PlainRecalls

2018 Recalls

6,355 recalls · Page 62 of 128

2018 Recall Year Insight

Federal agencies issued 6,355 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.57% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 17.4 recalls per day across the FDA, CPSC, NHTSA, and USDA FSIS 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 128 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, 44 moderate, and 4 lower-severity recalls. The page references 27 distinct recalling firms operating in 5 distinct product categories, with 47 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (35), FDA Drug (9), CPSC (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, NHTSA, or USDA FSIS 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

Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230…

St Jude Medical Inc.

FDA Devices Moderate Jul 4, 2018

Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresites, ASV with…

B. Braun Medical, Inc.

FDA Devices Moderate Jul 4, 2018

Artis Q ceiling, Material no. 10848281, for angiography and whole body radiographic/fluoroscopic procedures.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Jul 4, 2018

Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 1…

St Jude Medical Inc.

FDA Devices Moderate Jul 4, 2018

Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage: general surgical scissors

Teleflex Medical Europe Ltd

FDA Devices Moderate Jul 4, 2018

Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100…

St Jude Medical Inc.

FDA Devices Moderate Jul 4, 2018

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369…

St Jude Medical Inc.

FDA Devices Moderate Jul 4, 2018

Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807

Safe N Simple, LLC

FDA Devices Moderate Jul 4, 2018

ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Jul 4, 2018

Artis zee biplane MN, Material no. 10094143, for angiography and whole body radiographic/fluoroscopic procedures.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Jul 4, 2018

Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Jul 4, 2018

ImagePilot, Model No. D9MA

Konica Minolta Medical Imaging USA, Inc.

FDA Devices Moderate Jul 4, 2018

Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001, 60013879-30…

St Jude Medical Inc.

FDA Devices Moderate Jul 4, 2018

Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636;…

St Jude Medical Inc.

FDA Devices Moderate Jul 4, 2018

Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be damaged and may fail to start up when the …

Toshiba American Medical Systems Inc

FDA Devices Moderate Jul 4, 2018

Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-307, 60010742…

St Jude Medical Inc.

FDA Devices Moderate Jul 4, 2018

Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The product is intended for use in…

Zimmer Biomet, Inc.

FDA Devices Moderate Jul 4, 2018

The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)

Ion Beam Applications S.A.

FDA Devices Moderate Jul 4, 2018

HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Cl…

Cenorin, LLC

FDA Devices Moderate Jul 4, 2018

OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028

Philips Medical Systems Nederlands

CPSC Moderate Jun 29, 2018

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

CPSC Moderate Jun 29, 2018

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

Strategic Sports Ltd., of Hong Kong

NHTSA Critical Jun 28, 2018

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

BMW

NHTSA Moderate 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 …

World Variety Produce Inc.

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, 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…

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…

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…

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). …

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,…

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 (cannulate…

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…

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 nail…

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). …

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…

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 i…

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 ventilatio…

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 (…

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

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 + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2018