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, 46 moderate, and 1 lower-severity recalls. The page references 16 distinct recalling firms operating in 3 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (46), FDA Drug (3), FDA Food (1), 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 Food Moderate Jun 6, 2018

The Most Awesome Chocolate Bar EVER, packaged individually in a 1.5 oz bar. The UPC is 8 55966 00178 9. The label is read in parts: "***Lillie Belle Farms***The Most Awesome Chocolate Bar EVER! ***Ingredients: organic milk and dark chocolate (organic cocoa mass, organic cocoa liquor, organic sugar, organic vanilla, organic milk powder, non-gmo soy lecithin, organic sunflower lecithin), organic sugar, almonds, hazelnuts, salt flour***".

JJBL LLC

FDA Drug Critical Jun 6, 2018

7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148

Shoreside Enterprises Inc.

FDA Drug Critical Jun 6, 2018

POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, UPC 638632428857

Shoreside Enterprises Inc.

FDA Drug Low Jun 6, 2018

Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020 NDC 43386-356-10 UPC 343386356102

LUPIN SOMERSET

FDA Devices Moderate Jun 6, 2018

4Fr. Catheter Clamp with Fastener; Product Code: CC-00004

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

8Fr. Catheter Clamp with Fastener; Product Code: CC-00008

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Maximal Barrier Drape; Product Code: ASK-04000-HMC

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters ; Product Codes: ASK-09903-UM

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC40A Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.

Medline Industries Inc

FDA Devices Moderate Jun 6, 2018

ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features (Recommended for use with 7 Fr. Catheters); Product Code: ASK-09907-SB

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Peel Away Sheath over Dilator; Product Codes: PL-05041 and PL-05052

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715, Model Number 5227 A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.

Dynarex Corporation

FDA Devices Moderate Jun 6, 2018

Maximal Barrier Drape; Product Codes: ASK-00001-1A

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-PTJH and ASK-45703-PTJH

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703-P1A

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx, sterile, Rx only. Labeled as: a. Product Code LX-12; b. Product Code LX-13; c. Product Code LX-14; d. Product Code LX-15; e. Product Code LX-16; f. Product Code LX-17; Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppres

Torax Medical, Inc.

FDA Devices Moderate Jun 6, 2018

Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product code: ASK-45703-AEH

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument Connector, 12' (3.6m), REF 87500, QTY 50 (b) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102, QTY 10 (c) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102SPC, QTY 10 (d) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1103, QTY 50 (e) Bipolar Cord, Twin Pin Connector, Angled 45o, 12' (3.6m), REF 40-1104, QTY 10 (f) Bipolar Cord, 28 mm Fixed Pin Connector, REF 40-1105-28, QTY 10

Olsen Medical

FDA Devices Moderate Jun 6, 2018

nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.

NordicNeuroLab AS

FDA Devices Moderate Jun 6, 2018

Epidural Needle; Product Codes: AN-05501 and AN-05505

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJ

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Radial Arterial Access Kit; Product Code: ASK-04001-BID2

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a sterile state and are single-use only. Used to drill cranial holes using a stereotactic frame.

Ad-Tech Medical Instrument Corporation

FDA Devices Moderate Jun 6, 2018

Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit; Product Code: ASK-42802-PWHC1

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Arterial Catheterization Kit; Product Code:NA-04550-1A

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Extension Line Slide Clamps; Product codes: SA-09847

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42802-DMC

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic struc

Ethicon Endo-Surgery Inc

FDA Devices Critical Jun 6, 2018

CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179

Maquet Datascope Corp - Cardiac Assist Division

FDA Devices Moderate Jun 6, 2018

Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Respire Pink Series EF+ Oral Sleep Apnea Device.

Respire Medical

FDA Devices Moderate Jun 6, 2018

MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold Standard/Standard Or/Oro y Estander, 40 Ct. Foam Block / Magnet with Blade Remover, Coussinet en mousse pour 40 aiguilles /Magnetise avec quitte-lame Or, 40 Ct Bloque de espuma / Iman Con extractor de hoja - Oro, REF NC40FBRGS Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in

Medline Industries Inc

FDA Devices Moderate Jun 6, 2018

Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50 (b) Button Switchpen, w/ Standard Blade Electrode, REF 75530, QTY 50 (c) Rocker Switchpen, w/ Standard Blade Electrode, REF 75610, QTY 50 (d) Button Switchpen, w/ Extendable Blade Electrode, 10 mm Exposure, REF 75800, QTY 25 (e) Button Switchpen, w/ Extendable Blade Electrode, 2 mm Exposure, REF 75810, QTY 25 (f) Button Switchpen, w/ Extendable Needle Electrode, 2 mm Exposure, REF 75820, Q

Olsen Medical

FDA Devices Moderate Jun 6, 2018

ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: ASK-45703-VC

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-RV1

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-09903-UPA

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Respire Pink H/S Oral Sleep Apnea Device

Respire Medical

FDA Devices Moderate Jun 6, 2018

SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Jun 6, 2018

PICC Catheter Trimmer ; Product Code:PC-00001-T

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM, PR-35052-HPHNM, PR-35541-HPHNL, PR-35541-HPHNM, PR-35552-HPHNL, PR-35552-HPHNM

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

VPS Rhythm ECG Accessory Pack ; Product codes: RHY-100-ECGO

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.

Medline Industries Inc

FDA Devices Moderate Jun 6, 2018

TheraCath(R) Epidural Catheter; Product Code: EC-05000

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

7Fr. Catheter Clamp with Fastener; Product Code: CC-00007

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of the system are : Scalable purification of 1 to 24 samples Primary/secondary tube handling Inventory and sample management via barcodes Efficient order management via host The MagNA Pure 24 System offers 4 run types:

Roche Molecular Systems, Inc.

FDA Devices Moderate Jun 6, 2018

Maximal Barrier Drape; Product Codes: ASK-00002-1A

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVID266 Sterile This OR towel product is intended for external use only. These towels are intended to be used as absorbent towels for hand drying, cleanup, and to provide increased absorbency of blood and bodily fluids. There are no instruction catalogues or manuals included with the product as these are intended to be used in accordance with hospital protocol.

Medical Action Industries Inc

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.