PlainRecalls

2012 Recalls

3,552 recalls · Page 2 of 72

2012 Recall Year Insight

Federal agencies issued 3,552 product recalls indexed by PlainRecalls in calendar year 2012. That represents about 4.23% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 9.7 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 72 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 2012.

On this page of 50 records, severity classification shows 0 critical, 50 moderate, and 0 lower-severity recalls. The page references 28 distinct recalling firms operating in 4 distinct product categories, with 49 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (45), CPSC (4), NHTSA (1), 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 2012 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 Devices Moderate Dec 26, 2012

CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument. The purpose is to hold microscopic slides, dur…

Dako Denmark A/S

FDA Devices Moderate Dec 26, 2012

Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE E, LEFT TIBIA SIZE E RIGHT This de…

Zimmer, Inc.

FDA Devices Moderate Dec 26, 2012

Medrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump System designed for patients who require medications and other fluids du…

Medrad Inc

FDA Devices Moderate Dec 26, 2012

BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFoc…

Del Mar Reynolds Medical, Ltd.

FDA Devices Moderate Dec 26, 2012

DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and cancel…

DePuy Mitek, Inc., a Johnson & Johnson Co.

FDA Devices Moderate Dec 26, 2012

Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstraat 57, B-91…

Becton Dickinson & Company

FDA Devices Moderate Dec 26, 2012

GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patien…

GE Healthcare, LLC

FDA Devices Moderate Dec 26, 2012

Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diameter, Nonsterile This device is indicated for patients with severe kne…

Zimmer, Inc.

FDA Devices Moderate Dec 26, 2012

Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto Ric…

Medtronic Neuromodulation

FDA Devices Moderate Dec 26, 2012

Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and 40918-6. The device is packaged six (6) canes per shipping carton. …

Invacare Corporation

FDA Devices Moderate Dec 26, 2012

Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size D Left; Size D Right This device is used with the Persona…

Zimmer, Inc.

FDA Devices Moderate Dec 26, 2012

Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Ver…

Varian Medical Systems, Inc. Oncology Systems

FDA Devices Moderate Dec 26, 2012

Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the Interventio…

Medline Industries Inc

FDA Devices Moderate Dec 26, 2012

SOL SYS F 8 CALC 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire s…

DePuy Orthopaedics, Inc.

FDA Devices Moderate Dec 26, 2012

SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire s…

DePuy Orthopaedics, Inc.

FDA Devices Moderate Dec 26, 2012

Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 k…

Mindray DS USA, Inc. d.b.a. Mindray North America

FDA Devices Moderate Dec 26, 2012

SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire s…

DePuy Orthopaedics, Inc.

FDA Devices Moderate Dec 26, 2012

Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size C Left; Size C Right This device is used with the Persona…

Zimmer, Inc.

FDA Devices Moderate Dec 26, 2012

Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of c…

Bausch & Lomb Inc

FDA Devices Moderate Dec 26, 2012

SOL SYS R 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire…

DePuy Orthopaedics, Inc.

FDA Devices Moderate Dec 26, 2012

SOL SYS L 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire…

DePuy Orthopaedics, Inc.

FDA Devices Moderate Dec 26, 2012

MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, Model A3101. The MAYFIELD B…

Integra LifeSciences Corporation

FDA Devices Moderate Dec 26, 2012

Persona, The Personalized Knee System, Tibial Broach, Cemented, Size E-F, Nonsterile, This device is used with the Persona Knee System for pat…

Zimmer, Inc.

FDA Devices Moderate Dec 26, 2012

The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels i…

Beckman Coulter Inc.

FDA Devices Moderate Dec 26, 2012

ThyssenKrupp Accessibility LEVANT Stairlift. Intended to mechanically transport one mobility impaired person in a fold-down seat up and down strai…

ThyssenKrupp Access Corp

FDA Devices Moderate Dec 26, 2012

MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutan…

Integra LifeSciences Corporation

FDA Devices Moderate Dec 26, 2012

BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" …

Becton Dickinson & Co.

FDA Devices Moderate Dec 26, 2012

Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside an uncoated Tyvek/PET peel pouch and…

DePuy Orthopaedics, Inc.

FDA Devices Moderate Dec 26, 2012

EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw…

Biomet, Inc.

FDA Devices Moderate Dec 26, 2012

SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire…

DePuy Orthopaedics, Inc.

FDA Devices Moderate Dec 26, 2012

Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and version 8.1) and only when or more …

GE Healthcare, LLC

FDA Devices Moderate Dec 26, 2012

EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation

EEG Info

FDA Devices Moderate Dec 26, 2012

Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; Product Usage: This Complete …

Medline Industries Inc

FDA Devices Moderate Dec 26, 2012

Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR …

TITAN SPINE, LLC

FDA Devices Moderate Dec 26, 2012

Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy System incl…

Arobella Medical, LLC

FDA Devices Moderate Dec 26, 2012

Medrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System designed for patients who require medications and other fluids during a…

Medrad Inc

FDA Devices Moderate Dec 26, 2012

Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for application wi…

Biomet, Inc.

FDA Devices Moderate Dec 26, 2012

Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile, This device is used with the Persona Knee System for pat…

Zimmer, Inc.

FDA Devices Moderate Dec 26, 2012

SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is operated by means of 12-inch Color LCD tou…

BioMotion Medical Systems, LLC

FDA Devices Moderate Dec 26, 2012

SOL SYS R 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire…

DePuy Orthopaedics, Inc.

FDA Devices Moderate Dec 26, 2012

Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE F, LEFT TIBIA SIZE F RIGHT This de…

Zimmer, Inc.

FDA Devices Moderate Dec 26, 2012

SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire st…

DePuy Orthopaedics, Inc.

FDA Devices Moderate Dec 26, 2012

Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristaltic Pump System designed for patients who require medications and other…

Medrad Inc

FDA Devices Moderate Dec 26, 2012

Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 mm Diameter, Nonsterile, Nonsterile This drill guide is used with the …

Zimmer, Inc.

FDA Devices Moderate Dec 26, 2012

Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1 Product Usage: The ulnar…

Zimmer, Inc.

CPSC Moderate Dec 26, 2012

American Honda Expands Recall of FourTrax ATVs Due to Crash Hazard

American Honda Motor Co. Inc., of Torrance, Calif.

CPSC Moderate Dec 26, 2012

Bethlehem Lights Recalls Christmas Trees Sold Exclusively by QVC Due to Fire Hazard

GKI Bethlehem Lights of Taunton, Mass.

NHTSA Moderate Dec 21, 2012

FREIGHTLINER 2012: EQUIPMENT

FREIGHTLINER

CPSC Moderate Dec 20, 2012

Muddy Outdoors Recalls Climbing Sticks Due to Risk of Serious Injury or Death

Classic Asia Group, of China

CPSC Moderate Dec 20, 2012

PAPYRUS Signature Collection Frames Recalled Due to Risk of Exposure to Mold

Idianale Inc./Dekokraft, Inc., of Pasig City, Philippines

Nearby Recall Years

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

Compare 2012 with 2011 →

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 2012