PlainRecalls

2018 Recalls

7,717 recalls · Page 95 of 155

2018 Recall Year Insight

Federal agencies issued 7,717 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 9.19% of the 83,949 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 9 critical, 39 moderate, and 2 lower-severity recalls. The page references 16 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 May 16, 2018

Jasper Vektor, Class II Correction Appliance, Part No. 610-527L used for correcting class 2 malocclusions by applying light forces on the teeth using…

TP Orthodontics, Inc.

FDA Devices Moderate May 16, 2018

PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.

Boston Scientific Corporation

FDA Devices Moderate May 16, 2018

Jasper Vektor, Class II Correction Appliance, Part No. 610-530R used for correcting class 2 malocclusions by applying light forces on the teeth using…

TP Orthodontics, Inc.

FDA Devices Moderate May 16, 2018

Uphold Vaginal Support System; Model #M0068317080. Indicated for tissue reinforcement in women with pelvic organ prolapse.

Boston Scientific Corporation

FDA Devices Moderate May 16, 2018

Jasper Vektor, Class II Correction Appliance, Part No. 610-533R used for correcting class 2 malocclusions by applying light forces on the teeth using…

TP Orthodontics, Inc.

FDA Devices Moderate May 16, 2018

POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP0…

Bard Peripheral Vascular Inc

FDA Devices Moderate May 16, 2018

ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the global detection of heparin- dependent ant…

Hyphen BioMed

FDA Devices Moderate May 16, 2018

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi 3g Allergy specific IgE Universal Kit

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

Jasper Vektor, Class II Correction Appliance, Part No. 610-530L used for correcting class 2 malocclusions by applying light forces on the teeth using…

TP Orthodontics, Inc.

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, PEEP valve Product Usage: The AirLife Resuscitation devices are manual r…

Vyaire Medical

FDA Devices Moderate May 16, 2018

Connecting Tube - Female to Male Luer Lock, HPCT8.8-30-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reserv…

Cook Inc.

FDA Devices Moderate May 16, 2018

Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fix…

Zimmer Biomet, Inc.

FDA Devices Moderate May 16, 2018

ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of…

Hyphen BioMed

FDA Devices Moderate May 16, 2018

Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge

Siemens Healthcare Diagnostics, Inc.

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer Product Usage: The Air…

Vyaire Medical

FDA Devices Moderate May 16, 2018

Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reserv…

Cook Inc.

FDA Devices Moderate May 16, 2018

POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362

Bard Peripheral Vascular Inc

FDA Devices Moderate May 16, 2018

Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-00…

ICU Medical, Inc.

FDA Devices Moderate May 16, 2018

Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143/10635565) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Pediatric, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are…

Vyaire Medical

FDA Devices Moderate May 16, 2018

Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattachment procedures in the ankle/foot and knee.

Zimmer Biomet, Inc.

FDA Devices Moderate May 16, 2018

Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system.

Vygon U.S.A.

FDA Devices Moderate May 16, 2018

Jasper Vektor, Class II Correction Appliance, Part No. 610-536 used for correcting class 2 malocclusions by applying light forces on the teeth using …

TP Orthodontics, Inc.

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitat…

Vyaire Medical

FDA Devices Moderate May 16, 2018

ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroep…

Abbott Gmbh & Co. KG

FDA Devices Moderate May 16, 2018

IMMULITE 2000/IMMULITE ¿ 2000 XPi OM-MA (CA125)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the ankle/foot and knee.

Zimmer Biomet, Inc.

FDA Devices Moderate May 16, 2018

Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115

Straumann Manufacturing, Inc.

FDA Devices Moderate May 16, 2018

CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Cardiohelp Gas Bottle (or Cylinder) Holder HKH 8880…

Maquet Cardiopulmonary Ag

FDA Devices Moderate May 16, 2018

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi TG

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115 The ReNew single patient use disposable tips are to be used with t…

Microline Surgical, Inc.

FDA Devices Moderate May 16, 2018

Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse.

Boston Scientific Corporation

FDA Devices Moderate May 16, 2018

Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse.

Boston Scientific Corporation

FDA Devices Moderate May 16, 2018

POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301

Bard Peripheral Vascular Inc

FDA Devices Moderate May 16, 2018

Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattachment procedures in the ankle/foot and knee.

Zimmer Biomet, Inc.

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve Product Usage: The AirLife Resuscitation devices are man…

Vyaire Medical

FDA Devices Moderate May 16, 2018

Jasper Vektor, Class II Correction Appliance, Part No. 610-500 used for correcting class 2 malocclusions by applying light forces on the teeth using …

TP Orthodontics, Inc.

FDA Devices Moderate May 16, 2018

Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge

Siemens Healthcare Diagnostics, Inc.

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devic…

Vyaire Medical

FDA Devices Moderate May 16, 2018

Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in general suturing applications during open or endoscopic surgery to assis…

Boston Scientific Corporation

FDA Devices Low May 16, 2018

Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

IMMULITE ¿ /IMMULITE ¿ 1000 TG

Siemens Healthcare Diagnostics, Inc.

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitati…

Vyaire Medical

FDA Devices Critical May 16, 2018

Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The products are inhalation anesthesia machines for use in operating, induc…

Draeger Medical, Inc.

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer Product Usage: The AirLife Resuscitati…

Vyaire Medical

FDA Devices Moderate May 16, 2018

BEQ-TOP 50903 Custom ECC Pack-Pedriatric , Custom Tubing Kit, Catalog No. 709000078

Datascope Corporation

FDA Devices Moderate May 16, 2018

Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475530) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Low May 16, 2018

Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

BEQ-TOP 33500 3/8" ECC PACK, Catalog No. 701053752

Datascope 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