PlainRecalls

2018 Recalls

Compiled from official public sources by the editorial team.

7,795 recalls · Page 27 of 156

2018 Recall Year Insight

Federal agencies issued 7,795 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.66% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 21.4 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 156 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 2 critical, 47 moderate, and 1 lower-severity recalls. The page references 21 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 Oct 31, 2018

CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK, Model Number Bl70000027120R Product Usage: The O-arm Imagin…

Medtronic Navigation, Inc.-Littleton

FDA Devices Moderate Oct 31, 2018

STREAMLAB - REFRIGERATED STORAGE MODULE 15000

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Oct 31, 2018

Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surge…

Medacta Usa Inc

FDA Devices Moderate Oct 31, 2018

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,…

Bovie Medical Corporation

FDA Devices Moderate Oct 31, 2018

APTIO RACK OUTPUT MODULE

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Oct 31, 2018

TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiogr…

Shimadzu Medical Systems Usa Com

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for su…

Nakanishi Inc.

FDA Devices Moderate Oct 31, 2018

O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number Bl70000027120 Product Usage: The O-arm Imaging System is…

Medtronic Navigation, Inc.-Littleton

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is …

Howmedica Osteonics Corp.

FDA Devices Moderate Oct 31, 2018

NucliSENS¿ Magnetic Extraction Reagents

BioMerieux SA

FDA Devices Moderate Oct 31, 2018

Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si R…

Ecolab Inc

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robot…

Ecolab Inc

FDA Devices Moderate Oct 31, 2018

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.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

Mitek Screw and Washer Depth Gauge, Product Code 219024

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

FDA Devices Moderate Oct 31, 2018

Disposable Accessory Kit, 3-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da …

Ecolab Inc

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201

Custom Healthcare Systems, Inc.

FDA Devices Critical Oct 31, 2018

CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.

Alcon Research, LTD.

FDA Devices Moderate Oct 31, 2018

O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV RWK, Model Number Bl70000027100R Product Usage: The O-arm Imaging Sys…

Medtronic Navigation, Inc.-Littleton

FDA Devices Moderate Oct 31, 2018

MyLab Gamma, Model 7410

ESAOTE S.P.A.

FDA Devices Critical Oct 31, 2018

CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010. For ophthalmic use.

Alcon Research, LTD.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178

Custom Healthcare Systems, Inc.

FDA Devices Low Oct 31, 2018

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 …

Ameditech Inc

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coro…

Canon Medical System, USA, INC.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

SIGNA Architect system Product Usage: The Signa Architect system is a whole body magnetic resonance scanner designed to support high resolution, …

GE Medical Systems, LLC

FDA Devices Moderate Oct 31, 2018

MyLab Alpha, Model 7400

ESAOTE S.P.A.

FDA Devices Moderate Oct 31, 2018

Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usag…

Nakanishi Inc.

FDA Devices Moderate Oct 31, 2018

Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusabl…

Smith & Nephew, Inc.

FDA Devices Moderate Oct 31, 2018

Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage …

Nakanishi Inc.

FDA Devices Moderate Oct 31, 2018

MyLab Seven, Model 6400

ESAOTE S.P.A.

FDA Devices Moderate Oct 31, 2018

GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.

GE Medical Systems, LLC

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Number:1231-050L

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 71…

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Oct 31, 2018

O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, Model Number Bl70000027100 Product Usage: The O-arm Imaging System is…

Medtronic Navigation, Inc.-Littleton

FDA Devices Moderate Oct 31, 2018

O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, Model Number Bl7000002 7230 Product Usage: The O-arm Imaging System i…

Medtronic Navigation, Inc.-Littleton

FDA Devices Moderate Oct 31, 2018

VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus Endoscopic Vessel Harvesting Sy…

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Oct 31, 2018

BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated micro…

bioMerieux, Inc.

FDA Devices Moderate Oct 31, 2018

Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da …

Ecolab Inc

FDA Devices Moderate Oct 31, 2018

Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN BF40180 (Pouch level) - BF40181(Case box level) BF40182 (Cart…

Micro-Tech (Nanjing) Co., Ltd.

FDA Devices Moderate Oct 31, 2018

O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GER, Model Number Bl70000027GER Product Usage: The O-arm Imaging Syste…

Medtronic Navigation, Inc.-Littleton

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for s…

Nakanishi Inc.

FDA Devices Moderate Oct 31, 2018

APTIO 9000 REFRIGERATED STORAGE MODULE

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Oct 31, 2018

APTIO CENTRIFUGE MODULE

Siemens Healthcare Diagnostics, 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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Figures cover calendar year 2018 across the FDA, CPSC 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 July 2026.