2018 Recalls
7,928 federal recalls indexed for 2018 · Page 27 of 159
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 3 critical, 46 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, USDA FSIS, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.
BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.
bioMerieux, Inc.
CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635
Custom Healthcare Systems, Inc.
APTIO INPUT/OUTPUT MODULE
Siemens Healthcare Diagnostics, Inc.
Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible..
Nakanishi Inc.
Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,
Boston Scientific Corporation
CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: YMCIR-400
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112
Custom Healthcare Systems, Inc.
BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.
bioMerieux, Inc.
Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
Nakanishi Inc.
STREAMLAB - REFRIGERATED STORAGE MODULE 9000
Siemens Healthcare Diagnostics, Inc.
CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF (3) 1231-140XL GOWN, SPECIALTY XL, XLONG
Custom Healthcare Systems, Inc.
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB, Model Number Bl70000027GERR Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.
Medtronic Navigation, Inc.-Littleton
CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B
Custom Healthcare Systems, Inc.
IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).
Data Innovations, LLC
CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit- COBAN¿, LF (1"X5 YDS) Product Number:D5-14591
Custom Healthcare Systems, Inc.
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model Number Bl70000027230R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.
Medtronic Navigation, Inc.-Littleton
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.
Alcon Research, LTD.
CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914
Custom Healthcare Systems, Inc.
O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK, Model Number Bl70000027120R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.
Medtronic Navigation, Inc.-Littleton
STREAMLAB - REFRIGERATED STORAGE MODULE 15000
Siemens Healthcare Diagnostics, Inc.
Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.
Medacta Usa Inc
J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures.
Bovie Medical Corporation
APTIO RACK OUTPUT MODULE
Siemens Healthcare Diagnostics, Inc.
TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
Shimadzu Medical Systems Usa Com
CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669
Custom Healthcare Systems, Inc.
Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
Nakanishi Inc.
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number Bl70000027120 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.
Medtronic Navigation, Inc.-Littleton
CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP
Custom Healthcare Systems, Inc.
Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter is designed to enter the disc space, with a fixed engagement between the inserter and the cage and then rotate for desired placement. The three components of the TL Steerable Inserter System include: 1. TL Steerable Inserter 2. TL Steerable Inserter Inner Shaft 3. TL Steerable Inserter Driver
Howmedica Osteonics Corp.
NucliSENS¿ Magnetic Extraction Reagents
BioMerieux SA
Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system Distribute by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument
Ecolab Inc
CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000
Custom Healthcare Systems, Inc.
Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument
Ecolab Inc
CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685
Custom Healthcare Systems, Inc.
Mitek Screw and Washer Depth Gauge, Product Code 219024
DePuy Mitek, Inc., a Johnson & Johnson Co.
Disposable Accessory Kit, 3-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between t
Ecolab Inc
CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201
Custom Healthcare Systems, Inc.
CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.
Alcon Research, LTD.
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV RWK, Model Number Bl70000027100R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.
Medtronic Navigation, Inc.-Littleton
MyLab Gamma, Model 7410
ESAOTE S.P.A.
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010. For ophthalmic use.
Alcon Research, LTD.
CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178
Custom Healthcare Systems, Inc.
Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detection of multiple drugs in human urine. The test is intended as the first step in a two-step process to provide consumers with information concerning the presence or absence of drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process-is provided in the package labeling.
Ameditech Inc
CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914
Custom Healthcare Systems, Inc.
Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body.
Canon Medical System, USA, INC.
CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520
Custom Healthcare Systems, Inc.
SIGNA Architect system Product Usage: The Signa Architect system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, h
GE Medical Systems, LLC
MyLab Alpha, Model 7400
ESAOTE S.P.A.
Nearby Recall Years
Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.
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.