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 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, 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 Jun 20, 2018

RS 5F DL BIOFLO PASV, Catalog Number 60M132324

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents. Fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens

BioMerieux SA

FDA Devices Moderate Jun 20, 2018

Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

Keystone Dental Inc

FDA Devices Moderate Jun 20, 2018

The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK¿ 2 Systems for the automated identification of most clinically significant anaerobic organisms and Corynebatcerium species. The VITEK¿ 2 ANC identification card is a single-use disposable. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and p

BioMerieux SA

FDA Devices Moderate Jun 20, 2018

BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

RS TANDEM 5F DL XPP, Catalog Number 60M019881

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

Part #: SAM XT-M, Model: Tactical Black or Military

The Seaberg Company Inc

FDA Devices Moderate Jun 20, 2018

Proteus ONE and Proteus Plus

Ion Beam Applications S.A.

FDA Devices Moderate Jun 20, 2018

Part #: SAM XT-C, Model: Hi-Viz Blue

The Seaberg Company Inc

FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126FP

Sun Med, LLC

FDA Devices Moderate Jun 20, 2018

Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 20, 2018

IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352

Philips Electronics North America Corporation

FDA Devices Moderate Jun 20, 2018

5F DL BIOFLO PICC, Catalog Number 60M180592

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to s

Datascope Corporation

FDA Devices Moderate Jun 20, 2018

BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG, Catalog Number 75-032

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for u

Datascope Corporation

FDA Devices Moderate Jun 20, 2018

Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Jun 20, 2018

remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).

Thermo Fisher

FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116P

Sun Med, LLC

FDA Devices Moderate Jun 20, 2018

IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350

Philips Electronics North America Corporation

FDA Devices Moderate Jun 20, 2018

Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126F

Sun Med, LLC

FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1116

Sun Med, LLC

FDA Devices Moderate Jun 20, 2018

CAN 5F DUAL XCELA PICC, Catalog Number 60M701532

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116PC

Sun Med, LLC

FDA Devices Moderate Jun 20, 2018

Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and 17312BB.

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Jun 20, 2018

RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity in human serum or plasma (lithium heparin, sodium citrate, EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasma gondii in serum. Additionally, some of these reagents consist of anti

BioMerieux SA

FDA Devices Moderate Jun 20, 2018

RS 5F DL BIOFLO PASV, Catalog Number 60M150373

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total Knee Arthroplasty

Zimmer Biomet, Inc.

FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1116F

Sun Med, LLC

FDA Devices Moderate Jun 20, 2018

Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population.

Shimadzu Medical Systems

FDA Devices Moderate Jun 20, 2018

Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass

Maquet Cardiopulmonary Ag

FDA Devices Moderate Jun 20, 2018

CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition

Cellavision AB

FDA Devices Moderate Jun 20, 2018

Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up t

Datascope Corporation

FDA Devices Moderate Jun 20, 2018

Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypass

Maquet Cardiopulmonary Ag

FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1126

Sun Med, LLC

FDA Devices Moderate Jun 20, 2018

Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes. Laser scanning microscopes are used in cell biology research.

Zeiss, Carl Inc

FDA Devices Moderate Jun 20, 2018

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK 5, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116PD5

Sun Med, LLC

FDA Devices Moderate Jun 20, 2018

RS 5F DL BIOFLO PASV, Catalog Number 60M181578

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

RS 5F DL BIOFLO PICC, Catalog Number 60M071831

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

DermaPro Waterproof Silicone Tape, SNS57232

Safe N Simple, LLC

FDA Devices Moderate Jun 20, 2018

smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)

Smith & Nephew, Inc.

FDA Devices Moderate Jun 20, 2018

Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek Performa test strips are for use with the Accu-Chek Performa meter to quantitatively measure glucose (sugar) in venous whole blood or fresh capillary whole blood samples from the fingertips.

Roche Diabetes Care, Inc.

FDA Devices Moderate Jun 20, 2018

The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most significant Gram-positive organisms. The VITEK 2 GP identification card Is a single-use disposable. GP TEST KIT VTK2 20 CARTES A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips

BioMerieux SA

FDA Devices Moderate Jun 20, 2018

Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 20, 2018

XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124

Angiodynamics Inc. (Navilyst Medical Inc.)

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.