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 7, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Brand Name: GMAX Product Name: SYR 3ML/LL syringe Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: GMAX Product Name: SYR 5ML/LL syringe Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: GMAX Product Name: SYR 6ML/LL syringe Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: GMAX Product Name: SYR 10ML/LL syringe Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: GMAX Product Name: SYR 12ML/LL syringe Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: GMAX Product Name: SYR 20ML/LL syringe Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: GMAX Product Name: SYR 30ML/LL syringe Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: GMAX Product Name: SYR 35ML/LL syringe Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: GMAX Product Name: SYR 60ML/LL syringe Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: GMAX Product Name: SYR 10ML/LS syringe Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: GMAX Product Name: SYR 12ML/LS syringe Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: GMAX Product Name: SYR 20ML/LS syringe Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: GMAX Product Name: SYR 60ML/LS syringe Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: GMAX Product Name: SYR 10ML Control syringe Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: GMAX Product Name: SYR 10ML/LL Blue syringe Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: GMAX Product Name: SYR 60ML/LL Blue syringe Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: GMAX Product Name: SYR 5ML/LL syringe Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE CONTRAST Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE HEP FLUSH Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Brand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). Class IIFDA’s classMay 29, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 29, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Tennessee and Virginia named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Expo 5F Selective Angiographic Catheters An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 22, 2024ClassClass IStatusOngoingWhereNo 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.