PlainRecalls

2015 Recalls

6,853 recalls · Page 58 of 138

2015 Recall Year Insight

Federal agencies issued 6,853 product recalls indexed by PlainRecalls in calendar year 2015. That represents about 8.16% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 18.8 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 138 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 22 distinct recalling firms operating in 2 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (48), FDA Drug (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 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, NHTSA, or USDA FSIS for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Moderate Jul 29, 2015

Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mu…

Wockhardt Usa Inc.

FDA Drug Moderate Jul 29, 2015

Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-929-01), B) 500 Count Bottles (NDC: 64679-929-05), and C) 1000 Co…

Wockhardt Usa Inc.

FDA Devices Moderate Jul 29, 2015

GE Healthcare Precision 500D Classical R & F system.

GE Healthcare

FDA Devices Moderate Jul 29, 2015

Tool, Stripper W/BLD, 18S, 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

Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in obtainin…

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Jul 29, 2015

Fiber Cleaver; Fiber Cleaver is also used to score the outer jacket on EndoStat Fibers (Aura XP) The Fiber Cleaver is a reusable and sterilizabl…

American Medical Systems Innovation Center - Silicon Valley

FDA Devices Moderate Jul 29, 2015

THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 Product Usage: medical aspirator

Gardner Denver Thomas Inc

FDA Devices Moderate Jul 29, 2015

Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.

Maquet Cardiovascular Us Sales, Llc

FDA Devices Moderate Jul 29, 2015

Tool, Stripper W/BLD, 44S, 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

Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implantation in the capsular ba…

Bausch & Lomb Surgical, Inc.

FDA Devices Moderate Jul 29, 2015

Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100 The Wizard¿" gamma counter is intended to detect and count gamma…

Perkinelmer

FDA Devices Moderate Jul 29, 2015

T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bo…

Argon Medical Devices, Inc

FDA Devices Moderate Jul 29, 2015

Stripper, 0.4mm Disposable EndoStat Fiber, 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

American Catheter / Cholangiogram Catheter 9100 Series.

American Catheter Corp

FDA Devices Moderate Jul 29, 2015

Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check t…

Cochlear Americas Inc.

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

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 + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2015