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 17 critical, 29 moderate, and 4 lower-severity recalls. The page references 34 distinct recalling firms operating in 7 distinct product categories, with 42 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (17), FDA Food (17), NHTSA (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 Drug Low Dec 5, 2012

Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with Advair HFA actuator only, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0715-20.

GlaxoSmithKline, LLC.

FDA Drug Low Dec 5, 2012

Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709.

GlaxoSmithKline, LLC.

FDA Drug Moderate Dec 5, 2012

Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01

Mylan LLC.

FDA Drug Critical Dec 5, 2012

Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)

Samantha Lynn, Inc

FDA Drug Moderate Dec 5, 2012

Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: a) 63304-829-90, b) 63304-829-05.

Ranbaxy Inc.

FDA Drug Moderate Dec 5, 2012

Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709. Made in England, NDC 0007-4401-06

GlaxoSmithKline, LLC.

FDA Devices Moderate Dec 5, 2012

IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.

Extremity Medical LLC

FDA Devices Moderate Dec 5, 2012

Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, *1059-C, *1058-C, 4000 series, 1100 series, 1060 series, 1080 series, 234 and 246. (* = current production model) All the devices are used in the study and diagnosis of vascular disease and blockages i

Parks Medical Electronics, Inc

FDA Devices Moderate Dec 5, 2012

The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration set. Labeling indicates ~10 ml, Latex-free Infusion Set with Needle-free Port, One injection Port. Device is single use only, do not resterilize, and is available only by prescription. Device made in U.S.A. by Iradimed Corporation located in Winter Park, FL 32792. Lot LBG001, Exp 07/2016 The MRidium MRI Infusion Pumps and Infusion Sets are

Iradimed Corporation

FDA Devices Moderate Dec 5, 2012

Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy

Cooper Surgical, Inc.

FDA Devices Moderate Dec 5, 2012

220/240V AC, Advanced Perfusion System Platform (APS) 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 Dec 5, 2012

The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical procedures. The device is reusable and requires sterilization according to product labeling. .

Medtronic Navigation, Inc.

FDA Devices Moderate Dec 5, 2012

GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).

GE Healthcare, LLC

FDA Devices Moderate Dec 5, 2012

100/120V AC, Advanced Perfusion System Platform (APS) 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 Dec 5, 2012

GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).

GE Healthcare, LLC

FDA Devices Moderate Dec 5, 2012

The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA units (EU) per ml determined by comparison to a Calibrator.

Diamedix Corporation

FDA Devices Moderate Dec 5, 2012

GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).

GE Healthcare, LLC

FDA Devices Moderate Dec 5, 2012

NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen¿¿ system is a semiconstrained, nonlinked condylar knee prostheses. The device is indicated for patients with severe knee pain and disability due to rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; collagen disorders and/or avascular necrosis of the femoral condyle; post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction or prior patellecto

Zimmer, Inc.

FDA Devices Moderate Dec 5, 2012

Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy

Cooper Surgical, Inc.

FDA Devices Moderate Dec 5, 2012

Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction offunctional deformity, 4) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques, 5) revision of previously failed total arthoplasty.

Biomet, Inc.

FDA Devices Moderate Dec 5, 2012

Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.

Kimberly-Clark Corporation

FDA Devices Moderate Dec 5, 2012

Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter.

Metrex Research, LLC.

FDA Devices Critical Dec 5, 2012

Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturers package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain manag

First Medical Source LLC

CPSC No agency class Dec 4, 2012

Gas Fireplace Inserts Recalled by Jotul North America Due to Electrical Shock and Burn Hazards

Jotul North America, of Gorham, Maine

CPSC No agency class Dec 4, 2012

Home Depot Recalls Homer's All-Purpose Bucket Mug Due to Fire Hazard

Mr. Christmas Ltd., of Hong Kong

NHTSA No agency class Dec 4, 2012

DODGE 2013: SEATS

DODGE

NHTSA No agency class Dec 3, 2012

FORD 2011: EQUIPMENT:ELECTRICAL

FORD

NHTSA No agency class Dec 3, 2012

PORSCHE 2010: SUSPENSION:REAR:AXLE:SPINDLE

PORSCHE

NHTSA No agency class Dec 3, 2012

MERCEDES-BENZ 2011-2012: FUEL SYSTEM, GASOLINE

MERCEDES-BENZ

NHTSA No agency class Dec 3, 2012

BMW 2013: STRUCTURE:BODY

BMW

NHTSA No agency class Dec 3, 2012

FORD 2013: ENGINE AND ENGINE COOLING

FORD

NHTSA No agency class Nov 30, 2012

FORD 2013: EXTERIOR LIGHTING:HEADLIGHTS

FORD

NHTSA No agency class Nov 29, 2012

FREIGHTLINER 2013: ELECTRICAL SYSTEM

FREIGHTLINER

FDA Food Low Nov 28, 2012

"***Avena de Aqu¿ Si Azucar A¿adida****8oz****Fabricado por Postres de Aqui, Inc. Calle B Parrio Plamas Cata¿o PR 00962***"

Postres de Aqui, Inc.

FDA Food Critical Nov 28, 2012

Organic Peanut Butter, Item Number 342-007, Pack size 12/14oz tubs. No UPC code. Product labeling:" ".

Torn & Glasser Inc.

FDA Food Low Nov 28, 2012

Swanson Organic, 100% Certified Organic Fennel Seed, Net Wt 6 oz (45 grams), SWF092, UPC 0 87614 24092 3.

Swanson Health Products, Inc

FDA Food Moderate Nov 28, 2012

Rudi's Organic Bakery, Colorado Cracked Wheat, 22 oz, UPC 031493-54373-6, packed in flexible plastic bags. Labeling is tan, yellow, white, maroon, and orange with white, black, green, maroon, and orange print writing.

Charter Baking Company

FDA Food Critical Nov 28, 2012

Smoked Gouda packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.

Sartori Inspirations, LLC

FDA Food Moderate Nov 28, 2012

Famous Thick Salsa packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.

Sartori Inspirations, LLC

FDA Food Critical Nov 28, 2012

Gilster-Mary Lee Corporation, Better Valu Fruit Whirls, Naturally Flavored packaged in a 28 oz (1 LB 12 OZ) (794g) plastic bag. (manufactured by Gilster Mary Lee, Joplin, MO)

Gilster-Mary Lee Corp.

FDA Food Critical Nov 28, 2012

Spinach Feta Dip packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.

Sartori Inspirations, LLC

FDA Food Moderate Nov 28, 2012

"Titan Gelatinas***Postres de gelatina (Gelatin Dessert)***Sabor a China (Orange flavored)***Sabor a Fresa (Strawberry flavored)"

Postres de Aqui, Inc.

FDA Food Moderate Nov 28, 2012

Salsa Cream Cheese packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.

Sartori Inspirations, LLC

FDA Food Critical Nov 28, 2012

Grape Tomatoes, 199 cartons x 12 packages x 1 pint.

E.D. Produce

FDA Food Moderate Nov 28, 2012

Tub labeled as Kay's Classic Vanilla Bean ice Cream. UPC 87848-13021, 1.5 Quarts (1.42L). Lid labeled as Kay's Classic Toasted Butter Pecan ice cream

Schoep's Ice Cream Co, Inc

FDA Food Moderate Nov 28, 2012

Beagle Bay Organics Brand Raw Sauerkraut, Kimchi Net. Wt. 16 oz (416g). Product is stored/distributed under refrigeration and is intended to be eaten raw as a condiment. Beagle Bay Organics, 4501 Manatee Ave W # 105, Bradenton, FL 34209

Cracker Industries, LLC

FDA Food Critical Nov 28, 2012

Pimento Cheese packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.

Sartori Inspirations, LLC

FDA Food Moderate Nov 28, 2012

Rudi's Organic Bakery, Cinnamon Raisin, 24 oz, UPC 031493-92183-1, packed in flexible plastic bags. Labeling is tan, yellow, white, blue, maroon, and orange with white, black, green, maroon, and orange print writing.

Charter Baking Company

FDA Food Moderate Nov 28, 2012

Rudi's Organic Bakery, Multigrain Oat Bread, 22 oz, UPC 031493-82888-8, packed in flexible plastic bags. Labeling is tan, yellow, white, maroon, and orange with maroon, green, black, white, and orange print writing.

Charter Baking Company

FDA Food Critical Nov 28, 2012

Kalamata Tapenade packaged in 7 oz clear plastic and 5 lb white plastic capacity containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.

Sartori Inspirations, LLC

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.