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 0 critical, 46 moderate, and 4 lower-severity recalls. The page references 19 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, 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 Nov 14, 2012

Anatomical Shoulder" Humeral stem

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

MS-30¿ Distal centralizer, cemented, sterile, Rx

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

CLS Stem

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

Kimberly-Clark Corporation

FDA Devices Moderate Nov 14, 2012

Original M.E. Mueller" Low Profile Cup Sterile, Rx

Zimmer, Inc.

FDA Devices Low Nov 14, 2012

Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 2 (List Number 06F12-10; Lot Number 081039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 3 (List Number 06F12-11; Lot Number 091039) Usage: Assayed human plasma which may be used to verify the integrity of newly received i-STAT CK-MB cartridges.

Abbott Point Of Care Inc.

FDA Devices Moderate Nov 14, 2012

Anatomical Shoulder" Humeral Head

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point of care setting

Sendx Medical Inc

FDA Devices Moderate Nov 14, 2012

"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***" Ophthalmic surgery

Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.

FDA Devices Moderate Nov 14, 2012

NCB¿ cancellous screw

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

Kimberly-Clark Corporation

FDA Devices Low Nov 14, 2012

Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

Clinical Diagnostic Solutions

FDA Devices Low Nov 14, 2012

Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

Clinical Diagnostic Solutions

FDA Devices Moderate Nov 14, 2012

Kopf Adapter S Sterile, Rx

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

Fitmore" Hip Stem

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.

Shimadzu Medical Systems

FDA Devices Moderate Nov 14, 2012

Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-7591-7 The Sysmex XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-5000 performs analyses using the following methods: RF/DC Detection Method, Sheath Row DC Detection Method, and Flow Cytometry Methods usi

Sysmex America, Inc.

FDA Devices Moderate Nov 14, 2012

Dynesys¿ HA Pedicle + set screw

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding norm

Philips Medical Systems (Cleveland), Inc.

FDA Devices Moderate Nov 14, 2012

NCB¿-PH Plate

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

Metasul¿ Durom¿ Femoral component Sterile, Rx

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

Dynesys¿ Set screw M6

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

Dynesys¿ Universal spacer 6-45

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512. Usage: Hospital Bed.

Primus Medical LLC

FDA Devices Moderate Nov 14, 2012

STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

Diagnostica Stago, Inc.

FDA Devices Moderate Nov 14, 2012

NCB¿-PT lateral proximal 3 hole tibial plate

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMS Male TO Sling System (Intl). The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI).

American Medical Systems, Inc.

FDA Devices Moderate Nov 14, 2012

TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac Polyaxial Pedicle Screw Syst

Alphatec Spine, Inc.

FDA Devices Moderate Nov 14, 2012

Dynesys¿ L.I.S. Stabilizing cord Rx, Sterile

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

Sirus¿ intramedullary nail for tibia, cannulated ¿

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

Alloclassic¿ SL-Offset Stem sterile, Rx

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures.

Sechrist Industries Inc

FDA Devices Moderate Nov 14, 2012

Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures

Sechrist Industries Inc

FDA Devices Moderate Nov 14, 2012

Wagner SL Revision Stem, uncemented Sterile

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-ray tubes 0.6/1.2P364DK-85, 0.6/1.2P324DK-125, 0.6/1.2P324DK-85, 0.6/1.2P38DE-85 Device Model # R-30H. Subsequent Product Code: IZX Product Usage: The device is the beam-limiting device for X-ray Radiography.

Shimadzu Medical Systems

FDA Devices Moderate Nov 14, 2012

Wagner cone Prosthesis, uncemented, sterile, Rx

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

CoCr Head, sterile, Rx

Zimmer, Inc.

FDA Devices Low Nov 14, 2012

Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma, and EDTA plasma on the Dimension Vista(R) System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Nov 14, 2012

MS-30¿ Proximal positioner

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

Anatomical Shoulder" Fracture Humeral Head

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

Metasul¿ LDH¿ Head Rx Sterile

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

Biolox¿ delta Ceramic Femoral Head Rx only, sterile

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.

Sorin Group USA, Inc.

FDA Devices Moderate Nov 14, 2012

Sunquest Laboratory, version 7.0 not available

Sunquest Information Systems, Inc.

FDA Devices Moderate Nov 14, 2012

Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

MS-30 Shaft, Sterile, Rx

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel. The OrthoPediat

OrthoPediatrics Corp

FDA Devices Moderate Nov 14, 2012

The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is 1815757. Intended as an alternative to traditional alginate materials.

Kerr Corporation

FDA Devices Moderate Nov 14, 2012

Zimmer Inverse/Reverse Screw system,

Zimmer, Inc.

FDA Devices Moderate Nov 14, 2012

Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #983-1341-1 The Sysmex XE-2100 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-2100 performs hematology analyses according to the RF/DC detection method, HydroDynamic Focusing (DC Detection), flow cytometry method (

Sysmex America, 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.