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 1 critical, 47 moderate, and 2 lower-severity recalls. The page references 26 distinct recalling firms operating in 1 distinct product categories, with 43 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 Apr 4, 2018

Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction

Biomet, Inc.

FDA Devices Moderate Apr 4, 2018

Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System.

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Apr 4, 2018

Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)

Zimmer Biomet, Inc.

FDA Devices Moderate Apr 4, 2018

Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19 UDI: 0735000201006820171130

RAYSEARCH LABORATORIES AB

FDA Devices Moderate Apr 4, 2018

Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for orthopedic use.

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Apr 4, 2018

ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER TROC END CAP 10MM STER TROC END CAP 15MM STER TROC END CAP 20MM STER TROC END CAP 25MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures

Zimmer Biomet, Inc.

FDA Devices Moderate Apr 4, 2018

MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose

ConMed Corporation

FDA Devices Moderate Apr 4, 2018

Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 04560141945470

Konica Minolta Medical Imaging USA, Inc.

FDA Devices Moderate Apr 4, 2018

IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600

Deerfield Imaging, Inc.

FDA Devices Moderate Apr 4, 2018

1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24215; 3. Sydney IVF¿ Embryo Transfer Set, Product Number: K-JETS-7019-SIVF, Global Product Number: G18740

Cook Inc.

FDA Devices Moderate Apr 4, 2018

MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants who

ConMed Corporation

FDA Devices Moderate Apr 4, 2018

Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Apr 4, 2018

Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate attachment and consolidation of patient equipment to one central patient care area. Devices commonly attached to IV poles include IV pumps, feeding pumps, and infusion fluid bags. Products used on: Giraffe OmniBed, Giraffe Warmers, Panda Warmers and Giraffe Incubators and Giraffe Shuttle. The IV pole also can be mounted to the Care Plus Incuba

Ohmeda Medical

FDA Devices Moderate Apr 4, 2018

Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.

Zimmer Dental Inc

FDA Devices Moderate Apr 4, 2018

ACE Trochanteric Nail System STER TROC NAIL 125 DEG X 9MM STER TROC NAIL 130 DEG X 9MM STER TROC NAIL 135 DEG X 9MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fra

Zimmer Biomet, Inc.

FDA Devices Moderate Apr 4, 2018

DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia.

GE Healthcare, LLC

FDA Devices Moderate Apr 4, 2018

1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Apr 4, 2018

Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 2in)

Johnson & Johnson Consumer, Inc.

FDA Devices Moderate Apr 4, 2018

The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a pathway into the pedicle. The instrument has three types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The Pedicle Feeler is laser marked in 10 mm intervals to help indicate the depth in which the feeler tip has been inserted into the pedicle. Next to the navigational information, these depth indicators on the feeler tip are a

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Apr 4, 2018

MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is

ConMed Corporation

FDA Devices Moderate Apr 4, 2018

Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 1in)

Johnson & Johnson Consumer, Inc.

FDA Devices Moderate Apr 4, 2018

The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surfa

SIE AG, Surgical Instrument Engineering

FDA Devices Moderate Apr 4, 2018

Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number: G18022 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use

Cook Inc.

FDA Devices Critical Apr 4, 2018

6F Taiga Guiding Catheter

Medtronic Inc

FDA Devices Moderate Apr 4, 2018

Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.

Quidel Corporation

FDA Devices Moderate Apr 4, 2018

IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600

Deerfield Imaging, Inc.

FDA Devices Moderate Apr 4, 2018

IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.

Deerfield Imaging, Inc.

FDA Devices Moderate Apr 4, 2018

Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The devices are intended for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.

Cook Vascular Inc.

FDA Devices Moderate Apr 4, 2018

EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet.

Medica Corporation

FDA Devices Moderate Apr 4, 2018

COACH¿ Self-Adhering Sports Wrap (size: 3in)

Johnson & Johnson Consumer, Inc.

FDA Devices Moderate Apr 4, 2018

Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery

Zimmer Biomet, Inc.

FDA Devices Low Apr 4, 2018

Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. Monitored gases includes O2, CO2, N2O and anesthetic agents Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane. It is intended for use in a fixed location such as the operating room or intensive care unit. The Gas Module 3 is compatible with Mindray patient monitors which display the gas

Mindray DS USA, Inc. dba Mindray North America

FDA Devices Moderate Apr 4, 2018

ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B

Arrow International Inc

FDA Devices Moderate Apr 4, 2018

c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692

Roche Diagnostics Corporation

FDA Devices Moderate Apr 4, 2018

SporAmpule Biological Indicator Catalog Number SPS5-100

Mesa Laboratories Bozeman Manufacturing Facility

FDA Devices Moderate Apr 4, 2018

PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

Zimmer Biomet, Inc.

FDA Devices Moderate Apr 4, 2018

Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00, 979105, 14-441045-00, and 14-444000S

Zimmer Biomet, Inc.

FDA Devices Moderate Apr 4, 2018

QUANTA-Lyser 240 EIA, Part #GS0241. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates.

Inova Diagnostics Incorporated

FDA Devices Moderate Apr 4, 2018

Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for orthopedic use.

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Apr 4, 2018

1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, Product Number: 0210-118-200, UDI: (01)4546540861818; 4. InterPulse Irrigation Only Handpiece with Fan Spray Tip, Product Number: 0210-218-000, UDI: (01)4546540144300 for orthopedic use.

Stryker Instruments Div. of Stryker Corporation

FDA Devices Low Apr 4, 2018

STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K

Keystone Dental Inc

FDA Devices Moderate Apr 4, 2018

Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.

Zimmer Dental Inc

FDA Devices Moderate Apr 4, 2018

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

Encore Medical, Lp

FDA Devices Moderate Apr 4, 2018

180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880 for orthopedic use.

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Apr 4, 2018

Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534

Konica Minolta Medical Imaging USA, Inc.

FDA Devices Moderate Apr 4, 2018

ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM STERILE ATN AR SCREW 70MM STERILE ATN AR SCREW 75MM STERILE ATN AR SCREW 80MM STERILE ATN AR SCREW 85MM STERILE ATN AR SCREW 90MM STERILE ATN AR SCREW 95MM STERILE ATN AR SCREW 100MM STERILE The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of the

Zimmer Biomet, Inc.

FDA Devices Moderate Apr 4, 2018

Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 3in)

Johnson & Johnson Consumer, Inc.

FDA Devices Moderate Apr 4, 2018

Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031

Konica Minolta Medical Imaging USA, Inc.

FDA Devices Moderate Apr 4, 2018

cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system) & 04775279973 (disk system).

Roche Diagnostics Corporation

FDA Devices Moderate Apr 4, 2018

ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471

Mesa Laboratories Bozeman Manufacturing Facility

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.