PlainRecalls

2015 Recalls

8,016 recalls · Page 68 of 161

2015 Recall Year Insight

Federal agencies issued 8,016 product recalls indexed by PlainRecalls in calendar year 2015. That represents about 7.88% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 22.0 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 161 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 2015.

On this page of 50 records, severity classification shows 0 critical, 50 moderate, and 0 lower-severity recalls. The page references 20 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 2015 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 Jul 29, 2015

Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; …

Volcano Corporation

FDA Devices Moderate Jul 29, 2015

ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Decription: 573328 7437-NRF SURGICAL ASC KIT 50000511 7516-UNI U…

Covidien LLC

FDA Devices Moderate Jul 29, 2015

Fiber Stripper, 150¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureF…

American Medical Systems Innovation Center - Silicon Valley

FDA Devices Moderate Jul 29, 2015

Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451.…

Philips Electronics North America Corporation

FDA Devices Moderate Jul 29, 2015

Tool, StripperW/BLD, 10S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or S…

American Medical Systems Innovation Center - Silicon Valley

FDA Devices Moderate Jul 29, 2015

HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage…

Hardy Diagnostics

FDA Devices Moderate Jul 29, 2015

Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; …

Volcano Corporation

FDA Devices Moderate Jul 29, 2015

Single Basin Kits, Sterile-.Kits containing the Devon Light Glove Catalog Number/Description: 573509 7696-GSL-VL SINGLE BASIN KIT 573558 7665-CP…

Covidien LLC

FDA Devices Moderate Jul 29, 2015

Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use cover for compatible surgical light handles. Catalog/Number/…

Covidien LLC

FDA Devices Moderate Jul 29, 2015

Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 The Wizard¿" gamma counter is intended to detect and count gamma radiati…

Perkinelmer

FDA Devices Moderate Jul 29, 2015

ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is desig…

Abbott Laboratories

FDA Devices Moderate Jul 29, 2015

Fiber Stripper, 550¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureF…

American Medical Systems Innovation Center - Silicon Valley

FDA Devices Moderate Jul 29, 2015

Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used f…

CooperSurgical, Inc.

FDA Devices Moderate Jul 29, 2015

The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. T…

EKOS Corporation

FDA Devices Moderate Jul 29, 2015

ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to functio…

DePuy Orthopaedics, Inc.

FDA Devices Moderate Jul 29, 2015

Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470-0150 The Wizard¿" gamma counter is intended to detect and count gamm…

Perkinelmer

FDA Devices Moderate Jul 29, 2015

0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (120V) 0702-001-000R, Repair Neptune 2 Rover 0702-002-000, Neptune 2 R…

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Jul 29, 2015

Bausch & Lomb SofPort Advanced Optics Aspheric Lens

Bausch & Lomb Surgical, Inc.

FDA Devices Moderate Jul 29, 2015

Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUBASSEMBLY SA1578 NO-STERILE SUBASSEMBLY SA2000 NON STERILE SUBASSEMBLY …

Covidien LLC

FDA Devices Moderate Jul 29, 2015

Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software ki…

Volcano Corporation

FDA Devices Moderate Jul 29, 2015

ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function…

DePuy Orthopaedics, Inc.

FDA Devices Moderate Jul 29, 2015

Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.

Custom Healthcare Systems, Inc.

FDA Devices Moderate Jul 29, 2015

Double Basin Kit ,Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31145504 7708 Double Basin Kit 50007898 7898-T8 Doubl…

Covidien LLC

FDA Devices Moderate Jul 29, 2015

GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) a…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jul 29, 2015

Tool, Stripper W/BLD, 12S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or S…

American Medical Systems Innovation Center - Silicon Valley

FDA Devices Moderate Jul 29, 2015

Tool, Stripper W/BLD, 44S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat o…

American Medical Systems Innovation Center - Silicon Valley

FDA Devices Moderate Jul 29, 2015

Tool, Stripper W/BLD, 28S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or S…

American Medical Systems Innovation Center - Silicon Valley

FDA Devices Moderate Jul 29, 2015

PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton …

Hitachi America, Ltd., Power Systems Division

FDA Devices Moderate Jul 29, 2015

Tool, Stripper W/BLD, 14S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat o…

American Medical Systems Innovation Center - Silicon Valley

FDA Devices Moderate Jul 29, 2015

200¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to…

American Medical Systems Innovation Center - Silicon Valley

FDA Devices Moderate Jul 29, 2015

Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573208 7519-DHCG MINOR KIT 573210 7581-CSD Minor K…

Covidien LLC

FDA Devices Moderate Jul 29, 2015

Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems. Intended to produce cross-sectional images of the body by computer reco…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jul 29, 2015

ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to functio…

DePuy Orthopaedics, Inc.

FDA Devices Moderate Jul 29, 2015

Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow A…

Argon Medical Devices, Inc

FDA Devices Moderate Jul 29, 2015

Sureflex 273 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not lim…

American Medical Systems Innovation Center - Silicon Valley

FDA Devices Moderate Jul 29, 2015

EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are indicated for ablation, resec…

ArthroCare Corporation

FDA Devices Moderate Jul 29, 2015

GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) a…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jul 29, 2015

Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit

Covidien LLC

FDA Devices Moderate Jul 29, 2015

Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:Description 573831B MAJOR KIT

Covidien LLC

FDA Devices Moderate Jul 29, 2015

365¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to…

American Medical Systems Innovation Center - Silicon Valley

FDA Devices Moderate Jul 29, 2015

Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver acces…

Cook Inc.

FDA Devices Moderate Jul 29, 2015

ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to functi…

DePuy Orthopaedics, Inc.

FDA Devices Moderate Jul 29, 2015

Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and r…

Allergan Inc

FDA Devices Moderate Jul 29, 2015

Fiber Stripper, 365¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureF…

American Medical Systems Innovation Center - Silicon Valley

FDA Devices Moderate Jul 29, 2015

Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard¿" gamma counter is intended to detect and count gamma radiation e…

Perkinelmer

FDA Devices Moderate Jul 29, 2015

1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The t…

American Medical Systems Innovation Center - Silicon Valley

FDA Devices Moderate Jul 29, 2015

Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.

Silhouette Lift, Inc.

FDA Devices Moderate Jul 29, 2015

GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) …

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jul 29, 2015

Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jul 29, 2015

Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop …

Allergan Inc

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2015 with 2014 →

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 2015

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 2015 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 August 2026.