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 4 critical, 45 moderate, and 1 lower-severity recalls. The page references 17 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 Mar 7, 2018

OTTO BOCK Kenevo knee joints Model 3C60

Otto Bock Healthcare Product

FDA Devices Moderate Mar 7, 2018

Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). The Allura Xper FD20, Allura Xper FD20/10, Allura Xper FD20/15 and Allura Xper FD10/10 is intended for: Dedicated vascular and neurovascular imaging

Philips Electronics North America Corporation

FDA Devices Critical Mar 7, 2018

CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic

Ventana Medical Systems Inc

FDA Devices Moderate Mar 7, 2018

Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item No. 00585001202); c. Size C-LT (Item No. 00585001301); d. Size C-RT (Item No. 00585001302) Components of the system are intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia, and/or total knee in cases that require extensive resection and restoration.

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 7, 2018

Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.

Stryker Communications

FDA Devices Moderate Mar 7, 2018

Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Mar 7, 2018

AVID TruCustom LOWER EXTREMITY convenience kits, Item Code: LGHM038-03 and LGHM038-04

Avid Medical, Inc.

FDA Devices Moderate Mar 7, 2018

MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Y-Site with Check Valve, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.

Zevex Incorporated (dba Moog Medical Medical Devices Group)

FDA Devices Moderate Mar 7, 2018

SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 11061618 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a trained physician as an aid in diagnosis. These CT systems can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies. Please refer to

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Mar 7, 2018

MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.

Medistim Asa

FDA Devices Moderate Mar 7, 2018

Truth Renew

Accord Media, LLC

FDA Devices Moderate Mar 7, 2018

AVID TruCustom HEART CATH TRAY convenience kits, Item Code: LAKC022-06

Avid Medical, Inc.

FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temp 5"x15" Heat Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

Steris Corporation

FDA Devices Critical Mar 7, 2018

OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic

Ventana Medical Systems Inc

FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

Steris Corporation

FDA Devices Moderate Mar 7, 2018

Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 7, 2018

AVID TruCustom GYN LAPAROSCOPY convenience kits, Item Code: LGHM013-06 and LGHM013-07

Avid Medical, Inc.

FDA Devices Moderate Mar 7, 2018

Artis Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10848355

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Mar 7, 2018

AVID TruCustom SPINE convenience kits, Item Code: LITT016-04

Avid Medical, Inc.

FDA Devices Critical Mar 7, 2018

OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic

Ventana Medical Systems Inc

FDA Devices Moderate Mar 7, 2018

MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Ultrasite Needleless Injection Port (Positive Pressure), Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral

Zevex Incorporated (dba Moog Medical Medical Devices Group)

FDA Devices Moderate Mar 7, 2018

AVID TruCustom UPPER EXTREMITY convenience kits, Item Code: LGHM050-03 and LGHM050-04

Avid Medical, Inc.

FDA Devices Moderate Mar 7, 2018

AVID TruCustom DJ'S VASCULAR/NEURO TRAY convenience kits, Item Code: AV010930-12

Avid Medical, Inc.

FDA Devices Moderate Mar 7, 2018

MOOG Curlin Infusion Administration Set, Ref 340-4166, Non-DEHP Microbore Tubing with Non-Vented Spike, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.

Zevex Incorporated (dba Moog Medical Medical Devices Group)

FDA Devices Moderate Mar 7, 2018

digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a radiographic system, the Philips ProGrade is intended to acquire, process, store, display, and export digital radiographic images. The Philips ProGrade is suitable for all routine radiographic examinations, including specialist area like intensive care, trauma, or pediatric work, excluding mammography. United States only: The Eleva Workspot is not intended for fluoroscopy and angiograph

Philips Electronics North America Corporation

FDA Devices Moderate Mar 7, 2018

V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)

Steris Corporation

FDA Devices Moderate Mar 7, 2018

Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Mar 7, 2018

NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI- M535SAK4050, 8) REF SAK-406 UDI-M535SAK4060 & REF SAK-407 UDI- M535SAK4070 Hemodialysis systems and accessories

NxStage Medical, Inc.

FDA Devices Moderate Mar 7, 2018

MOOG Curlin Infusion Administration Set, Ref 340-4168, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Female Luer Y-Site with Check Valve, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.

Zevex Incorporated (dba Moog Medical Medical Devices Group)

FDA Devices Moderate Mar 7, 2018

STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (Catalog Numbers: (1) S2-12 N, STAT 2¿ Extension Set Gravity Flow Controller (Needle-Free), 12 length, (2) S2V-20 N, STAT 2¿ Primary Administration Set Gravity Flow Controller (Needle-Free), 20 Drops/ml, 84 length, and (3) S2V-60 N, STAT 2¿ Primary Administration Set Gravity Flow Controller (Needle-Free), 60 Drops/ml, 84 length) The STAT 2¿ Extension sets are for use in conjunction with commonly a

ConMed Corporation

FDA Devices Low Mar 7, 2018

JANUS & JANUS G3 Automated Workstation is an automated programmable liquid handling instrument intended for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation work flows.

Perkinelmer Life Sciences, Inc.

FDA Devices Moderate Mar 7, 2018

The 2nd Assist Knee Positioner

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 7, 2018

Truth Renew Plus

Accord Media, LLC

FDA Devices Moderate Mar 7, 2018

Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906); b. VERSYS 6 INCH BEADED FC 21X160MM STD BODY STD NECK (Item No. 00784302106); c. VERSYS 6 INCH BEADED FC 22X160MM STD BODY STD NECK (Item No. 00784302206); d. VERSYS 6 INCH BEADED FC STEM 19X160MM LM (Item No. 00784301936); e. VERSYS 6 INCH BEADED FC STEM 20X160MM LM (Item No. 00784302036); f. VERSYS 6 INCH BEADED FC STEM 21X160M

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

Steris Corporation

FDA Devices Critical Mar 7, 2018

ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic

Ventana Medical Systems Inc

FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temp 10.5"x28" Self Seal Pouch 100 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

Steris Corporation

FDA Devices Moderate Mar 7, 2018

Syngo.via systems with SW VB20A

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Mar 7, 2018

ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.

Atrium Medical Corporation

FDA Devices Moderate Mar 7, 2018

Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, Model#14-442093 Antegrade Femoral Connecting Bolt. orthopedic instrument

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 7, 2018

AVID TruCustom LAMINECTOMY PACK convenience kits, Item Code: MADN013-02

Avid Medical, Inc.

FDA Devices Moderate Mar 7, 2018

Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)

Circulatory Technology Inc

FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

Steris Corporation

FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

Steris Corporation

FDA Devices Moderate Mar 7, 2018

MOOG Curlin Infusion Administration Set, Ref 340-4114, Non-DEHP Microbore Tubing with Non-Vented Bag Spike, packaged 20/box, for use with the MOOG Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.

Zevex Incorporated (dba Moog Medical Medical Devices Group)

FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

Steris Corporation

FDA Devices Moderate Mar 7, 2018

AVID TruCustom ELECTRO PHYSIOLOGY PK convenience kits, Item Code: LGHM033-04

Avid Medical, Inc.

FDA Devices Moderate Mar 7, 2018

ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239

Tosoh Bioscience Inc

FDA Devices Moderate Mar 7, 2018

Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000. Product Usage: Chromophare surgical lights are medical lights for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations. The Chrom

Stryker Communications

FDA Devices Moderate Mar 7, 2018

Ultra Renew

Accord Media, LLC

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.