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 0 critical, 50 moderate, and 0 lower-severity recalls. The page references 9 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 Aug 15, 2018

Radio Capitellum, Recon Head, Size #2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

135" (343 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical, Inc.

FDA Devices Moderate Aug 15, 2018

rHead Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

radial head implant #4 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

rHead Recon Stem Implant non-coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

Lateral Assembly, Radial Head Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

rHead Stem Implant 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

Lateral Assembly, Radial Stem Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

rHead Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

rHead Standard Extended Stem, 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

radial head implant #3 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Export For PTZ Video Ext. Video cart used for mobile medical record documentation.

Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

FDA Devices Moderate Aug 15, 2018

radial stem implant #4 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

rHead Recon Stem Implant non-coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above.

Datex-Ohmeda, Inc.

FDA Devices Moderate Aug 15, 2018

99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical, Inc.

FDA Devices Moderate Aug 15, 2018

Lat Assembly, Rad Stem Implant,Collar 6mm, Size1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

Radial Head Assy Size #3, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

Radial Head Assy Size #2, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.

Water Pik, Inc.

FDA Devices Moderate Aug 15, 2018

108" 20 Drop Blood Set w/200 Micron Filter, Remv 3-Way Stopcock w/MicroClave¿, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical, Inc.

FDA Devices Moderate Aug 15, 2018

Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07

New Era Orthopaedics, LLc

FDA Devices Moderate Aug 15, 2018

rHead Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

Quick Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient lifters to measure the weight of a patient who cannot stand on a scale. It is designed to be used indoors in hospitals, nursing homes, home care or health care facilities.

Arjohuntleigh Magog

FDA Devices Moderate Aug 15, 2018

radial head implant #2 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

185 cm (73") Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical, Inc.

FDA Devices Moderate Aug 15, 2018

Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classification: The INOmeter is an accessory to the nitric oxide delivery device which is used for the delivery of inhaled nitric oxide to patient. An INOmeter is affixed to each cylinder of drug product. Functionality of the INOmeter: The INOmeter is affixed on top of each INOflo cylinder valve in Japan. When the healthcare provider opens the INOmeter the compressed gas cylinder valve opens to begin flo

INO therapeutics LLC/dba ikaria

FDA Devices Moderate Aug 15, 2018

Lat Assembly, Rad Stem Implant,Collar 6mm,Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

85" (216 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical, Inc.

FDA Devices Moderate Aug 15, 2018

80" (203 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical, Inc.

FDA Devices Moderate Aug 15, 2018

84" (213 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Cylindrical Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical, Inc.

FDA Devices Moderate Aug 15, 2018

Lateral Assembly, Radial Stem Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

Lateral Assembly, Radial Stem Implant, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

137" (348 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 3 Gang 4-Way Stopcock, Luer Lock, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical, Inc.

FDA Devices Moderate Aug 15, 2018

rHead Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

radial stem implant #2 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

175" (445 cm) Y-Type Blood Set w/170 Micron Blood Filter, Hand Pump, Inj Site, Remv 3 Gang 4-Way Stopcocks w/Baseplate, 2 Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical, Inc.

FDA Devices Moderate Aug 15, 2018

VitalGo Total Lift Bed VG-TLB425T-TQR, Version 71064V0-27003

Vitalgo Inc.

FDA Devices Moderate Aug 15, 2018

rHead Recon Extended Stem Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

rHead Recon Stem Implant 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

125" (318 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 4 MicroClave¿ Clear, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical, Inc.

FDA Devices Moderate Aug 15, 2018

98" (249 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4-Way Stopcocks, Luer Lock, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical, Inc.

FDA Devices Moderate Aug 15, 2018

84" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical, Inc.

FDA Devices Moderate Aug 15, 2018

128" (325 cm) Y-Type Blood Set with 170 Micron Filter, Hand Pump, 2 Clave¿, Removable 2 Gang (Blue, Yellow) 1o2¿ Manifold, Baseplate, 1 Ext, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical, Inc.

FDA Devices Moderate Aug 15, 2018

rHead Stem Implant Plasma Coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 15, 2018

32" (81 cm) Appx 4.4 mL, 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical, Inc.

FDA Devices Moderate Aug 15, 2018

120" (305cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical, Inc.

FDA Devices Moderate Aug 15, 2018

100" (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical, Inc.

FDA Devices Moderate Aug 15, 2018

Lat Assembly, Rad Stem Implant,Collar 6mm,Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics Corp.

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.