Medical devices, 2012
Shortlist up to four to read them side by side.
1,310 medical device recalls FDA’s Enforcement Report published in 2012, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
1,310of 1,310 medical device recallsshown with your filters
The list
- Medical device recall Product is labeled in part: “***MEDLINE***Extended PTFE Needle 6.5” On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Product is labeled in part: “***MEDLINE***Extended PTFE Coated Needle 4.0” On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Product is labeled in part: “***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0” On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Product is labeled in part: “***MEDLINE***Standard PTFE Coated Needle 2.75” On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Product is labeled in part: “***MEDLINE***Staight Microsurgical Needle 3cm On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Product is labeled in part: “***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Product is labeled in part: “***MEDLINE***Extended PTFE Coated Blade 6.5 On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Product is labeled in part: “***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 4.0 On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Product is labeled in part: “***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Product is labeled in part: “***MEDLINE***Standard PTFE Coated Blade with Extended Insulation 2.50 On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Product is labeled in part: “***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 6.5 On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Various SRI Surgical Disposable Accessory Packs Distribution of a product that did not meet specifications. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Kentucky, Maryland, Michigan, North Carolina, New Jersey, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas and Utah named
- Medical device recall DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA… Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the… Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Philips SureSigns VSi/VS2+ patient monitors Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wall mount Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes… The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient’s clinical… Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Ohio named
- Medical device recall Alaris Pump Module The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2012ClassClass IStatusTerminatedWhereNationwide
- Medical device recall syngo Dynamics Version 9.5 If multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time, it is possible for an image from a patient to be placed in… Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Georgia, Iowa, Kentucky, Massachusetts, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Utah, Washington and Wisconsin named
- Medical device recall Altrx” Altralinked” Polyethylene liners Description: An acetabular liner is one of the implants used during… In the recalled lot, the products were not machined according to the production router, a size 52 cup (122136052) was machined instead. Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedAug 29, 2012ClassClass IIStatusTerminatedWherePennsylvania
- Medical device recall GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT X-ray units did not meet manufacturer’s specification for linearity. Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Conformis iTotal CR-Cruciate Retaining Knee Replacement System Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce… 1. Class IIFDA’s classAug 29, 2012in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereIndiana and Ohio
- Medical device recall Oxford Gap Gauge SML 3/4mm A drafting error during an unrelated design change has led to 4 misleading dimensions on the drawing. Class IIFDA’s classAug 29, 2012in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereIndiana, South Dakota and Texas
- Medical device recall UniCel DxH Slidemaker Stainer Instrument System, PN 775222 The recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Floor Stand shipped with Slidemaker Stainer instruments were… Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Illinois, Indiana, Missouri, Mississippi, North Carolina, New York, Pennsylvania, Texas and Washington named
- Medical device recall UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152 The recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Floor Stand shipped with Slidemaker Stainer instruments were… Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Illinois, Indiana, Missouri, Mississippi, North Carolina, New York, Pennsylvania, Texas and Washington named
- Medical device recall Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of… A recall was initiated because Beckman Coulter has identified a negative bias in test results when comparing elevated Total T3 patient samples diluted with… Class IIIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The… Syphilis Assay Interference with HBsAg Assay Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive. Class IIIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Serial interface module RS-232 Product Usage: The System 1 provides perfusion case data transfer through the… Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using… Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Serial interface module RS-485 Product Usage: The System 1 provides perfusion case data transfer through the… Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using… Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Interface module for CDl System 100/101 Product Usage: The Interface Module for CDl 500 is the interface… Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using… Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Interface module for CDl System 500 Product Usage: The Interface Module for CDl 500 is the interface between… Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using… Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall OPTETRAK LOGIC Proximal Tibial Spacer & Screws Exactech, Inc. Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, Colorado, Florida, Georgia, Illinois, Louisiana, Maryland, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Virginia and Washington named
- Medical device recall The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x… The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a “Sterile” logo in the lower right corner. Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical… GE Healthcare had recalled certain OEC InstaTrak 3500 Carts due to the potential for the cart to tip over when the arm of the imaging device is extended during… Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the… Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit incorrectly elevated cardiac troponin I results. Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Horizon Medical Imaging system There is a potential to save reports in RadReport with an Incorrect Final Status. Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16 PET/CT,… Philips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a hole through the casing on one of the batteries. Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Maryland, Minnesota, Nebraska and Pennsylvania named
- Medical device recall 892.1650 Image-intensified fluoroscopic x-ray system GE OEC is recalling certain 9800 Image Intensified Flouroscopic x-ray systems due to customer complaint analysis showing that a replacement Hitachi 160 GB Hard… Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide… GE OEC recalled certain 9800 Fluoroscope & 9900 Elite Models because the Snubber Board did not conform to the IEC 60601-1 standard for clearance and creepage… Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EasyLink Informatic System is included with the Dimension Vista System When using the EasyLink Quality Control Package the system may not perform as intended for Multi-Rule QC violations [e.g., 2(2S), 4(1s) and 10x], unless… Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting. Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than the actual… Class IIIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Medtronic O-arm¿ Imaging System A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn. Class IIFDA’s classAug 29, 2012in FDA’s Enforcement Report8 statesnamed in where it went PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereAlabama, Colorado, Florida, Iowa, Michigan, North Carolina, Nebraska and New York
- Medical device recall The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may… The patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on the foot switch. Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, District of Columbia, Florida, Georgia, Kentucky, Maryland, Michigan, Minnesota, Mississippi, North Dakota, New Mexico, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Vermont, Washington and Wisconsin named
- Medical device recall Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO… Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker… Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Florida, Idaho, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, New Jersey, New York, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO… Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker… Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Florida, Idaho, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, New Jersey, New York, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Powered Mobility Offers Versatility (M¿V)TM Chair Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker… Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Florida, Idaho, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, New Jersey, New York, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Powered Mobility Offers Versatility (M¿V)TM Chair Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker… Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Florida, Idaho, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, New Jersey, New York, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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