PlainRecalls

2012 Recalls

4,173 recalls · Page 40 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 10 critical, 35 moderate, and 5 lower-severity recalls. The page references 28 distinct recalling firms operating in 1 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (50), 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 Sep 26, 2012

CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep

Custom Medical Specialties, Inc.

FDA Devices Moderate Sep 26, 2012

Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically …

Instrumentation Laboratory Co.

FDA Devices Low Sep 26, 2012

0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, …

Amsino Medical USA

FDA Devices Moderate Sep 26, 2012

Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device i…

US Endoscopy Group Inc

FDA Devices Moderate Sep 26, 2012

Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Lab…

Roche Molecular Systems, Inc.

FDA Devices Moderate Sep 26, 2012

Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for i…

Instrumentation Laboratory Co.

FDA Devices Critical Sep 26, 2012

CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contain…

Custom Medical Specialties, Inc.

FDA Devices Moderate Sep 26, 2012

Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications

Philips Healthcare Inc.

FDA Devices Moderate Sep 26, 2012

S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET…

DePuy Orthopaedics, Inc.

FDA Devices Moderate Sep 26, 2012

Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter

Asahi Kasei Medical Co., Ltd., Okatomi Plant

FDA Devices Moderate Sep 26, 2012

Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifically …

Instrumentation Laboratory Co.

FDA Devices Moderate Sep 26, 2012

Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections.

Hospira Inc.

FDA Devices Moderate Sep 26, 2012

HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The HALO Flex Energy Genera…

Covidien LLC

FDA Devices Critical Sep 26, 2012

CMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep

Custom Medical Specialties, Inc.

FDA Devices Moderate Sep 26, 2012

The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme im…

Bio-Rad Laboratories

FDA Devices Moderate Sep 26, 2012

Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. The Bard Ventralight ST Mesh is a dual-component (absorb…

Davol, Inc., Subs. C. R. Bard, Inc.

FDA Devices Critical Sep 26, 2012

CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep

Custom Medical Specialties, Inc.

FDA Devices Moderate Sep 26, 2012

Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes inte…

Kimberly-Clark Corporation

FDA Devices Moderate Sep 26, 2012

Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in…

Instrumentation Laboratory Co.

FDA Devices Moderate Sep 26, 2012

Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring…

Zoe Medical Incorporated

FDA Devices Low Sep 26, 2012

ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 006496…

Siemens Healthcare Diagnostics, Inc

FDA Devices Moderate Sep 26, 2012

MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray syst…

Philips Medical Systems (Cleveland) Inc

FDA Devices Critical Sep 26, 2012

CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used in skin prep

Custom Medical Specialties, Inc.

FDA Devices Low Sep 26, 2012

The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Sep 26, 2012

Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter

Asahi Kasei Medical Co., Ltd., Okatomi Plant

FDA Devices Moderate Sep 26, 2012

The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, …

RAYSEARCH LABORATORIES AB

FDA Devices Moderate Sep 26, 2012

The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a Standard Surf…

Integra Life Sci.

FDA Devices Moderate Sep 26, 2012

STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general surgical table with high patient weight capacity, extended widt…

Steris Corporation

FDA Devices Moderate Sep 26, 2012

Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and St…

Tedan Surgical Innovations Llc

FDA Devices Critical Sep 26, 2012

BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is use…

Custom Medical Specialties, Inc.

FDA Devices Moderate Sep 26, 2012

Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ven…

ZOLL Medical Corporation

FDA Devices Moderate Sep 26, 2012

BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or …

BD Biosciences, Systems & Reagents

FDA Devices Critical Sep 26, 2012

CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage: The PVP contained in the kit is used in skin prep

Custom Medical Specialties, Inc.

FDA Devices Moderate Sep 26, 2012

Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PC…

Spacelabs Healthcare, Llc

FDA Devices Low Sep 26, 2012

Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers.

Impact Instrumentation, Inc.

FDA Devices Moderate Sep 26, 2012

Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter

Asahi Kasei Medical Co., Ltd., Okatomi Plant

FDA Devices Moderate Sep 26, 2012

Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human pl…

Sekisui Diagnostics Llc

FDA Devices Low Sep 26, 2012

ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577 and R…

Siemens Healthcare Diagnostics, Inc

FDA Devices Critical Sep 26, 2012

CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin …

Custom Medical Specialties, Inc.

FDA Devices Moderate Sep 26, 2012

Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended fo…

Kimberly-Clark Corporation

FDA Devices Moderate Sep 26, 2012

Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter

Asahi Kasei Medical Co., Ltd., Okatomi Plant

FDA Devices Moderate Sep 26, 2012

Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagn…

Vascular Solutions, Inc.

FDA Devices Moderate Sep 26, 2012

JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the Jugger…

Biomet, Inc.

FDA Devices Moderate Sep 26, 2012

Precise Digital Accelerator Delivery of radiation to defined target volumes

Elekta, Inc.

FDA Devices Critical Sep 26, 2012

CMS-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep

Custom Medical Specialties, Inc.

FDA Devices Moderate Sep 26, 2012

Verify¿ Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH 44060 The Verify Bowie-Dick Test Card co…

Steris Corporation

FDA Devices Critical Sep 26, 2012

CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage Pack containing 4 oz. bottle PVP Prep Solution Product Us…

Custom Medical Specialties, Inc.

FDA Devices Moderate Sep 26, 2012

Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter

Asahi Kasei Medical Co., Ltd., Okatomi Plant

FDA Devices Moderate Sep 26, 2012

A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. Product Usage: Product provides a flexible, eas…

Steris Corporation

FDA Devices Moderate Sep 26, 2012

Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a dual-component (absorba…

Davol, Inc., Subs. C. R. Bard, 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: 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 July 2026.