PlainRecalls

2018 Recalls

Compiled from official public sources by the editorial team.

7,717 recalls · Page 124 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 1 critical, 44 moderate, and 5 lower-severity recalls. The page references 25 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 (34), FDA Drug (13), FDA Food (3), 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 Food Moderate Mar 14, 2018

Dr Pepper, 12 oz (355 mL) cans, packed in 12 and 24 packs, Canned under the authority of Dr Pepper Company, Plano, TX

Heartland Coca-Cola Bottling Company

FDA Food Moderate Mar 14, 2018

Pibb Xtra, Artificially Flavored Spicy Cherry Soda 12 oz (355 mL) cans, packed in 12 packs, Canned under the authority of the Coca-Cola Company, Atla…

Heartland Coca-Cola Bottling Company

FDA Food Moderate Mar 14, 2018

Mello Yello, Citrus Flavored Soda, 12 oz (355 mL) cans, packed in 12 packs, Canned under the authority of the Coca-Cola Company, Atlanta, GA

Heartland Coca-Cola Bottling Company

FDA Drug Moderate Mar 14, 2018

Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1

Spirit Pharmaceuticals, LLC

FDA Drug Moderate Mar 14, 2018

RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured by: Amneal Pharmaceuticals, Hauppauge, NY 11788, NDC 63739-489-10

Mckesson Packaging Services

FDA Drug Moderate Mar 14, 2018

Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, IL 60045, N…

Hospira Inc. A Pfizer Company

FDA Drug Moderate Mar 14, 2018

Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.

Apollo Care

FDA Drug Low Mar 14, 2018

Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra Zeneca Pharmaceuticals LP Wilmington, DE 19850 by: Patheon …

AstraZeneca Pharmaceuticals LP

FDA Drug Low Mar 14, 2018

Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-…

Akorn, Inc.

FDA Drug Moderate Mar 14, 2018

Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-264-2…

Apollo Care

FDA Drug Critical Mar 14, 2018

Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural 304 E 11th Street, Los Angeles, CA 90015

Bella All Natural

FDA Drug Moderate Mar 14, 2018

Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bottle, Dist. by: Bayer Healthc…

Bayer HealthCare Pharmaceuticals, Inc.

FDA Drug Moderate Mar 14, 2018

Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Kalchem Inte…

Kalchem International, Inc.

FDA Drug Low Mar 14, 2018

Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13…

Osmotica Pharmaceutical Corp

FDA Drug Low Mar 14, 2018

labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 700…

SCA Pharmaceuticals, LLC.

FDA Drug Low Mar 14, 2018

Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g, Imported for: Shoppers Drug Mart Pharmaprix Toronto, M2J4W8, UPC 05780…

Oxygen Development Llc

FDA Devices Moderate Mar 14, 2018

Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed…

Medtronic Neuromodulation

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 1.1MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7592, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended fo…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.

Boston Scientific Corporation

FDA Devices Moderate Mar 14, 2018

IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 3.2MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7557A, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended fo…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.

Stryker Corporation

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, CLEAR 3.0 MM CLEAR CORNEAL ANGLED KNIFE (6/BOX), REF/PRODUCT CODE E7529, STERILE, Rx Only Product Usage: The LaserEdge Knives …

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

INFX-8000C Fluoroscopic X-Ray Systems

Toshiba American Medical Systems Inc

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 2.4 MM SLIT KNIFE ANGLED DOUBLE BEVEL, REF/PRODUCT CODE E7549ADB, STERILE, Rx Only Product Usage: The LaserEdge Knives are inte…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a me…

Ion Beam Applications S.A.

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7551ADB, STERILE, Rx Only Product Usage: The LaserEdge Knives…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, CRESCENT BLADE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE E7510, STERILE, Rx Only Product Usage: The LaserEdge Knives are int…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 30 DEGREE STAB BLADE TIP (6/BOX), REF/PRODUCT CODE E7530T, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended f…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL GUARDED (6/BOX), REF/PRODUCT CODE E7551ADBG, STERILE, Rx Only Product Usage: The LaserEd…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7) Product Usage: The A-Series Anesthesia System is a device used to admi…

Mindray DS USA, Inc. dba Mindray North America

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 20 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7520, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for opht…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, CRESCENT BLADE ANGLED TIP BEVEL UP (6/BOX), REF/PRODUCT CODE E7510AT, STERILE, Rx Only Product Usage: The LaserEdge Knives are i…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 2.8MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7552ADB, STERILE, Rx Only Product Usage: The LaserEdge Knives …

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 15 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7515, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for …

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 2.5 MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7550A, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended f…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 02.00020.040

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 2.85MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7553A, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended f…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7601, STERILE, Rx Only Product Usage: The LaserEdge Knives are intende…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.855MM GUARDED (6/BOX), REF/PRODUCT CODE E7528G, STERILE, Rx Only Product Usage: The LaserEdge Knives ar…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system. There are 11 segments with each cuvet…

Abbott Laboratories, Inc

FDA Devices Moderate Mar 14, 2018

INFX-8000F Fluoroscopic X-Ray Systems

Toshiba American Medical Systems Inc

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7556A, STERILE, Rx Only Product Usage: The LaserEdge Knives ar…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic

Ortho-Clinical Diagnostics

FDA Devices Moderate Mar 14, 2018

Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.

Boston Scientific Corporation

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 2.5 MM SLIT KNIFE BEVEL UP ANGLED GUARDED(6/BOX), REF/PRODUCT CODE E7550AG, STERILE, Rx Only Product Usage: The LaserEdge Kniv…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

LASEREDGE Knives, 2.6 MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7550ADB, STERILE, Rx Only Product Usage: The LaserEdge Knives…

Bausch & Lomb Inc Irb

FDA Devices Moderate Mar 14, 2018

Proteus 235, graphite block 8

Ion Beam Applications S.A.

FDA Devices Moderate Mar 14, 2018

Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumb…

DePuy Orthopaedics, Inc.

FDA Devices Moderate Mar 14, 2018

VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic

Ortho-Clinical Diagnostics

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