Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, 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.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall Brand Name: VITROS Product Name: VITROS 5600 Integrated System The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life… Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life… Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or… Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: N/A Product Name: Repeater Bone Tamp Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C). Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Georgia, Kentucky, Louisiana, Massachusetts, Maryland, Tennessee and Virginia named
- Medical device recall Baxter Solution Set with Duo-Vent Spike Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Massachusetts, Minnesota, Missouri, South Carolina, Texas and Virginia named
- Medical device recall Baxter Clearlink System Solution Set with Duo-Vent Spike Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Massachusetts, Minnesota, Missouri, South Carolina, Texas and Virginia named
- Medical device recall Baxter Continu-Flo Solution Set with Duo-Vent Spike Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Massachusetts, Minnesota, Missouri, South Carolina, Texas and Virginia named
- Medical device recall Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Potential for hole in package compromising sterility of the medical kit. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Maryland, Pennsylvania, Tennessee and Texas named
- Medical device recall Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step… Potential for hole in package compromising sterility of the medical kit. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Maryland, Pennsylvania, Tennessee and Texas named
- Medical device recall Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step… Potential for hole in package compromising sterility of the medical kit. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Maryland, Pennsylvania, Tennessee and Texas named
- Medical device recall Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Potential for hole in package compromising sterility of the medical kit. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Maryland, Pennsylvania, Tennessee and Texas named
- Medical device recall Brand Name: Tacy Medical, Inc Potential for hole in package compromising sterility of the medical kit. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Maryland, Pennsylvania, Tennessee and Texas named
- Medical device recall Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube. If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2025in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJan 22, 2025ClassClass IStatusOngoingWherePennsylvania
- Medical device recall Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube. If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2025in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJan 22, 2025ClassClass IStatusOngoingWherePennsylvania
- Medical device recall Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube. If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2025in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJan 22, 2025ClassClass IStatusOngoingWherePennsylvania
- Medical device recall Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube. If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2025in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJan 22, 2025ClassClass IStatusOngoingWherePennsylvania
- Medical device recall Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809,… Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJan 22, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI… A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 22, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL… A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 22, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI… A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 22, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722) A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 22, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128) A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 22, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228) A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 22, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall Impella RP with SmartAssist Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Impella RP Flex with SmartAssist Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall nuwellis AquaFlexFlow UF 500 Plus The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate “Ultrafiltrate Weight Mismatch” or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IStatusCompletedWhereNationwide
- Medical device recall Cook Medical Biodesign Otologic Butterfly Graft Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereIndiana and Michigan
- Medical device recall Cook Medical Biodesign Hiatal Hernia Graft Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereIndiana and Michigan
- Medical device recall Cook Medical Biodesign Dural Graft Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereIndiana and Michigan
- Medical device recall Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement Report51 statesnamed in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Guam, 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
- Medical device recall Idylla INSTRUMENT, IVD False-positive MSI-H results generated by the Idylla MSI Test. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereAlabama, California, New Jersey, Ohio and Texas
- Medical device recall Karl Storz - Endoskope Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement Report32 statesnamed in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX Red button used to engage side rails can break or become stuck making it difficult to engage the side rail. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereCalifornia, Georgia, Massachusetts and Michigan
- Medical device recall Augustine Surgical Inc HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2025ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Augustine Surgical Inc HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2025ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Hillrom Temperature Management Controller, MP HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2025ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Augustine Surgical Inc HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2025ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Augustine Surgical Inc HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2025ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116,… A possible sterility issue was detected in Coloplast’s facility on some Coloplast products. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124,… A possible sterility issue was detected in Coloplast’s facility on some Coloplast products. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereAlaska, Idaho, Kentucky, Massachusetts, Maryland, Minnesota and Texas
- Medical device recall 8MM, MONOPOLAR CURVED SCISSORS, IS4000 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM, POTTS SCISSORS, IS4000 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM, LARGE NEEDLE DRIVER, IS4000 Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia 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.
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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