Medical devices, 2016
Shortlist up to four to read them side by side.
3,246 medical device recalls FDA’s Enforcement Report published in 2016, 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.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall Norian Drillable Inject 10 CC-Sterile DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the Norian Drillable Injects-Sterile due to… Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24,… Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry MicroAire discovered that 20 suspect Impactor instruments ( MicroAire Pneumatic Impactor) were shipped to end users and were missing the lock and unlock symbol… Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Video Duodenoscope Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SEAL,IS4000 PORTS,5MM-8MM,BOX of 10 Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJun 8, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10 Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJun 8, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall COSEAL Surgical Sealant Kit, 2 mL Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of… Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall COSEAL Surgical Sealant Kit, 4 mL Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of… Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall COSEAL Surgical Sealant Kit, 8 mL Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of… Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument. One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the… Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur,… Metal shavings released from burs during use are due to contact between the bur and the hood of the PreBent Bur assembly. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Indiana, Maryland, Minnesota, North Carolina, New York, Ohio, Texas, Utah and Virginia named
- Medical device recall AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item During an FDA inspection it was found that the products are marketed without a cleared 510k. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Louisiana, Maryland, Michigan, New Jersey, New York, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide General Purpose… The potential exists within the identified tables that incorrectly manufactured parts have been used in assembly. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Iowa, Louisiana, Massachusetts, Michigan, Mississippi, Pennsylvania, Tennessee, Texas and Wisconsin named
- Medical device recall EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source,… New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised manual cleaning and high level disinfection procedures they plan… Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally… Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect that can possibly result in a patient injury. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement Report28 statesnamed in where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Colorado, Florida, Georgia, Iowa, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Curity Gauze Sponges, 16 ply 4” x 4” Compromised sterility due to breach of barrier Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Kerlix” X-Ray Detectable Laparotomy Sponges, Tray Pack, 16” x 17” Compromised sterility due to breach of barrier Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4” x 4” Compromised sterility due to breach of barrier Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17” x 26” Compromised sterility due to breach of barrier Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Kerlix” X-Ray Detectable Laparotomy Sponges, Tray Pack, 8” x 32” Compromised sterility due to breach of barrier Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18” x 18” Compromised sterility due to breach of barrier Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8” x 36” Compromised sterility due to breach of barrier Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18” x 18” Compromised sterility due to breach of barrier Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12” x 12” Compromised sterility due to breach of barrier Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 4” x 18” Compromised sterility due to breach of barrier Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Curity” X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 8” x 36” Compromised sterility due to breach of barrier Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vistec X-Ray Detectable Sponges, 16 Ply, 8” x 4” Compromised sterility due to breach of barrier Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vistec X-Ray Detectable Sponges, 26 Ply, 8” x 4” Compromised sterility due to breach of barrier Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endoscope; ED-530XT Operation Manual ‘Operation and Preparation’ and ‘Cleaning, Disinfection and Storage’ This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram… Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram… Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram… Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram… Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram… Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma. Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results in patients treated with Fulvestrant. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement Report42 statesnamed in where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments Reports relating to unintended patient or operator burns or operator electric shock for some of Integra’s MicroFrance electrosurgical instruments. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement Report17 statesnamed in where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Florida, Indiana, Kentucky, Massachusetts, Michigan, North Carolina, New Jersey, New Mexico, New York, Ohio, Tennessee, Texas, Washington and Wisconsin
- Medical device recall Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments Reports relating to unintended patient or operator burns or operator electric shock for some of Integra’s MicroFrance electrosurgical instruments. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement Report17 statesnamed in where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Florida, Indiana, Kentucky, Massachusetts, Michigan, North Carolina, New Jersey, New Mexico, New York, Ohio, Tennessee, Texas, Washington and Wisconsin
- Medical device recall Laparotomy Pack These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be… Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide, and Louisiana and Montana named
- Medical device recall Laparotomy Pack Latex Free These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be… Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide, and Louisiana and Montana named
- Medical device recall General Surgery Pack These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be… Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide, and Louisiana and Montana named
- Medical device recall Ergon III Series Skyboom Monitor Bracket Potential for the weld to fail at the pivot point of the monitor bracket. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereGeorgia, Illinois, New Jersey, Utah, Virginia and Vermont
- Medical device recall Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of… The firm became aware of a problem where the system may not map Varian drive after CT user logout/login. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming named
- Medical device recall Ingenuity Core Computed Tomography X-ray Systems, Product Usage: Intended to produce cross-sectional images… The firm became aware of a problem where the system may not map Varian drive after CT user logout/login. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming named
- Medical device recall Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional… The firm became aware of a problem where the system may not map Varian drive after CT user logout/login. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming named
- Medical device recall Ingenuity Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the… The firm became aware of a problem where the system may not map Varian drive after CT user logout/login. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming named
- Medical device recall Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part… Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the expiry date on the product labeling. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement Report12 statesnamed in where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereArkansas, California, Connecticut, Florida, Idaho, Illinois, Indiana, Montana, Ohio, Pennsylvania, Tennessee and Texas
- Medical device recall Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in… Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on the product labeling. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement Report12 statesnamed in where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereArkansas, California, Connecticut, Florida, Idaho, Illinois, Indiana, Montana, Ohio, Pennsylvania, Tennessee and Texas
- Medical device recall Replacement HEPA filter for Natus Sterile-Drier The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement Report18 statesnamed in where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereArizona, California, District of Columbia, Florida, Illinois, Kansas, Massachusetts, Maryland, Minnesota, North Carolina, New Hampshire, New York, Ohio, Oklahoma, Pennsylvania, Virginia, Washington and Wisconsin
- Medical device recall Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with… When DICOM exporting a 3D Monaco plan and the “Composite Field Sequencing” (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should… Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, Nevada, New York, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Virginia, Washington and Wisconsin named
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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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