PlainRecalls

2015 Recall Year Insight

Federal agencies issued 8,173 product recalls indexed by PlainRecalls in calendar year 2015. That represents about 7.83% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 22.4 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 164 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 2 critical, 45 moderate, and 3 lower-severity recalls. The page references 11 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, USDA FSIS, 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 15, 2015

Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance to patient motion during rehabilitation therapy. The Primus that includes the optional Chop / Lift Bar.

BTE Technologies, Inc.

FDA Devices Moderate Jul 15, 2015

Surgical Pack and General Surgery Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Head & Neck Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Blepharoplasty Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Suction Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

General Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.

Volcano Corp

FDA Devices Moderate Jul 15, 2015

Glaucoma Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Knee Arthro Pack and Knee Arthro Pack II - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Pediatric Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Custom Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with the following indications: Degenerative Disk Disease, Trauma, Tumors, Deformities or curvatures, Psuedoarthrosis, Failed previous fu

Alliance Partners LLC

FDA Devices Moderate Jul 15, 2015

The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a central axis.

Maquet Cardiovascular Us Sales, Llc

FDA Devices Moderate Jul 15, 2015

Standard Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Vein & Vascular Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Hand Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

ENT Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Low Jul 15, 2015

PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

Bard Access Systems

FDA Devices Moderate Jul 15, 2015

Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Low Jul 15, 2015

PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen) (Sherlock) The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

Bard Access Systems

FDA Devices Moderate Jul 15, 2015

Lipo/Buttocks Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Hand Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Vein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pack, Vein Ablation Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Face Lift Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Podiatry Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton.

Allergan Inc

FDA Devices Moderate Jul 15, 2015

Face Neck Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Cysto Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Upper Extremity Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Open Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Advanced Vein Care - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map - 802745-001. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.

Volcano Corp

FDA Devices Moderate Jul 15, 2015

DND Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Tummy Tuck Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Critical Jul 15, 2015

Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers: 2.5NEF,3.0NEF,3.5NEF,4.0NEF,4.5NEF,2.5PEF,3.0PEF,3.5PEF,4.0PEF,4.5PEF,5.0PEF,5.5PEF,5.0PELF,5.5PELF,6.0PELF,6.5PELF,2.5NCF,3.0NCF,3.5NCF,4.0NCF,4.5NCF,2.5PCF,3.0PCF,3.5PCF,4.0PCF,4.5PCF,5.0PCF,5.5PCF,5.0PLCF,5.5PLCF,6.0PLCF,6.5PLCF,3.0NEF-P,3.5NEF-P,4.0NEF-P,4.5NEF-P,3.0PEF-P,3.5PEF-P,4.0PEF-P,4.5PEF-P,5.0PEF-P,5.5PEF-P,

Covidien LP (formerly Nellcor Puritan Bennett Inc.)

FDA Devices Moderate Jul 15, 2015

Minor Pack and Minor Pack II Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions.

Synthes, Inc.

FDA Devices Critical Jul 15, 2015

Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.

Covidien LP (formerly Nellcor Puritan Bennett Inc.)

FDA Devices Moderate Jul 15, 2015

Breast Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Basic Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Laser Evlt Pack and Laser One Leg Evlt - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

ACL Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Face Lift Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Stradi 4500 - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Low Jul 15, 2015

Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.

Volk Optical Inc

FDA Devices Moderate Jul 15, 2015

Breast Augmentation Pack and Breast Augmentation Expanded Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Gyn Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

FDA Devices Moderate Jul 15, 2015

Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer.

Siemens Healthcare Diagnostics, 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: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2015

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 2015 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.