PlainRecalls

2018 Recalls

6,355 recalls · Page 13 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 8 critical, 41 moderate, and 1 lower-severity recalls. The page references 24 distinct recalling firms operating in 5 distinct product categories, with 46 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (37), FDA Drug (5), NHTSA (4), 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 Drug Moderate Nov 21, 2018

Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; NDC 0781-1695-01

Sandoz Inc

FDA Drug Moderate Nov 21, 2018

Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- ND…

Teva Pharmaceuticals USA

FDA Drug Critical Nov 21, 2018

puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0.

Kadesh International

FDA Drug Low Nov 21, 2018

Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487, Ma…

Breckenridge Pharmaceutical, Inc.

FDA Drug Moderate Nov 21, 2018

Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC …

Sandoz Inc

FDA Devices Moderate Nov 21, 2018

Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLIS…

GE Healthcare, LLC

FDA Devices Moderate Nov 21, 2018

The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Nov 21, 2018

Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provid…

Zimmer Biomet, Inc.

FDA Devices Moderate Nov 21, 2018

ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for s…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Nov 21, 2018

Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provid…

Zimmer Biomet, Inc.

FDA Devices Moderate Nov 21, 2018

Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro diagnostic t…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Nov 21, 2018

OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G

AROA Biosurgery, LTD.

FDA Devices Moderate Nov 21, 2018

Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT EN…

GE Healthcare, LLC

FDA Devices Moderate Nov 21, 2018

Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: T…

Arrow International Inc

FDA Devices Critical Nov 21, 2018

GE Healthcare Millennium MC

GE Healthcare, LLC

FDA Devices Moderate Nov 21, 2018

Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 The Affixus Hip Fracture Nail System, comprised of short and long nails, p…

Zimmer Biomet, Inc.

FDA Devices Moderate Nov 21, 2018

ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed fo…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Nov 21, 2018

OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G

AROA Biosurgery, LTD.

FDA Devices Critical Nov 21, 2018

GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System

GE Healthcare, LLC

FDA Devices Moderate Nov 21, 2018

Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH…

GE Healthcare, LLC

FDA Devices Moderate Nov 21, 2018

Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The Affixus Hip Fracture Nail System, comprised of short and long nails, pr…

Zimmer Biomet, Inc.

FDA Devices Moderate Nov 21, 2018

OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G

AROA Biosurgery, LTD.

FDA Devices Moderate Nov 21, 2018

OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G

AROA Biosurgery, LTD.

FDA Devices Moderate Nov 21, 2018

Heron toilet and bath chair Model 880505-01 & 880505-11

R82 A/S

FDA Devices Moderate Nov 21, 2018

OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G

AROA Biosurgery, LTD.

FDA Devices Moderate Nov 21, 2018

OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G

AROA Biosurgery, LTD.

FDA Devices Moderate Nov 21, 2018

Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circular in shape,…

Covidien LLC

FDA Devices Moderate Nov 21, 2018

Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test for the …

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Nov 21, 2018

OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G

AROA Biosurgery, LTD.

FDA Devices Moderate Nov 21, 2018

Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip Fracture Nail System, comprised of short and long nails, p…

Zimmer Biomet, Inc.

FDA Devices Moderate Nov 21, 2018

3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumenta…

Arthrex, Inc.

FDA Devices Moderate Nov 21, 2018

VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simulta…

Luminex Corporation

FDA Devices Critical Nov 21, 2018

GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System

GE Healthcare, LLC

FDA Devices Moderate Nov 21, 2018

OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G

AROA Biosurgery, LTD.

FDA Devices Moderate Nov 21, 2018

OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G

AROA Biosurgery, LTD.

FDA Devices Moderate Nov 21, 2018

OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G

AROA Biosurgery, LTD.

FDA Devices Moderate Nov 21, 2018

ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system develope…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Nov 21, 2018

OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G

AROA Biosurgery, LTD.

FDA Devices Moderate Nov 21, 2018

Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac str…

Stryker Sustainability Solutions

FDA Devices Moderate Nov 21, 2018

OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G

AROA Biosurgery, LTD.

FDA Devices Moderate Nov 21, 2018

Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provid…

Zimmer Biomet, Inc.

FDA Devices Moderate Nov 21, 2018

Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses …

Johnson & Johnson Surgical Vision Inc

NHTSA Critical Nov 21, 2018

INTERNATIONAL 2018-2019: POWER TRAIN:CLUTCH ASSEMBLY

INTERNATIONAL

CPSC Moderate Nov 20, 2018

HoMedics Recalls Nightlights Due to Choking Hazard (Recall Alert)

G & Y Company Limited, of Hong Kong

CPSC Moderate Nov 20, 2018

Seabreeze International Recalls Bathroom Heaters Due to Fire Hazard

Suzhou Primetech Electronics Co., of JiangSu, China

NHTSA Critical Nov 19, 2018

AUDI 2007-2012: FUEL SYSTEM, GASOLINE:DELIVERY:FUEL PUMP

AUDI

NHTSA Critical Nov 16, 2018

HONDA 2017-2018: EQUIPMENT:OTHER:OWNERS/SERVICE/OTHER MANUAL

HONDA

NHTSA Critical Nov 16, 2018

KENWORTH,PETERBILT 2013-2019: EXTERIOR LIGHTING

KENWORTH,PETERBILT

CPSC Moderate Nov 15, 2018

LÍLLÉbaby Recalls Baby Carriers Due to Fall Hazard (Recall Alert)

CPSC Moderate Nov 15, 2018

RH Recalls Metal-Wrapped Coffee Tables Due to Risk of Lead Exposure (Recall Alert)

Heritage Creations, of Gurgaon, India

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