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 1 critical, 49 moderate, and 0 lower-severity recalls. The page references 13 distinct recalling firms operating in 1 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (50), 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 Jun 6, 2018

Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Codes: ASK-04301-TJ

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

5Fr. Catheter Clamp with Fastener; Product Code: CC-00005

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNM

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr. Catheters; Product Code: ASK-21142-WHC2

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

SOMATOM go.Now, Material Number 11061618 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

LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: a. Product Code LXC-12; b. Product Code LXC-13; c. Product Code LXC-14; d. Product Code LXC-15; e. Product Code LXC-16; f. Product Code LXC-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

Torax Medical, Inc.

FDA Devices Moderate Jun 6, 2018

Percutaneous Sheath Introducer Kit with ARROWgard Blue¿ Sheath and Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheters; Product Codes: MSO-29802-AHS and MSO-29903-AHS

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 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

LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx only. Labeled as: a. Product Code LS-12; b. Product Code LS-13; c. Product Code LS-14; d. Product Code LS-15; e. Product Code LS-16; f. Product Code LS-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 suppre

Torax Medical, Inc.

FDA Devices Moderate Jun 6, 2018

nordicTumorEx 1.0 nordicTumorEx 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. nordicTumorEx software enables processing and visualization of dynamic MR imaging dataset

NordicNeuroLab AS

FDA Devices Moderate Jun 6, 2018

MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-21242-NYP and ASK-21242-PR

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters; Product Codes: ASK-29803-SJH, ASK-29903-SJH, and ASK-29903-UW1

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.

Siemens Healthcare Diagnostics, Inc.

FDA Devices Critical Jun 6, 2018

Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420 (b) DC Adapter, Product numbers: 1435, 1440 (c) AC Adapter, Product numbers: 1425, 1430 (d) Battery Pack, Product number: 1650DE Indication for Use for OUS HVAD System: The HVAD System is intended for use in patients at risk of death from refractory end-stage heart failure. The HVAD System is designed for in-hospital and out-

Heartware

FDA Devices Moderate Jun 6, 2018

Sheath Adapter with Cath-Gard¿ Catheter Contamination Shield for use with 4 - 7 Fr. Catheters; Product codes: SA-09847

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Arterial Catheterization Kit; Product Codes: ASK-04020-DH

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs that connect to a generator on one end and a plug that connects to a Gyrus ACMI working element on the other end. They are provided non-sterile and are reusable. The cord is designed to be used with Gyrus ACMI GOCUS 640, Bovie, and other general purpose monopolar electrosurgical generators and appropriate electrodes a

Gyrus Acmi, Incorporated

FDA Devices Moderate Jun 6, 2018

ARROWg+ard Blue PLUS¿ Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-42802-P1A

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 Codes: ASK-45703-SCH; ASK-45703-UAB, ASK-45703-VAH

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Echogenic Introducer Needle; Product Code: AN-04318

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

ARROWg+ard Blue¿ PSI Kit with Integral Hemostasis Valve/ Side Port for use with 7 - 7.5 Fr. Catheters; Product codes: SF-29803-1

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Clear Fenestrated Drape with Adhesive; Product Code: CD-00001

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 and Sharps Safety Features; Product Codes: ASK-42703-MHW and ASK-42703-OLL1

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

ARROW PICC Set; Product codes: PR-35563-HPHNL and PR-35563-HPHNM

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BAS, PR-45541-BAS,PR-45541-HPHNL, PR-45541-HPHNM, PR-45552-BAS, PR-45552-HPHNL,PR-45552-HPHNM, PR-45563-BAS, PR-45563-HPHNL, PR-45563-HPHNM

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires; Product Code: AI-07000

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Respire Pink+ Hard/Soft Oral Sleep Apnea Device

Respire Medical

FDA Devices Moderate Jun 6, 2018

ARROWgard Blue PLUS¿ Multi-Lumen CVC Kit with Blue FlexTip¿ Catheter; Product Code: MSO-45703-AHS

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve/Side Port for use with 7 - 8 Fr. Catheters and Arrow Percutaneous Introducer System; Product codes: SS-09903-S

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

0.2 Micron Flat Epidural Filter; Product Code: EF-05500

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT600DF AIM STP; 568821910, VLT600SF STP QL; 568821911, VLT600SF AIM STP QL; 568821960, VLT600DF STP QL; 568821961, VLT600DF AIM STP QL VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or patient during surgical operations, diag

Maquet SAS

FDA Devices Moderate Jun 6, 2018

HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physici

Philips Electronics North America Corporation

FDA Devices Moderate Jun 6, 2018

Symmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" (20.3cm) Serrated Tips, REF 20-2650K, QTY 10 (b) Insulated Bayonet Forceps 8.25" (21.0cm) Serrated 1.5mm Tips, REF 20-2920HK, QTY 10 (c) Insulated Bayonet Forceps 8.5" (21.6cm) Serrated 1.5mm Tips, REF 20-2920K, QTY 10 (d) Insulated Bayonet Forceps 7.5" (19.1cm) 1.5mm Cathedral Tips, REF 20-2960HK, QTY 10

Olsen Medical

FDA Devices Moderate Jun 6, 2018

nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.

NordicNeuroLab AS

FDA Devices Moderate Jun 6, 2018

Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography (RAECG); Product Code: EG-04900

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Maximal Barrier Drape; Product Codes: ASK-00376-SU

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

Symmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR Connector, 10' (3.0m), REF 92002, QTY 50 (b) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2106, QTY 10 (c) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2110, QTY 10 Designed to bring high frequency electrical power from the electrosurgical generator to the active.

Olsen Medical

FDA Devices Moderate Jun 6, 2018

Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.

Genesee BioMedical, Inc.

FDA Devices Moderate Jun 6, 2018

Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42802-VC and ASK-47702-VC

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Echogenic Needle; Product codes: PN-00215-E and PN-00217-E

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Spring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

VPS TipTracker Stylet Accessory; Product codes: RHY-177-TTSAP

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip¿, ARROWg+ard Blue PLUS¿ Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Codes: ASK-45703-LDP1, ASK-45703-PBHS, ASK-45703-PHMC

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-15703-LDP1

Arrow International Inc

FDA Devices Moderate Jun 6, 2018

Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18080-N, AB-18110-N

Arrow International 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.