PlainRecalls

2012 Recalls

4,173 recalls · Page 69 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 6 critical, 44 moderate, and 0 lower-severity recalls. The page references 23 distinct recalling firms operating in 3 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (48), CPSC (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 Moderate Jul 18, 2012

Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820. …

PSC Industries Inc

FDA Devices Critical Jul 18, 2012

Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and …

Alere San Diego, Inc.

FDA Devices Moderate Jul 18, 2012

Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5060-21US, KKB5062-21US …

Arjo, Inc. dba ArjoHuntleigh

FDA Devices Moderate Jul 18, 2012

The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is an accessory used in conjunc…

GE OEC Medical Systems, Inc

FDA Devices Moderate Jul 18, 2012

Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of t…

PSC Industries Inc

FDA Devices Moderate Jul 18, 2012

Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Numb…

PSC Industries Inc

FDA Devices Moderate Jul 18, 2012

Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of chronic intractable pain of the trunk…

Advanced Neuromodulation Systems Inc.

FDA Devices Moderate Jul 18, 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 fo…

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Jul 18, 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 fo…

Terumo Cardiovascular Systems Corporation

FDA Devices Critical Jul 18, 2012

Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or …

Alere San Diego, Inc.

FDA Devices Moderate Jul 18, 2012

i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocr…

Abbott Point Of Care Inc.

FDA Devices Critical Jul 18, 2012

Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in EDTA ant…

Alere San Diego, Inc.

FDA Devices Moderate Jul 18, 2012

Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle) , Stainless Steel / Silicone Rubber, Rx only, non sterile. Produc…

Zimmer, Inc.

FDA Devices Moderate Jul 18, 2012

Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device i…

PSC Industries Inc

FDA Devices Moderate Jul 18, 2012

i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540

Abbott Point Of Care Inc.

FDA Devices Moderate Jul 18, 2012

Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE¿ 3 Blood and Flu…

Smiths Medical ASD, Inc.

FDA Devices Critical Jul 18, 2012

FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no…

Maquet Cardiovascular Us Sales, Llc

FDA Devices Moderate Jul 18, 2012

Monaco Product Usage: Planning of radiation therapy

Elekta, Inc.

FDA Devices Moderate Jul 18, 2012

Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, M…

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Jul 18, 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 f…

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Jul 18, 2012

enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). …

Vital Signs Devices, a GE Healthcare Company

FDA Devices Moderate Jul 18, 2012

Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical…

PSC Industries Inc

FDA Devices Moderate Jul 18, 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 th…

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Jul 18, 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 fo…

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Jul 18, 2012

Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized…

Abbott Point Of Care Inc.

FDA Devices Moderate Jul 18, 2012

Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stry…

Stryker Endoscopy

FDA Devices Moderate Jul 18, 2012

Drager PT 4000 Phototherapy System

Draeger Medical Systems, Inc.

FDA Devices Moderate Jul 18, 2012

i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium…

Abbott Point Of Care Inc.

FDA Devices Moderate Jul 18, 2012

Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic …

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jul 18, 2012

Terumo Advanced Perfusion System 1 System 1 Base, 220/240 V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on t…

Terumo Cardiovascular Systems Corporation

FDA Devices Critical Jul 18, 2012

InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The syst…

GE OEC Medical Systems, Inc

FDA Devices Critical Jul 18, 2012

Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred t…

Alere San Diego, Inc.

FDA Devices Moderate Jul 18, 2012

superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the …

superDimension, Inc

FDA Devices Moderate Jul 18, 2012

Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte.…

Argon Medical Devices, Inc

FDA Devices Moderate Jul 18, 2012

CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or…

Civco Medical Instruments Inc

FDA Devices Moderate Jul 18, 2012

Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B-3930 Hamont-Achel, Belgium; Models HEP0001-US an…

Arjo, Inc. dba ArjoHuntleigh

FDA Devices Moderate Jul 18, 2012

Central Control Module for System 1: System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the …

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Jul 18, 2012

Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infan…

Atom Medical Corporation

FDA Devices Moderate Jul 18, 2012

Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to…

Edwards Lifesciences, LLC

FDA Devices Moderate Jul 18, 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 fo…

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Jul 18, 2012

iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, …

Abbott Point Of Care Inc.

FDA Devices Moderate Jul 18, 2012

CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor, for use with 3D Guidance medSAFE trackers, Ref. 610-1067. …

Civco Medical Instruments Inc

FDA Devices Moderate Jul 18, 2012

CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX instrument…

Civco Medical Instruments Inc

FDA Devices Moderate Jul 18, 2012

Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment o…

Integra LifeSciences Corp

FDA Devices Moderate Jul 18, 2012

Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5022-21US and KKB5042-21…

Arjo, Inc. dba ArjoHuntleigh

FDA Devices Moderate Jul 18, 2012

System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood …

Terumo Cardiovascular Systems Corporation

FDA Devices Moderate Jul 18, 2012

Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and cli…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jul 18, 2012

Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is pa…

PSC Industries Inc

CPSC Moderate Jul 18, 2012

Samuel Lawrence Furniture Expands Recall of Sleigh Beds Due to Fall Hazard

Poh Huat Furniture Ind., of Malaysia

CPSC Moderate Jul 18, 2012

Trampolines Recalled by Panline USA Due to Fall Hazard

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.