PlainRecalls

2012 Recall Year Insight

Federal agencies issued 4,173 product recalls indexed by PlainRecalls in calendar year 2012. That represents about 4.00% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 11.4 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 84 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 10 critical, 34 moderate, and 6 lower-severity recalls. The page references 37 distinct recalling firms operating in 7 distinct product categories, with 47 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (27), FDA Food (8), FDA Drug (8), 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, 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 Aug 1, 2012

Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Limited to skeletally mature patients with the exception of the small stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of these indications: degenerative disc disease, spond

Synthes (USA) Products LLC

FDA Devices Moderate Aug 1, 2012

Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bottles. Product Usage: The product is used as a patient lubricant which eases insertion of earmolds and hearing instruments such as hearing aids.

Westone Laboratories, Inc.

FDA Devices Moderate Aug 1, 2012

ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Aug 1, 2012

PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient

Tripath Imaging, Inc.

FDA Devices Moderate Aug 1, 2012

System 1 Base 220/240V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Aug 1, 2012

PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Catalog 490954); PrepStain PM Kit XLP, T-US-II (Catalog 490424); PrepStain Prep PM Kit XLP T-US-II (Catalog 491118); PrepStain Prep Only PM Kit XLP, T-US-II (490423); PrepStain Prep Only PM Kit, T-US (Catalog 490429); PrepStain PM Kit, T-US (Catalog 490626); PrepStain PM Kit Europe, T-US (Catalog 490428). The PrepStain System is a liquid-based thin layer cell preparation proces

Tripath Imaging, Inc.

FDA Devices Moderate Aug 1, 2012

Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The Modular Stem bodies are made of TMZF alloy, developed specifically for orthopaedic applications. Rejuvenate Modular Necks The Rejuvenate Modular Necks are made of Cobalt Chrome. The necks in this system consist of 4 lengt

Stryker Howmedica Osteonics Corp.

FDA Devices Critical Aug 1, 2012

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

GE OEC Medical Systems, Inc

FDA Devices Moderate Aug 1, 2012

System 1 Base 100/120V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Terumo Cardiovascular Systems Corporation

CPSC No agency class Aug 1, 2012

Stage and Riser Caddies Recalled by Midwest Folding Products Due to Risk of Injury or Death Child died when stage stored on caddy fell on her

Midwest Folding Products, of Chicago, Ill.

NHTSA No agency class Aug 1, 2012

MITSUBISHI 2012: AIR BAGS:FRONTAL:SENSOR/CONTROL MODULE-INACTIVE

MITSUBISHI

CPSC No agency class Jul 31, 2012

Green Toys Recalls Mini Vehicles Due To Choking Hazard

Green Toys Inc., of Mill Valley, Calif.

CPSC No agency class Jul 31, 2012

Liberty Mountain Recalls VAUDE Kenta Child Carriers Due to Fall Hazard

VAUDE Sport GmbH & Company KG, of Germany

NHTSA No agency class Jul 27, 2012

MAZDA 2001-2008: ENGINE AND ENGINE COOLING

MAZDA

CPSC No agency class Jul 26, 2012

Motion Sensing Security Lights Recalled by HeathCo due to Electrical Shock Hazard Sold Exclusively at Home Depot

HeathCo LLC, of Bowling Green, Ky.

NHTSA No agency class Jul 26, 2012

FORD 2001-2004: ENGINE AND ENGINE COOLING

FORD

FDA Food Critical Jul 25, 2012

Probitotic Dietary Supplement. : iFlora¿ Kids Multi-Probiotic¿

Nutri-Health Supplements Llc.

FDA Food Moderate Jul 25, 2012

Abbott Acres, Meal Pals, Zesty Bean Dip, Ingredients: water, pinto beans, soybean oil, tomato paste, less than 2% sugar, , salt jalapeno peppers, dehydrated onions, vinegar, sorbic acid (as a preservative), citric acid, caramel color, FD&C yellow #5, paprika, red bell pepper, sodium benzoate (as a preservative), pepper concentrate, gallic powder, Net WT 3 0z ( 85 g), Dist by JA Foodservice, Buchanan, MI 49107

Old Fashioned Foods, Inc.

FDA Food Critical Jul 25, 2012

SP Standard Process, Cataplex C, Dietary Supplement, (Product # 1650 and 1655) , 90 & 360 Tablets, Proprietary Blend: Veal bone PMG extract, bovine adrenal, dried buckwheat (leaf) juice, buckwheat (seed), nutritional yeast, dried alfalfa( whole plant) juice, alfalfa flour, mushroom , magnesium citrate, bovine bone, deflated wheat (germ), calcium acid phosphate, Echinacea(root), carrot (root), veal bone, soybean lecithin, mixed tocopherols (soy , and rice (bran)., Other Ingredients calcium lacta

Standard Process, Inc.

FDA Food Moderate Jul 25, 2012

Old Fashioned Foods, Jalapeno Bean Dip, Ingredients: water, pinto beans, partially hydrogenated soybean oil, red bell pepper, jalapeno peppers, salt, dehydrated onions, green bell peppers, sorbic acid (as a preservative), vinegar, citric acid, paprika, ,pepper flavor, gallic powder,Net WT, 3 oz (86g), MFG by Old Fashioned Foods, Mayville, WI, 53050

Old Fashioned Foods, Inc.

FDA Food Critical Jul 25, 2012

SP Standard Process, Cataplex ACP (Product #0700 and 0750) , Dietary supplement, 90 & 360 Tablets, Proprietary Blend: Dried buckwheat ( leaf) juice, buckwheat (seed), carrot (root), calcium lactate, nutritional yeast, bovine adrenal, bovine kidney, alfalfa flour, dried alfalfa, (whole plant) juice, magnesium citrate, mushroom, bovine bone, Echinacea (root, deflated wheat, (germ), oat flour, soybean lecithin, yeast bone, calcium acid, phosphate, mixed tocopherols, (soy), rice (bran), and carrot

Standard Process, Inc.

FDA Food Critical Jul 25, 2012

Standard Process, Pancreatrophin PMG (Product # 6650), 90 Tablets, Proprietary Blend: Bovine pancreas PMG extract, dried alfalfa (whole plant) juice, nutritional yeast, porcine duodenum, deflated wheat (gem) , dried buckwheat (leaf) juice and buckwheat (seed). Other Ingredients: Arabic gum and calcium stearate. Standard Process Inc., PO Box 904, Palmyra, WI 59158, UPC 8 12122 01153 2 12.

Standard Process, Inc.

FDA Food Moderate Jul 25, 2012

Truitt Brothers, Pacific Northwest Premium Navy Beans, net weight 15 oz. per metal can. The UPC is 0 82225 24145 1. The product is labeled in parts: "***TRUITT BROTHERS***Pacific Northwest PREMIUM NAVY BEANS***NET WT 15 OZ***INGREDIENTS: NAVY BEANS, WATER, SEA SALT, NATURAL CALCIUM CHLORIDE***TRUITT BROS., INC.***SALEM, OREGON 97308***www.truittbros.com***www.foodalliance.org***".

Truitt Bros., Inc.

FDA Food Moderate Jul 25, 2012

SunOpta, Canadian Harvest Oat Fiber, Oat Fiber 300-33, Manufactured by SunOpta Ingredients, Chelmsford, MA 01824

SunOpta Ingredients Group (Corporate HQ)

FDA Drug Low Jul 25, 2012

HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-1310-58, UPC 3 0603-1310-58 4.

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

FDA Drug Low Jul 25, 2012

Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Care, Morristown, NJ 07962 NDC 0280-8015-24

Bayer Healthcare, LLC

FDA Drug Low Jul 25, 2012

Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured and Distributed by: JHP Pharmaceuticals, LLC Rochester, MI 48307 NDC 42023-116-02

JHP Pharmaceuticals, LLC

FDA Drug Critical Jul 25, 2012

Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartridge Unit with Luer Lock, packaged 10 Carpujects/carton, CII, Rx only, Hospira, Inc., Lake Forest, IL ---- NDC 0409-1258-30

Hospira Inc.

FDA Drug Moderate Jul 25, 2012

Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC industries, Inc. Irving ton, NJ 07111, For: Alaven Pharmaceutical LLC Marietta, GA 30062, NDC 68220-086-30

Meda Pharmaceuticals Inc.

FDA Drug Low Jul 25, 2012

Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct. blister (NDC 0280-8005-16), b)24 ct. blister, Distributed by Bayer Health Care, Morristown, NJ 07962 (NDC 0280-8005-25)

Bayer Healthcare, LLC

FDA Drug Moderate Jul 25, 2012

Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and IM Use, For IV and IC Use after Dilution, Rx Only, American Regent, Inc., Shirely, NY 11967 --NDC 0517-1071-25

Luitpold Pharmaceuticals, Inc.

FDA Drug Low Jul 25, 2012

Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in India by: Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai - 400 030, Distributed by: PACK Pharmaceuticals, LLC, Buffalo Grove, IL 60089, NDC 16571-412-10.

Pack Pharmaceuticals

FDA Devices Moderate Jul 25, 2012

GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.

GE Healthcare, LLC

FDA Devices Moderate Jul 25, 2012

Sarns Modular Perfusion System 9000, 115V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Jul 25, 2012

Etac¿ Ono Walker, Etac¿ Avant Walker, and Etac¿ Salsa Walker. These products are four-wheeled walkers intended as a walking aid for indoor and outdoor use for persons weighing up to 125 KG.

Etac Supply Center Ab

FDA Devices Moderate Jul 25, 2012

Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0) 5.57.97.06.30 http;//www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Court. Allendale NJ 07401-1677 USA +1-201-780-8000 Cestas France 33610. Intended Use: The trials are designed and intended to measure the height of the disc space intra-operatively.

Stryker Spine

FDA Devices Low Jul 25, 2012

SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.

Sigma

FDA Devices Critical Jul 25, 2012

CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. It is not intended for homecare use.

CareFusion 203, Inc.

FDA Devices Moderate Jul 25, 2012

Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecological surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument for grasping, dissecting and/or other manipulation of soft tissue is determined to be appropriate by the surgeon.

Integra Limited

FDA Devices Moderate Jul 25, 2012

Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Jul 25, 2012

Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps. Bipolar Forceps designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures powered by a high frequency generator.

Stingray Surgical Products, LLC

FDA Devices Moderate Jul 25, 2012

LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment

LMA North America Inc

FDA Devices Moderate Jul 25, 2012

OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also inten

GE OEC Medical Systems, Inc

FDA Devices Moderate Jul 25, 2012

Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Jul 25, 2012

Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is intended to add moisture to, and sometime to warm, the breathing gases for administration to a patient.

Teleflex Medical

FDA Devices Moderate Jul 25, 2012

Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Jul 25, 2012

OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures. The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgery technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, wh

GE OEC Medical Systems, Inc

FDA Devices Moderate Jul 25, 2012

Terumo Advanced Perfusion System 1 System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Jul 25, 2012

EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-56130; 500-56140; 500-56150) is a catheter, continuous infusion. it consists of the Intelligent Drug Delivery Catheter (IDDC) and the MicroSonic Device (MSD). It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. All therapeutic agents utilized with the EkoSoni

EKOS Corporation

FDA Devices Moderate Jul 25, 2012

Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Ecl

Varian Medical Systems, Inc. Oncology Systems

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: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2012

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 2012 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.