PlainRecalls

2012 Recalls

4,173 recalls · Page 77 of 84

2012 Recall Year Insight

Federal agencies issued 4,173 product recalls indexed by PlainRecalls in calendar year 2012. That represents about 4.10% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 11.4 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 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 12 critical, 35 moderate, and 3 lower-severity recalls. The page references 26 distinct recalling firms operating in 7 distinct product categories, with 48 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (40), CPSC (7), NHTSA (2), 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, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Critical Jun 27, 2012

GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.

GE Healthcare, LLC

FDA Devices Critical Jun 27, 2012

NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator.

Nidek Medical Products Inc

FDA Devices Moderate Jun 27, 2012

SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG, WITH XCOATING SURFACE COATING. The Sarns High Flow A…

Terumo Cardiovascular Systems Corporation

FDA Devices Critical Jun 27, 2012

NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W. Oxygen Concentrator.

Nidek Medical Products Inc

FDA Devices Moderate Jun 27, 2012

USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and gener…

Non-Invasive Monitoring Systems, Inc.

FDA Devices Moderate Jun 27, 2012

Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The single-use Profile Polypectomy S…

Boston Scientific Corporation

FDA Devices Critical Jun 27, 2012

NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W. Oxygen Concentrator.

Nidek Medical Products Inc

FDA Devices Moderate Jun 27, 2012

Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with FlatDetector with swivel cable Product …

Philips Healthcare Inc.

FDA Devices Critical Jun 27, 2012

NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.

Nidek Medical Products Inc

FDA Devices Moderate Jun 27, 2012

Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00562571 Inner Pouch: M00562570 The single-use Profile Polypectomy Sn…

Boston Scientific Corporation

FDA Devices Moderate Jun 27, 2012

Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system

Philips Healthcare Inc.

FDA Devices Critical Jun 27, 2012

NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator.

Nidek Medical Products Inc

FDA Devices Critical Jun 27, 2012

NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator.

Nidek Medical Products Inc

FDA Devices Moderate Jun 27, 2012

Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satol…

Stryker Howmedica Osteonics Corp.

FDA Devices Critical Jun 27, 2012

NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concentrator.

Nidek Medical Products Inc

FDA Devices Moderate Jun 27, 2012

VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care s…

Accumetrics Inc

FDA Devices Moderate Jun 27, 2012

Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic a…

Covidien LP

FDA Devices Moderate Jun 27, 2012

The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product…

Spacelabs Healthcare, Llc

FDA Devices Moderate Jun 27, 2012

SARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is …

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Jun 27, 2012

Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic an…

Covidien LP

FDA Devices Low Jun 27, 2012

PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipet…

Tripath Imaging, Inc.

FDA Devices Low Jun 27, 2012

PrepStain Installation Kit (PreCoat), Catalog/Model # 490528

Tripath Imaging, Inc.

FDA Devices Critical Jun 27, 2012

NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator.

Nidek Medical Products Inc

FDA Devices Moderate Jun 27, 2012

CPB CATHETER KIT- DR.VAN TRIGHT. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopul…

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Jun 27, 2012

CUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonar…

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Jun 27, 2012

Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic a…

Covidien LP

FDA Devices Moderate Jun 27, 2012

seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients…

Genzyme Corporation

FDA Devices Moderate Jun 27, 2012

HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx …

App Pharmaceuticals Llc

FDA Devices Moderate Jun 27, 2012

HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; an…

App Pharmaceuticals Llc

FDA Devices Moderate Jun 27, 2012

Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system

Philips Healthcare Inc.

FDA Devices Low Jun 27, 2012

Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529

Tripath Imaging, Inc.

FDA Devices Moderate Jun 27, 2012

US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and genera…

Non-Invasive Monitoring Systems, Inc.

FDA Devices Moderate Jun 27, 2012

Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm¿ Imaging System is a m…

Medtronic Navigation, Inc.

FDA Devices Moderate Jun 27, 2012

Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The mult…

Arrow International Inc

FDA Devices Moderate Jun 27, 2012

Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic a…

Covidien LP

FDA Devices Moderate Jun 27, 2012

seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients unde…

Genzyme Corporation

FDA Devices Moderate Jun 27, 2012

Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained withi…

Ultradent Products, Inc.

FDA Devices Moderate Jun 27, 2012

SPECIALTYCARE - HUDGENS. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary b…

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Jun 27, 2012

Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic an…

Covidien LP

FDA Devices Moderate Jun 27, 2012

Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use …

Natus Medical Incorporated

CPSC Moderate Jun 27, 2012

Alltrade Tools Recalls Kawasaki Cordless Drill Due to Burn Hazard; Sold Exclusively at Costco

Wuxi Xinju Electric Tools Co., Ltd. of Wuxi, China

CPSC Moderate Jun 27, 2012

Big Cat Human Powered Vehicles Recalls Bicycle Due to Crash Hazard

Big Cat Human Powered Vehicles LLC, of Winter Garden, Fla.

CPSC Moderate Jun 27, 2012

Samuel Lawrence Furniture Recalls Sleigh Beds Due to Fall Hazard

Poh Huat Furniture Ind., of Malaysia

CPSC Moderate Jun 26, 2012

Servpro Recalls Notus Air Movers Due to Fire Hazard

EDIC, of Los Angeles, Calif.

NHTSA Critical Jun 22, 2012

CHEVROLET 2011-2012: FUEL SYSTEM, GASOLINE:STORAGE:TANK ASSEMBLY:MOUNTING

CHEVROLET

NHTSA Critical Jun 22, 2012

CHEVROLET 2011-2012: ENGINE AND ENGINE COOLING

CHEVROLET

CPSC Moderate Jun 21, 2012

Bluestem Brands and Tone World International Recall Recliner Chair Due to Violation of Lead Paint Standards

Tone World International Inc., of Minneapolis, Minn.

CPSC Moderate Jun 21, 2012

Currie Technologies Recalls Adult Tricycles Due to Fall Hazard

Acetrikes Industrial Co., Ltd., of China

CPSC Moderate Jun 21, 2012

Flushmate Recalls Flushmate® III Pressure-Assisted Flushing System Due to Impact and Laceration Hazards

Flushmate, of New Hudson, Mich., a division of Sloan Valve Company

FDA Food Critical Jun 20, 2012

#1 Gluten Free brand White Cake Mix, 5 lb., UPC 6 54367 43505 2.

Raymond Hadley Corporation

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 - consumer product and vehicle recall feeds for 2012

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Figures cover calendar year 2012 across the FDA, CPSC 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 August 2026.