PlainRecalls

2018 Recalls

Compiled from official public sources by the editorial team.

7,717 recalls · Page 128 of 155

2018 Recall Year Insight

Federal agencies issued 7,717 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.70% of the 100,165 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 7 critical, 41 moderate, and 2 lower-severity recalls. The page references 25 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 Mar 7, 2018

proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components

Aesculap Implant Systems LLC

FDA Devices Moderate Mar 7, 2018

AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to insert the im…

Howmedica Osteonics Corp.

FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Po…

Steris Corporation

FDA Devices Moderate Mar 7, 2018

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

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Mar 7, 2018

A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 14…

Olympus Corporation of the Americas

FDA Devices Critical Mar 7, 2018

Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic

Ventana Medical Systems Inc

FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pou…

Steris Corporation

FDA Devices Critical Mar 7, 2018

iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic

Ventana Medical Systems Inc

FDA Devices Critical Mar 7, 2018

NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic

Ventana Medical Systems Inc

FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Po…

Steris Corporation

FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temp 8"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouc…

Steris Corporation

FDA Devices Moderate Mar 7, 2018

DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacemen…

DePuy Orthopaedics, Inc.

FDA Devices Low Mar 7, 2018

Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correc…

CooperVision Inc.

FDA Devices Moderate Mar 7, 2018

14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Po…

Steris Corporation

FDA Devices Moderate Mar 7, 2018

Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Cat…

Angiodynamics, Inc.

FDA Devices Moderate Mar 7, 2018

AVID TruCustom SHOULDER ARTHROSCOPY convenience kits, Item Code: MADN010-02

Avid Medical, Inc.

FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pou…

Steris Corporation

FDA Devices Critical Mar 7, 2018

CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic

Ventana Medical Systems Inc

FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouc…

Steris Corporation

FDA Devices Moderate Mar 7, 2018

Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding

Cook Inc.

FDA Devices Critical Mar 7, 2018

ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic

Ventana Medical Systems Inc

FDA Devices Moderate Mar 7, 2018

Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.

Teleflex Medical

FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temp 3.5"x22" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Po…

Steris Corporation

FDA Devices Moderate Mar 7, 2018

BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -00842768013102471842…

Siemens Healthcare Diagnostics

FDA Devices Moderate Mar 7, 2018

SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pou…

Steris Corporation

FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temp 3.5"x22" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Po…

Steris Corporation

FDA Devices Moderate Mar 7, 2018

AVID TruCustom MINOR PROCEDURE 6A convenience kits, Item Code: MADN032-01

Avid Medical, Inc.

FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouc…

Steris Corporation

FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pou…

Steris Corporation

FDA Devices Moderate Mar 7, 2018

Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpose of archivi…

Trumpf Medical Systems, Inc.

FDA Devices Moderate Mar 7, 2018

731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant thr…

ZOLL Medical Corporation

FDA Devices Moderate Mar 7, 2018

Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105

Baxter Healthcare Corporation

FDA Devices Critical Mar 7, 2018

OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic

Ventana Medical Systems Inc

FDA Devices Critical Mar 7, 2018

ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic

Ventana Medical Systems Inc

FDA Devices Moderate Mar 7, 2018

AVID TruCustom NEURO PK convenience kits, Item Code: LGHM021-08

Avid Medical, Inc.

FDA Devices Low Mar 7, 2018

VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry …

Ortho Clinical Diagnostics Inc

FDA Devices Moderate Mar 7, 2018

DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replac…

DePuy Orthopaedics, Inc.

FDA Devices Moderate Mar 7, 2018

ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240

Tosoh Bioscience Inc

FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pou…

Steris Corporation

FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pou…

Steris Corporation

FDA Devices Moderate Mar 7, 2018

ADVIA Centaur¿ T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum using the ADVI…

Siemens Healthcare Diagnostics, Inc

FDA Devices Moderate Mar 7, 2018

Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.

Alcon Research, LTD.

FDA Devices Moderate Mar 7, 2018

Foot Controls impacted for the following devices: OAKWORKS¿ Medical CFPM 300 Imaging Table OAKWORKS¿ Medical CFPM 301 Imaging Table OAKWORKS¿ Me…

Oakworks Inc

FDA Devices Moderate Mar 7, 2018

1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the…

DePuy Mitek, Inc., a Johnson & Johnson Co.

FDA Devices Moderate Mar 7, 2018

AVID TruCustom EXTREMITY PACK convenience kits, Item Code: MADN012-01 and MADN012-02

Avid Medical, Inc.

FDA Devices Moderate Mar 7, 2018

Integrity R1.2

Elekta Limited

FDA Devices Moderate Mar 7, 2018

AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is intended to be used for X-ray computed tomography applications for ana…

Mobius Imaging, LLC

FDA Devices Moderate Mar 7, 2018

AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04

Avid 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: CPSC + NHTSA — consumer product and vehicle recall feeds for 2018