Medical devices, 2015
Shortlist up to four to read them side by side.
2,495 medical device recalls FDA’s Enforcement Report published in 2015, 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.
2,495of 2,495 medical device recallsshown with your filters
The list
- Medical device recall IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 102006720 Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes Class IIFDA’s classJan 14, 2015in FDA’s Enforcement Report25 statesnamed in where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Maryland, Michigan, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, Washington and Wisconsin
- Medical device recall (R)IR remote control JUPITER, Material no.1219656, Serial number: to (incl.) 102317869 Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes Class IIFDA’s classJan 14, 2015in FDA’s Enforcement Report25 statesnamed in where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Maryland, Michigan, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, Washington and Wisconsin
- Medical device recall (R)Cable remote control JUPITER, Material no.1219655, Serial number: to (incl.) 101998119 Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes Class IIFDA’s classJan 14, 2015in FDA’s Enforcement Report25 statesnamed in where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Maryland, Michigan, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, Washington and Wisconsin
- Medical device recall Cable remote control JUX Material, no.1307315, Serial number: to (incl.) 101287649 Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes Class IIFDA’s classJan 14, 2015in FDA’s Enforcement Report25 statesnamed in where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Maryland, Michigan, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, Washington and Wisconsin
- Medical device recall IR remote control JUX, Material no.1307314, Serial number: to (incl.) 102338310 Patient positioning during… Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes Class IIFDA’s classJan 14, 2015in FDA’s Enforcement Report25 statesnamed in where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Maryland, Michigan, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, Washington and Wisconsin
- Medical device recall Cable remote control JUC, BUTTON, Material no.1239823, Serial number: to (incl.) 100143048 Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes Class IIFDA’s classJan 14, 2015in FDA’s Enforcement Report25 statesnamed in where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Maryland, Michigan, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, Washington and Wisconsin
- Medical device recall IR remote control JUC, BUTTON, Material no.1239824, Serial number: to (incl.) 100139854 Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes Class IIFDA’s classJan 14, 2015in FDA’s Enforcement Report25 statesnamed in where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Maryland, Michigan, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, Washington and Wisconsin
- Medical device recall Harmony¿ vLED Surgical Lighting System, one unit STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement Report25 statesnamed in where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah and Virginia
- Medical device recall Synthes Small Electric Drive (SED) The device may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNationwide, and Florida named
- Medical device recall Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform… System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Massachusetts, North Carolina, New York, Pennsylvania and Washington named
- Medical device recall CelluTome Epidermal Harvesting System Harvester KCI has received reports that, in a small number of cases, the CelluTome Harvester (a component of the CelluTome Epidermal Harvesting System), blades have the… Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AlignRT is a video-based three-dimensional Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lumbar Extension Machine for Physical Therapy Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereIdaho, Illinois, Minnesota and Missouri
- Medical device recall Cervical Extension Machine for Physical Therapy Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereIdaho, Illinois, Minnesota and Missouri
- Medical device recall Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle There is the potential for a breach in the inner or outer packaging pouches of all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle There is the potential for a breach in the inner or outer packaging pouches of all lots of the Imbibe Bone Marrow Aspiration Needle. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter’s HomeChoice and HomeChoice Pro… There are additional and updated warning and cautions that are not in the Patient At-Home Guide for HomeChoice Automated PD Systems and HomeChoice PRO… Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000 Intuitive Surgical is initiating a voluntary correction related to da Vinci Si System (IS3000) Vision Side Carts, with threaded-in caster wheels, which can… Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CSA Medical truFreeze System An increase in complaint trending for a loss of audible sound associated with the timer has been observed. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement Report25 statesnamed in where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, North Carolina, New Jersey, New York, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and West Virginia
- Medical device recall Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit) According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Georgia, Indiana, Massachusetts, New York, Pennsylvania and Rhode Island named
- Medical device recall Nerve Block Tray (Nerve Block convenience kit) According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Georgia, Indiana, Massachusetts, New York, Pennsylvania and Rhode Island named
- Medical device recall Diagnostic Imaging Tray (General Surgery convenience kit) According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Georgia, Indiana, Massachusetts, New York, Pennsylvania and Rhode Island named
- Medical device recall Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit) According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Georgia, Indiana, Massachusetts, New York, Pennsylvania and Rhode Island named
- Medical device recall Dimension Vista Myoglobin Calibrator (MYO CAL) Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient test results that exceeds acceptance criteria for this… Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular… Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in… Class IIFDA’s classJan 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 7, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona and Colorado named
- Medical device recall Synthes Inflation System Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in… Class IIFDA’s classJan 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 7, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona and Colorado named
- Medical device recall ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product… Class IIFDA’s classJan 7, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 7, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product… Class IIFDA’s classJan 7, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 7, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ACCU-CHEK¿ Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion and/or injection of… Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the… Class IIFDA’s classJan 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACCU-CHEK Tender I 13/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into… Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the… Class IIFDA’s classJan 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACCU-CHEK Tender I 13/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into… Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the… Class IIFDA’s classJan 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACCU-CHEK Tender I 17/60 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into… Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the… Class IIFDA’s classJan 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into… Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the… Class IIFDA’s classJan 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into… Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the… Class IIFDA’s classJan 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACCU-CHEK Tender II 13/60 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids… Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the… Class IIFDA’s classJan 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACCU-CHEK Tender II 13/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids… Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the… Class IIFDA’s classJan 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids… Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the… Class IIFDA’s classJan 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACCU-CHEK Tender II 17/60 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids… Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the… Class IIFDA’s classJan 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids… Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the… Class IIFDA’s classJan 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACCU-CHEK Tender II 17/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids… Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the… Class IIFDA’s classJan 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cryogenic probe for cardiac ablation surgery Affected product may have compromised sterility due to packaging defects. Class IIFDA’s classJan 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sensei X Robotic Catheter System The Set Up Joint subassembly of the Sensei X Robotic Catheter System may become loose relative to the operating table with the potential for the device to fall… Class IIFDA’s classJan 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hypodermic Needle Pro¿ Edge” Safety Device 20G x1 Needle is not captured in the needle safety sheath in specific lots. Class IIFDA’s classJan 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJan 7, 2015ClassClass IIStatusCompletedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Hypodermic Needle Pro¿ Edge” Safety Device with Syringe 20G x1 10mL Luer lock syringe Needle is not captured in the needle safety sheath in specific lots. Class IIFDA’s classJan 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJan 7, 2015ClassClass IIStatusCompletedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Hypodermic Needle Pro¿ Edge” Safety Device with Syringe 20G x1 5mL Luer lock syringe Needle is not captured in the needle safety sheath in specific lots. Class IIFDA’s classJan 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJan 7, 2015ClassClass IIStatusCompletedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for… Samples of product from Supplier lot 14D0809 and 14D0808 showed little adhesive transfer between the Tyvek lid and cavity when opened for internal bone cement… Class IIFDA’s classJan 7, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 7, 2015ClassClass IIStatusTerminatedWhereCalifornia, Kansas and Michigan
- Medical device recall SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg. Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. Class IIFDA’s classJan 7, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 7, 2015ClassClass IIStatusTerminatedWhereNo state 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.”
Your shortlist0 of 4
Add one more to compare.