PlainRecalls

2018 Recall Year Insight

Federal agencies issued 7,928 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.59% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 21.7 recalls per day across the FDA, CPSC, USDA FSIS, 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 159 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, 42 moderate, and 5 lower-severity recalls. The page references 28 distinct recalling firms operating in 7 distinct product categories, with 45 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (32), FDA Drug (9), 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, USDA FSIS, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate Jul 4, 2018

Ingenuity TF PET/CT 882442

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jul 4, 2018

Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682

Randox Laboratories Ltd.

FDA Devices Moderate Jul 4, 2018

Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684

Randox Laboratories Ltd.

FDA Devices Moderate Jul 4, 2018

Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

St Jude Medical Inc.

FDA Devices Moderate Jul 4, 2018

Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000

Intersurgical Inc

FDA Devices Moderate Jul 4, 2018

OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025

Philips Medical Systems Nederlands

FDA Devices Moderate Jul 4, 2018

Artis zee ceiling, Material no. 10094137, for angiography and whole body radiographic/fluoroscopic procedures.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Jul 4, 2018

Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004

Exsurco Medical

FDA Devices Moderate Jul 4, 2018

Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 1001

St Jude Medical Inc.

FDA Devices Moderate Jul 4, 2018

Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656,

St Jude Medical Inc.

FDA Devices Moderate Jul 4, 2018

Ingenuity Core128/Elite China 728324

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jul 4, 2018

RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The inten

RAYSEARCH LABORATORIES AB

FDA Devices Moderate Jul 4, 2018

Artis zee floor, Material no. 10094135, for angiography and whole body radiographic/fluoroscopic procedures.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Jul 4, 2018

Artis Q.zen biplane, Material no. 10848355, for angiography and whole body radiographic/fluoroscopic procedures.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Jul 4, 2018

Artis zee floor MN, Material no. 10094142, for angiography and whole body radiographic/fluoroscopic procedures.

Siemens Medical Solutions USA, Inc

USDA FSIS Low Jul 2, 2018

Recall Notification Report 058-2018 (Pork Products)

Nueske's Meat Products, Inc.

CPSC No agency class Jun 29, 2018

BRP Recalls All-Terrain Vehicles Due to Fuel Leak and Fire Hazard (Recall Alert)

CPSC No agency class Jun 29, 2018

Helmets R Us Recalls Helmets Due to Risk of Head Injury (Recall Alert)

Strategic Sports Ltd., of Hong Kong

USDA FSIS Critical Jun 29, 2018

L&D Market, Inc. Recalls Chicken Wrap Products Due to Misbranding and Undeclared Allergens

L&D Market Inc.

NHTSA No agency class Jun 28, 2018

BMW 2018: SUSPENSION:FRONT:CONTROL ARM:LOWER ARM

BMW

NHTSA No agency class Jun 28, 2018

CADILLAC 2016-2018: SEATS:MID/REAR ASSEMBLY

CADILLAC

FDA Food Critical Jun 27, 2018

Kellogg's Honey Smacks, 15.3 oz. and 23 oz.

Kellogg Company

FDA Food Low Jun 27, 2018

Melissa's Spicy Edamame: Lightly seasoned with Japanese Chile and Sesame Oil. 7 oz. (1.98g) Keep Refrigerated UPC: 0-45255-14637 6 count and 12 count cases; Ingredients: Soybeans, water Sesame oil, Soy Sauce (soy Beans, Wheat and salt) Rice Wine vinegar, Chaotian chile, pepper, sugar, garlic, sodium glutamate. Flavoring packet included contains oyster sauce that is not declared. Label does state that product is manufactured in a facility that processes milk, egg, shellfish, tree nuts

World Variety Produce Inc.

FDA Food Moderate Jun 27, 2018

H-E-B Ode to Olives, Sliced Salad Olives, 10 oz. drained weight per jar/ 6 jars per case (this product is sold by the jar at the store level, not by the case), Best by November 3, 2019.

Agro Sevilla USA

FDA Drug Low Jun 27, 2018

Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA

Dr. Reddy's Laboratories, Inc.

FDA Drug Low Jun 27, 2018

Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-122-90

Dr. Reddy's Laboratories, Inc.

FDA Drug Moderate Jun 27, 2018

0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02

ICU Medical Inc

FDA Drug Moderate Jun 27, 2018

Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900

Dr. Reddy's Laboratories, Inc.

FDA Drug Moderate Jun 27, 2018

5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02

ICU Medical Inc

FDA Drug Low Jun 27, 2018

Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90

Dr. Reddy's Laboratories, Inc.

FDA Drug Moderate Jun 27, 2018

0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37

ICU Medical Inc

FDA Drug Moderate Jun 27, 2018

0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23

ICU Medical Inc

FDA Drug Moderate Jun 27, 2018

0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37

ICU Medical Inc

FDA Devices Moderate Jun 27, 2018

G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

Zimmer Biomet, Inc.

FDA Devices Moderate Jun 27, 2018

The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays.

Becton Dickinson & Company

FDA Devices Moderate Jun 27, 2018

G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL DRIVING GUIDE 4.4MM X 80CM; 467220 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

Zimmer Biomet, Inc.

FDA Devices Moderate Jun 27, 2018

3.2MM X 560MM COCR THD TIP; 14-441053 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

Zimmer Biomet, Inc.

FDA Devices Moderate Jun 27, 2018

Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set

Synthes (USA) Products LLC

FDA Devices Moderate Jun 27, 2018

BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

Zimmer Biomet, Inc.

FDA Devices Moderate Jun 27, 2018

CritiCore Automated Urine Output and Temperature Monitor

C.R. Bard, Inc.

FDA Devices Moderate Jun 27, 2018

RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

Zimmer Biomet, Inc.

FDA Devices Moderate Jun 27, 2018

Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e) ES-12x15x17; f) ES-12x16x19; g) ES-15x13x16

TriMed Inc.

FDA Devices Moderate Jun 27, 2018

Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22

TriMed Inc.

FDA Devices Moderate Jun 27, 2018

Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures.

Vascular Solutions, Inc.

FDA Devices Moderate Jun 27, 2018

CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume. Additional respiratory gas monitoring capabilities are supported throug

Datex-Ohmeda, Inc.

FDA Devices Moderate Jun 27, 2018

Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 mm, REF 74120164 (c) Size 54 mm, REF 74122154 (d) Size 58 mm, REF 74122158 (e) Size 60 mm, REF 74122160 (f) Size 62 mm, REF 74122162

Smith & Nephew, Inc.

FDA Devices Moderate Jun 27, 2018

Olympus JF-140F duodenoscopes (Model NumberJF-140F)

Olympus Corporation of the Americas

FDA Devices Moderate Jun 27, 2018

Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463

Stryker GmbH

FDA Devices Moderate Jun 27, 2018

GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

Zimmer Biomet, Inc.

FDA Devices Moderate Jun 27, 2018

The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays.

Becton Dickinson & Company

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: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2018

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