PlainRecalls

2018 Recalls

Compiled from official public sources by the editorial team.

7,717 recalls · Page 149 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 2 critical, 45 moderate, and 3 lower-severity recalls. The page references 23 distinct recalling firms operating in 5 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (29), FDA Drug (15), FDA Food (6), 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 Critical Jan 24, 2018

Frozen Tuna Fillet Saku (Restaurant Supply Only); 22 lbs./2 x 5 kgs. Wild caught: Handline with Hook. Keep Frozen - 18 degrees C or below Produ…

H.I.G. Corporation

FDA Food Moderate Jan 24, 2018

Badusha, 1 lb. clear plastic clamshell containers.

New Punjab Sweets Inc.

FDA Food Critical Jan 24, 2018

Polly Ann Green Bean Ice Cream Bar 4 BARS-2.5 FL. OZ. (75mL) TOTAL 10 FL. OZ. (300mL) UPC 7 00730 26666 9

California Popsicle, Inc.

FDA Food Moderate Jan 24, 2018

Besan Burfi, 1 lb. clear plastic clamshell containers.

New Punjab Sweets Inc.

FDA Food Low Jan 24, 2018

Seasoning Blend- S.E. Meats (Diced red peppers, green peppers, celery and onions) Net weight 1300 LB in TOTE (Plastic liner, corrugated totes)

Paris Foods Corporation

FDA Food Moderate Jan 24, 2018

Besan Ladoo, 1 lb. clear plastic clamshell containers.

New Punjab Sweets Inc.

FDA Drug Moderate Jan 24, 2018

Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in a) 2mL, …

SHISEIDO AMERICA INC.

FDA Drug Moderate Jan 24, 2018

Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel…

Pharmatech LLC

FDA Drug Moderate Jan 24, 2018

Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. L…

Pharmatech LLC

FDA Drug Low Jan 24, 2018

Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Manufactured by Halo Pharmaceuti…

Shionogi Inc.

FDA Drug Moderate Jan 24, 2018

Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 …

SHISEIDO AMERICA INC.

FDA Drug Moderate Jan 24, 2018

Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Davis Ave Cleveland, MS, NDC 71…

Pharmedium Services, LLC

FDA Drug Moderate Jan 24, 2018

ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes, packaged in a) 5-count cartons, NDC…

Pharmedium Services, LLC

FDA Drug Moderate Jan 24, 2018

Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.

AVKARE Inc.

FDA Drug Moderate Jan 24, 2018

Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, Meerut Road, …

Unichem Pharmaceuticals Usa Inc

FDA Drug Moderate Jan 24, 2018

bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bottle, Dist. by Bare Escentuals B…

SHISEIDO AMERICA INC.

FDA Drug Moderate Jan 24, 2018

Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. …

Pharmatech LLC

FDA Drug Moderate Jan 24, 2018

Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%)…

SHISEIDO AMERICA INC.

FDA Drug Low Jan 24, 2018

Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: H…

Hetero Labs, Ltd. - Unit III

FDA Drug Moderate Jan 24, 2018

Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged…

SHISEIDO AMERICA INC.

FDA Drug Moderate Jan 24, 2018

Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N L…

Pharmatech LLC

FDA Devices Moderate Jan 24, 2018

PROPONENT SR Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Jan 24, 2018

TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate Sys…

SPINEART SA

FDA Devices Moderate Jan 24, 2018

TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate Sys…

SPINEART SA

FDA Devices Moderate Jan 24, 2018

Phadia 1000 Instrument, Article Number 12-3800-01.

Phadia US Inc

FDA Devices Moderate Jan 24, 2018

Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at d…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jan 24, 2018

Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter

Stryker Neurovascular

FDA Devices Moderate Jan 24, 2018

ACCOLADE DR Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Jan 24, 2018

ACCOLADE SR Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Jan 24, 2018

Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles f…

Owen Mumford USA, Inc.

FDA Devices Moderate Jan 24, 2018

ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG o…

Philips Electronics North America Corporation

FDA Devices Moderate Jan 24, 2018

PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed …

TEI Biosciences

FDA Devices Moderate Jan 24, 2018

ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS…

Fujifilm Medical Systems U.S.A., Inc.

FDA Devices Moderate Jan 24, 2018

VISIONIST CRT-P Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Jan 24, 2018

Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles f…

Owen Mumford USA, Inc.

FDA Devices Moderate Jan 24, 2018

LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older wh…

Zoll Manufacturing Corp.

FDA Devices Moderate Jan 24, 2018

ESSENTIO DR Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Jan 24, 2018

ALTRUA 2 EL DR Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Jan 24, 2018

ACCOLADE MRI EL DR Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Jan 24, 2018

Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow system indicated for the administra…

Valeant Pharmacueticals International

FDA Devices Moderate Jan 24, 2018

PROPONENT DR Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Jan 24, 2018

TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate Sys…

SPINEART SA

FDA Devices Moderate Jan 24, 2018

VALITUDE CRT-P Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Jan 24, 2018

PROPONENT EL DR Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Jan 24, 2018

Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jan 24, 2018

ACCOLADE MRI DR Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Jan 24, 2018

ACCOLADE MRI SR Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Jan 24, 2018

DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, …

DeRoyal Industries Inc

FDA Devices Moderate Jan 24, 2018

TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45 18-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate Sys…

SPINEART SA

FDA Devices Moderate Jan 24, 2018

TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate Sy…

SPINEART SA

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