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 18 critical, 32 moderate, and 0 lower-severity recalls. The page references 29 distinct recalling firms operating in 6 distinct product categories, with 44 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (25), FDA Food (17), NHTSA (6), 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 Oct 17, 2012

IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

Immunodiagnostics Systems Ltd

FDA Devices Moderate Oct 17, 2012

PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate Oct 17, 2012

IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

Immunodiagnostics Systems Ltd

FDA Devices Moderate Oct 17, 2012

Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.

Terumo Cardiovascular Systems Corporation

FDA Devices Critical Oct 17, 2012

Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740, 13768, 13770, 13771, 13772, 13784, 13787. Product Usage: Portable Analgesia Gas Machine.

Accutron Inc

FDA Devices Moderate Oct 17, 2012

3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.

ICU Medical, Inc.

FDA Devices Moderate Oct 17, 2012

OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

Orthohelix Surgical Designs Inc

FDA Devices Moderate Oct 17, 2012

Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Oct 17, 2012

TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A. The Catalog numbers are: 17-00001: TORQ Sternal Closure Device Shipping Carton (6-10 packs), Sterile and, 15-00001 (or 17-00002): TORQ Sternal Closure Device 10-pack - Sterile. The device is supplied double-pouched, inside a shelf box containing 10 devices each. Shelf boxes are shipped to customers in either a small shipping carton containing one (1) shelf box (for a total of 10 devices), or lar

Kardium

FDA Devices Moderate Oct 17, 2012

CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.

Beckman Coulter Inc.

FDA Devices Moderate Oct 17, 2012

Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.

Terumo Cardiovascular Systems Corporation

FDA Devices Critical Oct 17, 2012

Baxter Healthcare Corp.

FDA Devices Moderate Oct 17, 2012

ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate Oct 17, 2012

IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid¿ Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

Immunodiagnostics Systems Ltd

FDA Devices Moderate Oct 17, 2012

3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only.

3M Company - Health Care Business

FDA Devices Moderate Oct 17, 2012

Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 535 Serial No. 535A-104522***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.***KEY FEATURE'S***Infinite

Winco Mfg., LLC

FDA Devices Critical Oct 17, 2012

Ultra PC% Cabinet Mount Package G, Model #36600, Serial # 13593, 13594, 13595, 13596, 13597, 13598, 13599, 13600, 13602, 13605, 13610, 13611, 13612, 13615, 13616, 13617, 13621, 13622, 13624, 13625, 13627, 13628, 13633, 13634, 13635, 13636, 13637, 13638, 13639, 13640, 13642, 13643, 13644, 13647, 13650, 13669, 13675, 13673, 13678, 13679, 13680, 13683, 13685, 13687, 13691, 13693, 13694, 13695, 13696, 13697, 13701, 13702, 13705, 13706, 13709, 13710, 13711, 13724, 13725, 13728, 13729, 13735, 13739,

Accutron Inc

FDA Devices Moderate Oct 17, 2012

Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the A

Beckman Coulter Inc.

FDA Devices Critical Oct 17, 2012

Baxter Healthcare Corp.

FDA Devices Moderate Oct 17, 2012

IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser.

Immunodiagnostics Systems Ltd

FDA Devices Moderate Oct 17, 2012

IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum or plasma on the IDS-iSYS Multi- Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in th

Immunodiagnostics Systems Ltd

FDA Devices Moderate Oct 17, 2012

Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use.

Beckman Coulter Inc.

FDA Devices Moderate Oct 17, 2012

Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilit

Remington Medical Inc.

FDA Devices Moderate Oct 17, 2012

The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. Product Usage: Eon Mini syst

Advanced Neuromodulation Systems Inc.

FDA Devices Moderate Oct 17, 2012

OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

Orthohelix Surgical Designs Inc

NHTSA No agency class Oct 17, 2012

INTERNATIONAL 2013: STEERING

INTERNATIONAL

NHTSA No agency class Oct 17, 2012

BMW 2005-2007: LATCHES/LOCKS/LINKAGES:DOORS:LATCH

BMW

NHTSA No agency class Oct 17, 2012

BMW 2005-2008: POWER TRAIN:AUTOMATIC TRANSMISSION

BMW

NHTSA No agency class Oct 17, 2012

TOYOTA 2007-2012: EQUIPMENT

TOYOTA

CPSC No agency class Oct 16, 2012

Children's Apparel Network Recalls Fleece Hoodie and T-Shirt Sets Due to Violation of Lead Paint Standard; Sold Exclusively at Target

Children's Apparel Network, Ltd. of New York, N.Y.

NHTSA No agency class Oct 16, 2012

HONDA 2012: EQUIPMENT:OTHER:LABELS

HONDA

NHTSA No agency class Oct 12, 2012

KENWORTH 2013: SERVICE BRAKES, AIR:SUPPLY:HOSES, LINES/PIPING, AND FITTINGS

KENWORTH

CPSC No agency class Oct 11, 2012

ElliptiGO Recalls Elliptical Cycles Due to Fall Hazard

ElliptiGO Inc., of Solana Beach, Calif.

FDA Food Critical Oct 10, 2012

VA Kit New Gourmet Fruit Salad 7.75#. Item # 70006, UPC is 0 20728 70006 8. Label reads in part "***VA KIT NEW GOURMET FRUIT SALAD 7.75# *** Ingredients: INGREDIENTS: Watermelon, Honeydew, Cantaloupe, Mangos, Kiwi, Blue Berries. *** Pacific Coast Fruit Portland, OR 97232 ***".

Pacific Coast Fruit Company

FDA Food Moderate Oct 10, 2012

Sadie's Salads Macaroni and Cheese, 5 lb and 10 lb plastic tubs

Sadie's Salads

FDA Food Moderate Oct 10, 2012

Label reads in part "***OCHO RIOS***Spicy***Jerk***Curry***Distributed by :***Ocho Rios International***Miami, Florida 33142***Ingredients: Turmeric,***Fenugreek, Coriander, Cumin***Salt,*** Anise, Pepper, Pimento, Garlic***Degree of "Heat" 4-Hot***"

Ocho Rios-Miami, Inc.

FDA Food Moderate Oct 10, 2012

E-3 Seasoning/Spice, Part #1690. Product is packaged in a white bucket. Net weight 35 lbs. The product is labeled in parts: "***E-3 SEASONING***NET WT 35 LB***Distributed by Boyd Coffee Company, Portland, OR 97230***

Boyd Coffee Co

FDA Food Moderate Oct 10, 2012

Sadie's Salads Macaroni Salad, 5 lb, 10 lb and 30 lb plastic tubs

Sadie's Salads

FDA Food Critical Oct 10, 2012

Wawa mixed fruit with kiwi Net Wt 9.7 oz (275 g) in rigid plastic trays Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191069304

Taylor Farms, Inc.

FDA Food Moderate Oct 10, 2012

Label reads in part "***OCHO RIOS***Mild***Jerk***Curry***Seasoning***Extra delicious!***Distributed by :***Ocho Rios International***Miami, Florida 33142***Ingredients: Turmeric,Allspice***Coriander, Fenugreek, Salt, Pepper,***Cumin, Garlic, Onion, Nutmeg,***Cinnamon, Thyme and spices***Degree of "Heat" 2 Mild"***"

Ocho Rios-Miami, Inc.

FDA Food Critical Oct 10, 2012

Mango Peeled Halved and Cored, wrapped in plastic and refrigerated. Distributed by FreshPoint Central California, Turlock, CA

FreshPoint Central California, Inc.

FDA Food Critical Oct 10, 2012

Sadie's Salads Old Fashioned Cream Slaw, 5 lb, 10 lb and 30 lb plastic tubs

Sadie's Salads

FDA Food Moderate Oct 10, 2012

Sadie's Salads No Sugar Vegetable Pasta Salad, 4 lb and 8 lb plastic tubs

Sadie's Salads

FDA Food Moderate Oct 10, 2012

Sadie's Salads Egg Salad, 5 lb, 10 lb plastic tubs

Sadie's Salads

FDA Food Moderate Oct 10, 2012

Fresh Cuts, Pineapple Dices, 2 oz, Best By: SEP/15/12, Lot Number: 243 and 245.

Henderson's Best Fresh-Cuts, LLC

FDA Food Critical Oct 10, 2012

3/16" Slivered Red Onions, 1/5 lb; 1/4" Slivered Red Onions, 2/5lb, 4/5lb;

Gills Onions, LLC

FDA Food Critical Oct 10, 2012

Mango & Cucumber Salsa item # 71784 UPC 0 20728 71784 4, Best if Used By July 30 to September 2; Label reads in part "***MANGO 7 CUCUMBER SALSA ***Ingredients: Mangos, English Cucumber, Pineapple Vinaigrette: Vinegar (Cider, Distilled), Water, Soybean Oil, High Fructose corn Syrup, Brown Sugar, Honey, Dijon Mustard (Water, Mustard Seed, Vinegar, Salt, White Wine, Citric Acid, Tartaric Acid, Spices), Corn Syrup, Mango Puree, Pineapple Juice Concentrate, Tomato Paste, Sugar, Salt Mustard Flou

Pacific Coast Fruit Company

FDA Food Moderate Oct 10, 2012

Sadie's Salads Egg-N-Olive Salad, 5 lb, 10 lb plastic tubs

Sadie's Salads

FDA Food Critical Oct 10, 2012

Cantaloupes are packed in 6ct, 9ct, 12ct, 15ct, 18ct, cardboard cartons with the DFI Brand. "826 California Westside" is also stamped on outside of the carton. Each cantaloupe also has a DFI brand sticker on it.

Dfi Marketing Inc

FDA Food Critical Oct 10, 2012

Wawa Large mixed fruit Net Wt 12 oz (340 g) in rigid plastic trays Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191069250. Wawa Small mixed fruit Net Wt 7.5 oz (213 g) in rigid plastic trays Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191069243

Taylor Farms, Inc.

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.