2018 Recalls

Compiled from official public sources by the editorial team.

7,717 recalls · Page 152 of 155

2018 Recall Year Insight

Federal agencies issued 7,717 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.70% of the 100,165 total recalls we track from 1995 through the present, and averages roughly 21.1 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 155 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 3 critical, 47 moderate, and 0 lower-severity recalls. The page references 22 distinct recalling firms operating in 6 distinct product categories, with 48 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Drug (24), FDA Devices (23), NHTSA (2), 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.

2018 Recalls

2018 Recall Year Insight

Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce…

Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 3348…

Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

7-Keto DHEA 25mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, …

Human Chorionic Gonadotropin 5,000 iu/ Vial Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 334…

FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg SMT G EP PR KR, c) 20 mg SMT G EP PR, d) 20 mg SMT G EP PR …

Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized - For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 3…

Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL…

Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct. Li…

Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufactured in Can…

Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global…

Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton,…

Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Sm…

T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL), For Intracavernouse Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 …

Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL …

QUADMIX #16, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

7-Ketodehydroepiandrosterone (7-Keto DHEA) 100 mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. , Manufactured For: Method Pharmaceuticals, LLC Arlington, TX 76…

Hydroxocobalamin 1 mg/mL 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046 INDIA, NDC 43598…

Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.

Mac Pin Non-Cannulated Screw, 6.5 x 60mm

Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization of the patient, including, b…

EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery.

Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left

Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualization of the patient, including,…

Philips Healthcare Brilliance iCT computed tomography x-ray system

Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump mod…

Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tree.

HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS22409, RMS…

Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude …

Philips Healthcare Brilliance iCT SP computed tomography x-ray system

DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.

LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s …

Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, including, b…

Philips Healthcare IQon Spectral CT computed tomography x-ray system

Sundream 12 V tanning bed

Mobile Mini C-arm system Part # 1000-0005. Intended to provide the physician with general fluoroscopic visualization of the patient, including, b…

Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump…

EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.

CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all r…

EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery.

UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z, DFP170-6121, DF3115-6121Z, DF3…

Fujifilm Recalls Power Adapter Wall Plugs Sold with Digital Cameras Due to Shock Hazard

FORD,LINCOLN 2018: VISIBILITY:POWER WINDOW DEVICES AND CONTROLS

MAZDA 2006: AIR BAGS:FRONTAL:PASSENGER SIDE:INFLATOR MODULE

Nearby Recall Years

Data Sources