Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, 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 7, 2026.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall MCA7-08SD - 0.8MM Diamond Ball, 7.3CM The Anspach Effort, Inc. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MCA7-15SB - 1.5MM Fluted Ball, 7.3CM The Anspach Effort, Inc. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MCA7-15SD - 1.5MM Diamond Ball, 7.3CM The Anspach Effort, Inc. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MCA7-1SB - 1MM Fluted Ball, 7.3CM The Anspach Effort, Inc. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MCA7-1SD - 1MM Diamond Ball, 7.3CM The Anspach Effort, Inc. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MCA7-2SB - 2MM Fluted Ball, 7.3CM The Anspach Effort, Inc. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MCA7-2SD - 2MM Diamond Ball, 7.3CM The Anspach Effort, Inc. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Weck, Electrosurgical Coagulation Suction Tube 6 Sterility cannot be guaranteed. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Weck, Electrosurgical Coagulation Suction Tube 8 Sterility cannot be guaranteed. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV… BD Interlink Threaded Lock Cannula REF# 303369 and lot #3021392 is being recalled due to the potential that a small percentage of the lot may exhibit open… Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Imagecast PACS is an image management system intended to be used by trained professionals, including but not… In Imagecast PACS versions prior to 3.6.51.01, the estimated magnification factor (0018,1114) was not accounted for. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, Connecticut, District of Columbia, Florida, Georgia, Iowa, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk Reports that the product is not performing as expected. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts and Texas named
- Medical device recall Arena-L Trial Handle Handles and heads may not be compatible. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportVirginiathe one state its words name PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereVirginia
- Medical device recall Arena-L 35x26 Trial Head I 10¿ Lordotic Handles and heads may not be compatible. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportVirginiathe one state its words name PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereVirginia
- Medical device recall Arena-L 38x28Trial Head I 10¿ Lordotic Handles and heads may not be compatible. Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportVirginiathe one state its words name PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereVirginia
- Medical device recall Anspach MIA 16 Product did not reach expected sterility assurance level Class IIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedJan 22, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, District of Columbia, Florida, Illinois, Indiana, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Oregon, Pennsylvania, Tennessee, Texas, Utah and West Virginia named
- Medical device recall Carestream DRX-Revolution Mobile X-Ray System It was discovered that Carestream received a report from a customer that 2 different patients were re-exposed due to the fact that the processed images were… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EOS System X- ray beam Digital radiography system used in general radiographic examinations. EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Spectre Wireless Footswitch/Handswitch system TransAmerican Medical Imaging is recalling certain lots of TMI Spectre Wireless Footswitch/Hand switch for GE OEC 9800/9900 and Philips FDS and FDB Cath Labs… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereUtah and Washington
- Medical device recall Puritan Bennett 840 ventilator systems software Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions in response to customer… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2014ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Integra Small Rickham -Style Reservoir Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent or broken connectors that were shipped in sleeve-type package… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, Connecticut, Florida, Minnesota, North Dakota, Nebraska, New Hampshire, New York, Oklahoma, Oregon, Texas, Washington and Wisconsin
- Medical device recall Integra Large Rickham -Style Reservoir Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent or broken connectors that were shipped in sleeve-type packages… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, Connecticut, Florida, Minnesota, North Dakota, Nebraska, New Hampshire, New York, Oklahoma, Oregon, Texas, Washington and Wisconsin
- Medical device recall Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the HiLAN¿ and microspeed motor systems… Certain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possible failure of the handpiece. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNew York, Pennsylvania, Tennessee and Texas
- Medical device recall PedFuse Bone Probe Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereTexas and Virginia
- Medical device recall HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clinical… Positive bias on the lots listed compared to alternate methods and a higher frequency of “Above Assay Range” flags with the lots listed. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical… Positive bias on the lots listed compared to alternate methods and a higher frequency of “Above Assay Range” flags with the lots listed. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall C-Plus” 10mm x 12mm Webless implants Pioneer Surgical’s C-Plus “ 10mm x 12mm Webless implants are cervical… As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Michigan, Missouri and New York named
- Medical device recall REF 42-411571 QTY 1 Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportMissourithe one state its words name PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H… 2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Color Cuff The Color Cuff¿ Sterile Disposable Tourniquet Cuffs with Quick-Connect Fitting may have an incorrect end-connector. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereMichigan, Ohio and Texas
- Medical device recall Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control) Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportMarylandthe one state its words name PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereMaryland
- Medical device recall Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportMarylandthe one state its words name PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereMaryland
- Medical device recall The Propaq LT Series monitors Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 802LTR with software because the fault conditions relating to… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tracer IV wheelchairs, Heavy duty manual wheel chair, 24” seat width, 450 lbs The wheels on Tracer IV wheelchairs (Tracer IV 24” seat width, 450 lbs. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportMichiganthe one state its words name PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereMichigan
- Medical device recall Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 Blade Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, North Carolina, Nebraska, New York, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas and Wisconsin named
- Medical device recall Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, North Carolina, Nebraska, New York, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas and Wisconsin named
- Medical device recall Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #10 Blade Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, North Carolina, Nebraska, New York, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas and Wisconsin named
- Medical device recall Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, North Carolina, Nebraska, New York, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas and Wisconsin named
- Medical device recall Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #15 Blade Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, North Carolina, Nebraska, New York, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas and Wisconsin named
- Medical device recall Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #15 Blade Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, North Carolina, Nebraska, New York, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas and Wisconsin named
- Medical device recall Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# Disposable Safety Handle with #20 Blade Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, North Carolina, Nebraska, New York, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas and Wisconsin named
- Medical device recall Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Reference:… Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Louisiana, Missouri, Mississippi, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 in Reference:… Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Louisiana, Missouri, Mississippi, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference:… Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Louisiana, Missouri, Mississippi, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Louisiana, Missouri, Mississippi, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Louisiana, Missouri, Mississippi, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall On Site Gas Systems POGS 33C Portable Oxygen Generation System Heat exchanger hose becomes weak and may fail. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJan 15, 2014ClassClass IIStatusTerminatedWherePennsylvania
- Medical device recall SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data… GE Healthcare has recently become aware of a potential safety issue which affects all Patient Date Modules produced from April 2007 through June 2010,… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming 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.
Source:
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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