNX WITH IOM

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R Product Usage: The O-arm Imaging System is…

Medtronic Navigation, Inc.-Littleton

FDA Devices Critical Oct 31, 2018

CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.

Alcon Research, LTD.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated micro…

bioMerieux, Inc.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

APTIO INPUT/OUTPUT MODULE

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Oct 31, 2018

Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are intended for su…

Nakanishi Inc.

FDA Devices Moderate Oct 31, 2018

Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z…

Boston Scientific Corporation

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: YMCIR-400

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated…

bioMerieux, Inc.

FDA Devices Moderate Oct 31, 2018

Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for …

Nakanishi Inc.

FDA Devices Moderate Oct 31, 2018

STREAMLAB - REFRIGERATED STORAGE MODULE 9000

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF (3) 1231-140XL GOWN, SPECIALTY XL, XLO…

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB, Model Number Bl70000027GERR Product Usage: The O-arm Imaging …

Medtronic Navigation, Inc.-Littleton

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (als…

Data Innovations, LLC

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit- COBAN¿, LF (1"X5 YDS) Product Number:D5-14591

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model Number Bl70000027230R Product Usage: The O-arm Imaging Sys…

Medtronic Navigation, Inc.-Littleton

FDA Devices Critical Oct 31, 2018

CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.

Alcon Research, LTD.

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 - consumer product and vehicle recall feeds for 2018

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Figures cover calendar year 2018 across the FDA, CPSC 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 July 2026.