Medical devices, 2024
Shortlist up to four to read them side by side.
3,394 medical device recalls FDA’s Enforcement Report published in 2024, 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.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS… Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack number… Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall see RES for description Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall See RES Description Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall See RES description Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack… Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall See RES description Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT BUNDLE 16CM, Pack… Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack… Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC DOUBLE LUMEN 16CM, Pack Number… Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline procedure packs containing Shenli syringes, labeled as follows: 1) NEURO ANGIO PACK Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline procedure packs containing Shenli syringes, labeled as follows: NEURO ANGIO PACK, Pack Number… Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline convenience kits, labeled as: 1) PAIN SERVICES CDS , Pack Number CDS985445B Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS981579O Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall FreeStyle Libre 3 Sensors Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2024in FDA’s Enforcement Report12 statesnamed in where it went PublishedSep 4, 2024ClassClass IStatusOngoingWhereCalifornia, Florida, Minnesota, Mississippi, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia, Washington and Wyoming
- Medical device recall Nanoplasty 3D Bunion Correction System Implant Potential issue causing a higher frequency of interference with locking screws and/or inserter rods than anticipated, resulting in screws stripping and/or not… Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNationwide, and Colorado, Florida, Maryland, Michigan, North Carolina, South Carolina, Texas and Virginia named
- Medical device recall Cobra, 3-Plate EMG ET Tube, 6.0mm mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ion Endoluminal System There is a potential that the robotic system’s instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a… Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona and California named
- Medical device recall Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following manner: drilling,… Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2024ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the following manner: drilling,… Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2024ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling,… Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2024ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling,… Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2024ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Stryker iBur 4.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling,… Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2024ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner:… Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2024ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner:… Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2024ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the following manner: drilling,… Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2024ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Stryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in the following manner: drilling,… Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2024ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner: drilling,… Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2024ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific) A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Proteus XR/a, stationary X-Ray System The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CARDIOVIT AT-180 Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportFloridathe one state its words name PublishedSep 4, 2024ClassClass IIStatusOngoingWhereFlorida
- Medical device recall DxI 9000 Access Immunoassay Analyzer When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and… Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Indiana, Kansas, Maine, New Hampshire, New Jersey, Oklahoma, Pennsylvania, Texas and Washington named
- Medical device recall Afinion 2 Analyzer Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, Indiana, Massachusetts, Minnesota and Ohio named
- Medical device recall BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal… Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Illinois, Michigan and Tennessee named
- Medical device recall DR 800. Digital Radiography X-ray System. Potential for the front lever chain of the DR 800 table to fail. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Missouri, North Carolina, New Jersey, Ohio, Oklahoma, South Carolina, Virginia, Wisconsin and West Virginia named
- Medical device recall Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327F Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYKL1025 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline procedural kits labeled as: PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040H Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline procedural kits labeled as: 1) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050Q Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Number DYNJ85516 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline procedural kits labeled as: 1) BIOPSY PACK, Pack Number DYNJ63370A Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline procedural kits labeled as: 1) FETAL SURGERY-LF, Pack Number CDS840214Q Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNo 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.”
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