PlainRecalls

2018 Recalls

Compiled from official public sources by the editorial team.

7,717 recalls · Page 118 of 155

2018 Recall Year Insight

Federal agencies issued 7,717 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.70% of the 100,165 total recalls we track from 1995 through the present, and averages roughly 21.1 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 155 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, 47 moderate, and 0 lower-severity recalls. The page references 20 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, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate Mar 28, 2018

CATHETER SECUREMENT SYSTEM

Centurion Medical Products Corporation

FDA Devices Critical Mar 28, 2018

BD Vacutainer¿ Lithium Heparin Green Top Tube; Catalog Numbers: 1. 366664 (UDI: 50382903666640); 2. 367884 (UDI: 50382903678841); 3. 367886 (UDI: 503…

Becton Dickinson & Company

FDA Devices Moderate Mar 28, 2018

NEONATAL IV START KIT

Centurion Medical Products Corporation

FDA Devices Moderate Mar 28, 2018

SwishPlus Implant Intended for use in support for fixed bridgework.

Implant Direct Sybron Manufacturing, LLC

FDA Devices Moderate Mar 28, 2018

IV START KIT

Centurion Medical Products Corporation

FDA Devices Moderate Mar 28, 2018

Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 …

Arrow International Inc

FDA Devices Moderate Mar 28, 2018

Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with Medica…

Medica Corporation

FDA Devices Moderate Mar 28, 2018

12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 Product Usage: The Medcomp Repair Kit is indicated for use in repla…

Medical Components, Inc dba MedComp

FDA Devices Moderate Mar 28, 2018

INFANT IV SECUREMENT KIT

Centurion Medical Products Corporation

FDA Devices Critical Mar 28, 2018

BD Vacutainer¿ EDTA Pink Top Tube; Catalog Numbers: 1. 367842 (UDI: 50382903678421); 2. 367899 (UDI: 50382903678995); 3. 368049 (UDI: 50382903680493)…

Becton Dickinson & Company

FDA Devices Moderate Mar 28, 2018

ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion of physician…

Vascular Insights, LLC

FDA Devices Moderate Mar 28, 2018

Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfat…

Epigenomics Ag

FDA Devices Moderate Mar 28, 2018

REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, c…

Medical Components, Inc dba MedComp

FDA Devices Moderate Mar 28, 2018

CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her co…

Medical Components, Inc dba MedComp

FDA Devices Moderate Mar 28, 2018

Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interventional pro…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Mar 28, 2018

J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N

Bovie Medical Corporation

FDA Devices Moderate Mar 28, 2018

DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold closed easily ap…

Ethicon, Inc.

FDA Devices Moderate Mar 28, 2018

Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a primary or revision total knee…

OMNIlife science Inc.

FDA Devices Moderate Mar 28, 2018

MINI PLASTICS SET

Centurion Medical Products Corporation

FDA Devices Moderate Mar 28, 2018

J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF

Bovie Medical Corporation

FDA Devices Moderate Mar 28, 2018

AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and so…

Beckman Coulter Inc.

FDA Devices Moderate Mar 28, 2018

U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indicated in knee…

United Orthopedic Corporation

FDA Devices Moderate Mar 28, 2018

TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her conn…

Medical Components, Inc dba MedComp

FDA Devices Moderate Mar 28, 2018

Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot Nephrostomy Catheter Set is intended to…

Boston Scientific Corporation

FDA Devices Moderate Mar 28, 2018

Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use cotton disposable that must be used…

Covidien LLC

FDA Devices Moderate Mar 28, 2018

AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated angiography systems develope…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Mar 28, 2018

SorbaView Shield Dressing Change Tray

Centurion Medical Products Corporation

FDA Devices Moderate Mar 28, 2018

SwishTapered Implant Intended for use in support for fixed bridgework.

Implant Direct Sybron Manufacturing, LLC

FDA Devices Moderate Mar 28, 2018

J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B

Bovie Medical Corporation

FDA Devices Moderate Mar 28, 2018

Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter Set is intended to establish…

Boston Scientific Corporation

FDA Devices Critical Mar 28, 2018

BD Vacutainer¿ EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551)

Becton Dickinson & Company

FDA Devices Moderate Mar 28, 2018

SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600

Boston Scientific Corporation

FDA Devices Moderate Mar 28, 2018

U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthroplasty for …

United Orthopedic Corporation

FDA Devices Moderate Mar 28, 2018

MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA52…

ESAOTE S.P.A.

FDA Devices Moderate Mar 28, 2018

Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiri…

Smiths Medical ASD Inc.

FDA Devices Moderate Mar 28, 2018

NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One

NxStage Medical, Inc.

FDA Devices Moderate Mar 28, 2018

BLOOD DRAW KIT

Centurion Medical Products Corporation

FDA Devices Moderate Mar 28, 2018

CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her …

Medical Components, Inc dba MedComp

FDA Devices Moderate Mar 28, 2018

Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting Malecot Catheters are designed…

Boston Scientific Corporation

FDA Devices Moderate Mar 28, 2018

MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10

ESAOTE S.P.A.

FDA Devices Moderate Mar 28, 2018

MINOR DRESSING CHANGE TRAY

Centurion Medical Products Corporation

FDA Devices Moderate Mar 28, 2018

REPAIR KIT, REF ARA101, UDI 884908083637 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, cla…

Medical Components, Inc dba MedComp

FDA Devices Moderate Mar 28, 2018

EXCISION TRAY

Centurion Medical Products Corporation

FDA Devices Moderate Mar 28, 2018

Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Prec…

Arrow International Inc

FDA Devices Moderate Mar 28, 2018

WOUND CARE KIT

Centurion Medical Products Corporation

FDA Devices Moderate Mar 28, 2018

GENICON EZEE Retrieval, sterile, Rx only.

Genicon, Inc.

FDA Devices Moderate Mar 28, 2018

INCISION & DRAINAGE TRAY or KIT

Centurion Medical Products Corporation

FDA Devices Moderate Mar 28, 2018

AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number …

Beckman Coulter Inc.

FDA Devices Moderate Mar 28, 2018

TUBING CHANGE KIT

Centurion Medical Products Corporation

FDA Devices Moderate Mar 28, 2018

J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS

Bovie Medical Corporation

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