PlainRecalls

2015 Recalls

7,953 recalls · Page 91 of 160

2015 Recall Year Insight

Federal agencies issued 7,953 product recalls indexed by PlainRecalls in calendar year 2015. That represents about 9.47% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 21.8 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 160 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 3 critical, 42 moderate, and 5 lower-severity recalls. The page references 17 distinct recalling firms operating in 3 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (46), FDA Drug (4), 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 Drug Moderate Jun 17, 2015

Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Montana Compounding Pharmacy

FDA Drug Moderate Jun 17, 2015

Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA by Hi-Tech…

Akorn, Inc.

FDA Drug Moderate Jun 17, 2015

Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Montana Compounding Pharmacy

FDA Drug Moderate Jun 17, 2015

Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Montana Compounding Pharmacy

FDA Devices Moderate Jun 17, 2015

VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in vitro …

Ortho-Clinical Diagnostics

FDA Devices Moderate Jun 17, 2015

MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 17, 2015

CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jun 17, 2015

MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 17, 2015

Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment b…

Biomet, Inc.

FDA Devices Moderate Jun 17, 2015

R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO, Product Usage: The R3 Constrained liner Acetabular System i…

Smith & Nephew, Inc.

FDA Devices Moderate Jun 17, 2015

GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 17, 2015

Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc

FDA Devices Low Jun 17, 2015

RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus …

Acclarent, Inc.

FDA Devices Moderate Jun 17, 2015

HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-sta…

HeartWare Inc

FDA Devices Moderate Jun 17, 2015

GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 17, 2015

BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample collection.

Becton Dickinson & Co.

FDA Devices Low Jun 17, 2015

Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement compon…

Biomet, Inc.

FDA Devices Moderate Jun 17, 2015

Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 17, 2015

Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.

Vilex In Tennessee Inc

FDA Devices Moderate Jun 17, 2015

Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT,…

Gyrus Acmi, Incorporated

FDA Devices Moderate Jun 17, 2015

Brilliance CT 6 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 17, 2015

Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 17, 2015

Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 17, 2015

Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 17, 2015

Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample and data man…

Ortho-Clinical Diagnostics

FDA Devices Low Jun 17, 2015

Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK; 32MM MOD HEAD COCR STD NECK ; 32MM MOD HEAD CO…

Biomet, Inc.

FDA Devices Moderate Jun 17, 2015

Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc

FDA Devices Critical Jun 17, 2015

FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populat…

Maquet Cardiovascular Us Sales, Llc

FDA Devices Moderate Jun 17, 2015

FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 17, 2015

TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging sys…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 17, 2015

EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disin…

Advanced Sterilization Products

FDA Devices Moderate Jun 17, 2015

BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 17, 2015

R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is…

Smith & Nephew, Inc.

FDA Devices Moderate Jun 17, 2015

Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 17, 2015

Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT,…

Gyrus Acmi, Incorporated

FDA Devices Moderate Jun 17, 2015

Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 17, 2015

VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro d…

Ortho-Clinical Diagnostics

FDA Devices Moderate Jun 17, 2015

AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.

Roche Diabetes Care, Inc.

FDA Devices Moderate Jun 17, 2015

AccuChek Spirit insulin infusion pump.

Roche Diabetes Care, Inc.

FDA Devices Critical Jun 17, 2015

HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to card…

HeartWare Inc

FDA Devices Moderate Jun 17, 2015

Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging syste…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 17, 2015

Gemini 16 PET/CT System (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc

FDA Devices Low Jun 17, 2015

Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size…

Biomet, Inc.

FDA Devices Critical Jun 17, 2015

HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: For use …

HeartWare Inc

FDA Devices Moderate Jun 17, 2015

Brilliance CT 40 - Slices(Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 17, 2015

R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is…

Smith & Nephew, Inc.

FDA Devices Low Jun 17, 2015

MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components i…

Biomet, Inc.

FDA Devices Moderate Jun 17, 2015

AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jun 17, 2015

Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE…

Smiths Medical Asd Inc

FDA Devices Moderate Jun 17, 2015

Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)

Advanced Back Technologies, 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