PlainRecalls

2015 Recalls

Compiled from official public sources by the editorial team.

8,016 recalls · Page 2 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 5 critical, 18 moderate, and 27 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 Low Dec 30, 2015

ProScreen 5 Panel Dip Card, Item No. PSD-12BUP

Ameditech Inc

FDA Devices Moderate Dec 30, 2015

Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.

Terumo Medical Corp

FDA Devices Moderate Dec 30, 2015

Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the p…

CareFusion 303, Inc.

FDA Devices Moderate Dec 30, 2015

Ingenuity Core 128 Computed Tomography X-ray system

Philips Medical Systems (Cleveland) Inc

FDA Devices Low Dec 30, 2015

ProScreen 7 Panel Dip Card, Item No. PSD-7MPB, PSD-7MO, PSD-7M

Ameditech Inc

FDA Devices Low Dec 30, 2015

DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D DrugSmart 12 Test Cup (Multi/Single/BUP), Item No. 61205D

Ameditech Inc

FDA Devices Low Dec 30, 2015

ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU

Ameditech Inc

FDA Devices Low Dec 30, 2015

11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA

Ameditech Inc

FDA Devices Moderate Dec 30, 2015

Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimen…

Siemens Healthcare Diagnostics Inc.

FDA Devices Low Dec 30, 2015

ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB300

Ameditech Inc

FDA Devices Moderate Dec 30, 2015

Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and …

Synaptive Medical, Inc.

FDA Devices Critical Dec 30, 2015

Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the …

Draeger Medical, Inc.

FDA Devices Low Dec 30, 2015

THERMO FISHER 8 DRUG CASSETTE, Item No. MTPA-8MBAU

Ameditech Inc

FDA Devices Low Dec 30, 2015

CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5

Ameditech Inc

FDA Devices Low Dec 30, 2015

Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU

Ameditech Inc

FDA Devices Critical Dec 30, 2015

Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-ne…

Biomerieux

FDA Devices Low Dec 30, 2015

DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600D

Ameditech Inc

FDA Devices Low Dec 30, 2015

ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W

Ameditech Inc

FDA Devices Moderate Dec 30, 2015

MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge con…

Cardica, Inc.

FDA Devices Moderate Dec 30, 2015

Green Mamba Suture Passer

Biomet, Inc.

FDA Devices Moderate Dec 30, 2015

Ingenuity Core Computed Tomography X-ray system

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Dec 30, 2015

FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp.,…

Hardy Diagnostics

FDA Devices Low Dec 30, 2015

iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142

Ameditech Inc

FDA Devices Low Dec 30, 2015

12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX, PSD-10MOX, 60960D, 61127D, DCC-81205-5, IMCA-10M5.

Ameditech Inc

FDA Devices Moderate Dec 30, 2015

IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: M004PM4790N40; Catalog number: PM4790N4; Cardiac: The IntellaTip M…

Boston Scientific Corp

FDA Devices Moderate Dec 30, 2015

Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.

Airways Development LLC

FDA Devices Moderate Dec 30, 2015

Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Low Dec 30, 2015

DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5

Ameditech Inc

FDA Devices Low Dec 30, 2015

ProScreen 6 Panel Dip Drug Screen, Item No. PSD-6BUPO3

Ameditech Inc

FDA Devices Moderate Dec 30, 2015

Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.

Siemens Medical Solutions USA, Inc

FDA Devices Critical Dec 30, 2015

Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-…

Biomerieux

FDA Devices Low Dec 30, 2015

Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP

Ameditech Inc

FDA Devices Low Dec 30, 2015

ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W, PSCup-10MMO300, P…

Ameditech Inc

FDA Devices Critical Dec 30, 2015

Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number (UPN) Guiding Sheath 5F, 4…

Boston Scientific Corporation

FDA Devices Moderate Dec 30, 2015

Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depend…

Aesculap, Inc.

FDA Devices Moderate Dec 30, 2015

BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer¿ tubes are used to collect, transport and process bl…

Becton Dickinson & Company

FDA Devices Low Dec 30, 2015

ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300

Ameditech Inc

FDA Devices Low Dec 30, 2015

THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU

Ameditech Inc

FDA Devices Low Dec 30, 2015

ProScreen 8 Panel Dip Card, Item No. PSD-8P

Ameditech Inc

FDA Devices Moderate Dec 30, 2015

Cardinal Health Tiny Toes; 11470-010T Infant heel warmer

Philips Electronics North America Corporation

FDA Devices Low Dec 30, 2015

ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300

Ameditech Inc

FDA Devices Moderate Dec 30, 2015

A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions…

Biomet, Inc.

FDA Devices Low Dec 30, 2015

Immutest Cup CLIA Waived w/Adulteration, Item No. IMCA-7MT-W

Ameditech Inc

FDA Devices Low Dec 30, 2015

DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D

Ameditech Inc

FDA Devices Low Dec 30, 2015

DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.

BC Group International Inc

FDA Devices Low Dec 30, 2015

DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D

Ameditech Inc

FDA Devices Low Dec 30, 2015

ProScreen 6 Panel Dip Card w/Adult (AU), Item No. PSDA-6MBAU

Ameditech Inc

FDA Devices Low Dec 30, 2015

ProScreen 12 Panel Dip Card, Item No. PSD-12BUP

Ameditech Inc

FDA Devices Moderate Dec 30, 2015

IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Number: M004EPM4500N40; Catalog number: EPM4500N4; Cardiac: The Intella…

Boston Scientific Corp

FDA Devices Critical Dec 30, 2015

Etest¿ Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest¿ is a quantitative technique for determining the antimicrobial sus…

Biomerieux

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 July 2026.