Medical devices, 2023
Shortlist up to four to read them side by side.
2,477 medical device recalls FDA’s Enforcement Report published in 2023, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically… During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues. Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Philips DreamStation Auto BiPAP and CPAP A limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management application. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6 Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System Some batches of product were not sterilized to their minimum sterilization specification. Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System Some batches of product were not sterilized to their minimum sterilization specification. Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System Some batches of product were not sterilized to their minimum sterilization specification. Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system… Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the… Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the… Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the… Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the… Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the… Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the… Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CAPIOX RX15 Hollow Fiber Oxygenator Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CAPIOX NX19 Hollow Fiber Oxygenator Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CAPIOX FX25 Hollow Fiber Oxygenator Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer,… It has come to CooperSurgical’s attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not… Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 12, 2023ClassClass IIStatusOngoingWhereNationwide, and New York and Utah named
- Medical device recall Abbott Alinity m System The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedApr 12, 2023ClassClass IIStatusOngoingWherePennsylvania
- Medical device recall Neodent GM X 6mm Engaging Titanium Base Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the… Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 5, 2023ClassClass IIStatusOngoingWhereNationwide, and New York, Oregon, Texas and Utah named
- Medical device recall CRP Immunoturbidimetric reagent The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Class IIFDA’s classApr 5, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereOhio, Pennsylvania and West Virginia
- Medical device recall GaGa Pro Lighting Equipment Co GAGA Pro LLS systems was not in compliance with the FDA’s Performance Standard for laser products. Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03… Sterility; Steril surgical procedure packs contain incomplete seals. Class IIFDA’s classApr 5, 2023in FDA’s Enforcement Report14 statesnamed in where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, California, Iowa, Idaho, Indiana, Kentucky, Minnesota, North Carolina, North Dakota, New Jersey, Ohio, Pennsylvania and Texas
- Medical device recall Cirq Arm System 2.0 Risk of mechanical instability due to potential manufacturing error of the device Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportTexasthe one state its words name PublishedApr 5, 2023ClassClass IIStatusOngoingWhereTexas
- Medical device recall da Vinci Xi Surgical System Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within… Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 5, 2023ClassClass IIStatusOngoingWherePuerto Rico
- Medical device recall CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in… Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon… Class IIFDA’s classApr 5, 2023in FDA’s Enforcement Report9 statesnamed in where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereAlabama, Arizona, Colorado, Florida, Louisiana, Michigan, Ohio, Oklahoma and Texas
- Medical device recall PCRopsis BCSNano Presence of misleading label statements on the product label. Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PCRopsis Reagent Buccal, IVD Presence of misleading label statements on the product label. Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PCRopsis Activator: a) 1.5mL Presence of misleading label statements on the product label. Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PCRopsis Lysis Beads, IVDD: a) 25 tubes Presence of misleading label statements on the product label. Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY Presence of misleading label statements on the product label. Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PCRopsis Reagent RVD-RT, IVD: a) 1 mL Presence of misleading label statements on the product label. Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PCRopsis Support: a) 1 mL Presence of misleading label statements on the product label. Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atrium Pneumostat Chest Drain Valve The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against… Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Express Mini 500 Dry Seal Chest Drain The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against… Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation… Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation… Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for… Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereNationwide
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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