PlainRecalls

2018 Recalls

6,355 recalls · Page 23 of 128

2018 Recall Year Insight

Federal agencies issued 6,355 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.57% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 17.4 recalls per day across the FDA, CPSC, NHTSA, and USDA FSIS 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 128 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 5 critical, 45 moderate, and 0 lower-severity recalls. The page references 20 distinct recalling firms operating in 3 distinct product categories, with 47 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (45), NHTSA (3), CPSC (2), 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, NHTSA, or USDA FSIS 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

STREAMLAB CORE UNIT / LYNX WITH IOM

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R Product Usage: The O-arm Imaging System is…

Medtronic Navigation, Inc.-Littleton

FDA Devices Critical Oct 31, 2018

CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.

Alcon Research, LTD.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

BACT/ALERT VIRTUO system, B 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

CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

APTIO INPUT/OUTPUT MODULE

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Oct 31, 2018

Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are intended for su…

Nakanishi Inc.

FDA Devices Moderate Oct 31, 2018

Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z…

Boston Scientific Corporation

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: YMCIR-400

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

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

bioMerieux, Inc.

FDA Devices Moderate Oct 31, 2018

Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for …

Nakanishi Inc.

FDA Devices Moderate Oct 31, 2018

STREAMLAB - REFRIGERATED STORAGE MODULE 9000

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF (3) 1231-140XL GOWN, SPECIALTY XL, XLO…

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB, Model Number Bl70000027GERR Product Usage: The O-arm Imaging …

Medtronic Navigation, Inc.-Littleton

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (als…

Data Innovations, LLC

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit- COBAN¿, LF (1"X5 YDS) Product Number:D5-14591

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model Number Bl70000027230R Product Usage: The O-arm Imaging Sys…

Medtronic Navigation, Inc.-Littleton

FDA Devices Critical Oct 31, 2018

CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.

Alcon Research, LTD.

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.

CPSC Moderate Oct 31, 2018

CFMOTO Recalls Recreational Off-Highway Vehicles Due to Crash Hazard (Recall Alert)

Zhejiang CFMOTO Power Co. Ltd, of China

CPSC Moderate Oct 31, 2018

Fantasia Accessories Recalls Slap Bracelets Due to Laceration Hazard; Sold Exclusively at Target

Yumark Enterprises Corp/Yumark Pacific LTD., of China

NHTSA Critical Oct 31, 2018

KIA 2019: EXTERIOR LIGHTING:HEADLIGHTS

KIA

NHTSA Critical Oct 29, 2018

MERCEDES-BENZ 2019: ELECTRICAL SYSTEM:SOFTWARE

MERCEDES-BENZ

NHTSA Critical Oct 29, 2018

JEEP 2018: EQUIPMENT:ACCESSORY:FLOOR MAT

JEEP

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 + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2018