PlainRecalls

2018 Recalls

7,717 recalls · Page 93 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 11 critical, 38 moderate, and 1 lower-severity recalls. The page references 19 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

Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504

Datascope Corporation

FDA Devices Moderate May 16, 2018

Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874

Datascope Corporation

FDA Devices Moderate May 16, 2018

ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, Ig…

Hyphen BioMed

FDA Devices Critical May 16, 2018

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

Vyaire Medical

FDA Devices Moderate May 16, 2018

ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604

Datascope Corporation

FDA Devices Moderate May 16, 2018

Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113

Straumann Manufacturing, Inc.

FDA Devices Moderate May 16, 2018

POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362

Bard Peripheral Vascular Inc

FDA Devices Moderate May 16, 2018

BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966

Datascope Corporation

FDA Devices Moderate May 16, 2018

PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.

Vygon U.S.A.

FDA Devices Moderate May 16, 2018

Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.

Vygon U.S.A.

FDA Devices Moderate May 16, 2018

Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-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

BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01

Datascope Corporation

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve Product Usage: The AirLife Resuscitation devices are manu…

Vyaire Medical

FDA Devices Moderate May 16, 2018

ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Pro…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

BEQ-TOP 22701, Catalog No. 701050790

Datascope Corporation

FDA Devices Moderate May 16, 2018

Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.

Boston Scientific Corporation

FDA Devices Critical May 16, 2018

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

Vyaire Medical

FDA Devices Moderate May 16, 2018

BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368

Datascope Corporation

FDA Devices Moderate May 16, 2018

Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE Product Usage: The Baxter Sigma Spectrum Infusion Pump with m…

Baxter Healthcare Corporation

FDA Devices Moderate May 16, 2018

BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434

Datascope Corporation

FDA Devices Critical May 16, 2018

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

Vyaire Medical

FDA Devices Moderate May 16, 2018

BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold…

Bard Brachytherapy, Inc.

FDA Devices Moderate May 16, 2018

BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01

Datascope Corporation

FDA Devices Moderate May 16, 2018

Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Replacement kit for outer shell, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation device…

Vyaire Medical

FDA Devices Moderate May 16, 2018

Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-3050, 800-…

Beckman Coulter Inc.

FDA Devices Moderate May 16, 2018

POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP…

Bard Peripheral Vascular Inc

FDA Devices Critical May 16, 2018

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

Vyaire Medical

FDA Devices Moderate May 16, 2018

NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01

Datascope Corporation

FDA Devices Moderate May 16, 2018

MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.

Diagnostic Hybrids, Inc.

FDA Devices Moderate May 16, 2018

Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630

Synthes (USA) Products LLC

FDA Devices Critical May 16, 2018

Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are inhalation anesthesia machines for use in operating, i…

Draeger Medical, Inc.

FDA Devices Moderate May 16, 2018

Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with mas…

Baxter Healthcare Corporation

FDA Devices Moderate May 16, 2018

Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 16, 2018

BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486

Datascope Corporation

FDA Devices Critical May 16, 2018

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

Vyaire Medical

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer, pressure-relief valve, PEEP valve Product Usage: The AirLife Resusc…

Vyaire Medical

FDA Devices Moderate May 16, 2018

AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of v…

Tornier, Inc

FDA Devices Moderate May 16, 2018

Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 16, 2018

BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867

Datascope Corporation

FDA Devices Moderate May 16, 2018

Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reserv…

Cook Inc.

FDA Devices Low May 16, 2018

Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (…

Michigan Instruments, Inc.

FDA Devices Moderate May 16, 2018

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

TP Orthodontics, Inc.

FDA Devices Moderate May 16, 2018

BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253

Datascope Corporation

FDA Devices Critical May 16, 2018

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

Vyaire Medical

FDA Devices Moderate May 16, 2018

Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.

Vygon U.S.A.

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector Product Usage: The AirLife Resuscitation devices are manual resuscita…

Vyaire Medical

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