PlainRecalls

2018 Recalls

7,795 recalls · Page 55 of 156

2018 Recall Year Insight

Federal agencies issued 7,795 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.66% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 21.4 recalls per day across the FDA, CPSC, 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 156 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, 46 moderate, and 2 lower-severity recalls. The page references 26 distinct recalling firms operating in 3 distinct product categories, with 47 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (46), CPSC (2), NHTSA (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, 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 22, 2018

191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave Manifold w/2 Red Rings, Check Valve, 2 MicroClave Clear, Clamp, Rotatin…

ICU Medical de Mexico, S.A. de C.V.

FDA Devices Low Aug 22, 2018

Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs…

Tosoh Bioscience Inc

FDA Devices Moderate Aug 22, 2018

20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic device which p…

ICU Medical de Mexico, S.A. de C.V.

FDA Devices Moderate Aug 22, 2018

TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40,OXY20, THC2S) Product Usage: T-Cube¿ One Ste…

Guangzhou Wondfo Biotech Co., Ltd.

FDA Devices Moderate Aug 22, 2018

Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator

Sorin CRM SAS

FDA Devices Moderate Aug 22, 2018

10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer.

ICU Medical de Mexico, S.A. de C.V.

FDA Devices Moderate Aug 22, 2018

10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer

ICU Medical de Mexico, S.A. de C.V.

FDA Devices Moderate Aug 22, 2018

DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Val…

ICU Medical de Mexico, S.A. de C.V.

FDA Devices Moderate Aug 22, 2018

165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device whi…

ICU Medical de Mexico, S.A. de C.V.

FDA Devices Moderate Aug 22, 2018

18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer.

ICU Medical de Mexico, S.A. de C.V.

FDA Devices Moderate Aug 22, 2018

Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (PD) the…

Merit Medical Systems, Inc.

FDA Devices Moderate Aug 22, 2018

CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the…

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Aug 22, 2018

HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-…

Arrow International Inc

FDA Devices Moderate Aug 22, 2018

AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasiv…

ConvaTec, Inc

FDA Devices Moderate Aug 22, 2018

Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear

ICU Medical de Mexico, S.A. de C.V.

FDA Devices Low Aug 22, 2018

EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for single use with the Therm…

Richard-Allan Scientific Company

FDA Devices Moderate Aug 22, 2018

216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, MicroClave Clear, Clamp, Rotating Luer.

ICU Medical de Mexico, S.A. de C.V.

FDA Devices Moderate Aug 22, 2018

Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults, pedi…

Hamilton Medical AG

FDA Devices Moderate Aug 22, 2018

61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, B…

ICU Medical de Mexico, S.A. de C.V.

FDA Devices Moderate Aug 22, 2018

ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem

Zimmer Biomet, Inc.

FDA Devices Moderate Aug 22, 2018

Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product…

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Aug 22, 2018

The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.

Intuitive Surgical, Inc.

FDA Devices Moderate Aug 22, 2018

43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.

ICU Medical de Mexico, S.A. de C.V.

FDA Devices Moderate Aug 22, 2018

10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave (Light Blue Ring), Check Valve, Clamp, …

ICU Medical de Mexico, S.A. de C.V.

FDA Devices Moderate Aug 22, 2018

Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and …

Hamilton Medical AG

FDA Devices Moderate Aug 22, 2018

ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: Artis is a family of dedicated angiography systems developed …

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Aug 22, 2018

Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator

Sorin CRM SAS

FDA Devices Moderate Aug 22, 2018

30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which…

ICU Medical de Mexico, S.A. de C.V.

FDA Devices Moderate Aug 22, 2018

TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube¿ One S…

Guangzhou Wondfo Biotech Co., Ltd.

FDA Devices Moderate Aug 22, 2018

Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists of a silicone band with pillows that are filled wi…

Apollo Endosurgery Inc

FDA Devices Moderate Aug 22, 2018

TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube¿ One Step Multi-Drug Oral Fluid Test …

Guangzhou Wondfo Biotech Co., Ltd.

FDA Devices Moderate Aug 22, 2018

PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer.

ICU Medical de Mexico, S.A. de C.V.

FDA Devices Moderate Aug 22, 2018

Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product Usage: Medical exam glove for use by professional healthcare workers and/or consu…

Cypress Medical Products LLC

FDA Devices Moderate Aug 22, 2018

Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of d…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Aug 22, 2018

Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set are single-use, sterile, wi…

Guangzhou Improve Medical Instruments Co., Ltd.

FDA Devices Moderate Aug 22, 2018

G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 …

Tosoh Bioscience Inc

FDA Devices Moderate Aug 22, 2018

O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.

Beekley Corporation

FDA Devices Moderate Aug 22, 2018

Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.

DRG Instruments GmbH

FDA Devices Moderate Aug 22, 2018

Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive

Withings Sas

FDA Devices Moderate Aug 22, 2018

11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.

ICU Medical de Mexico, S.A. de C.V.

FDA Devices Moderate Aug 22, 2018

VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been …

Cook Inc.

FDA Devices Moderate Aug 22, 2018

NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessory to t…

NxStage Medical, Inc.

FDA Devices Moderate Aug 22, 2018

28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer.

ICU Medical de Mexico, S.A. de C.V.

FDA Devices Moderate Aug 22, 2018

Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive…

Mako Surgical Corporation

FDA Devices Moderate Aug 22, 2018

6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.

ICU Medical de Mexico, S.A. de C.V.

FDA Devices Moderate Aug 22, 2018

MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715

Megadyne Medical Products, Inc.

CPSC Moderate Aug 22, 2018

Vornado Air Reannounces Recall of Electric Space Heaters Following Report of Death; Fire and Burn Hazards

CPSC Moderate Aug 22, 2018

Yamaha Recalls Snowmobiles Due to Injury Hazard (Recall Alert)

Yamaha Motor Corporation U.S.A., of Cypress, Calif.

NHTSA Critical Aug 22, 2018

KENWORTH 2016-2018: ENGINE AND ENGINE COOLING:ENGINE:DIESEL

KENWORTH

NHTSA Critical Aug 22, 2018

VOLVO 2019: SERVICE BRAKES, HYDRAULIC:PEDALS AND LINKAGES

VOLVO

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 - consumer product and vehicle recall feeds for 2018

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Figures cover calendar year 2018 across the FDA, CPSC 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 July 2026.