Medical device recalls
38845 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2026-02-18FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIStop using affected Philips Azurion 5 M20 systems
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- 2026-02-18FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIStop using affected Philips Azurion 5 M12 systems
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- 2026-02-18FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIStop using affected Philips Azurion 7 M20 systems
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- 2026-02-18FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIStop using affected Philips Azurion 7 M12 systems
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- 2026-02-18FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIStop using affected Philips Azurion 7 B20 systems
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- 2026-02-18FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIStop using affected Philips Azurion 7 B12 systems
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- 2026-02-18FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIStop using affected Philips Azurion 3 M15 systems
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- 2026-02-18FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIStop using affected Philips Azurion 3 M12 systems
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- 2026-02-18FDA-DeviceAlphatec Spine, Inc.Class IIStop using Alphatec Spine navigation osteotome
Due a design issue where the navigated array connection geometry is incorrect.
- 2026-02-18FDA-DeviceAlphatec Spine, Inc.Class IIStop using Alphatec ATEC Navigation Osteotome instruments
Due a design issue where the navigated array connection geometry is incorrect.
- 2026-02-18FDA-DeviceLaerdal Medical CorporationClass IIContact Laerdal about your suction unit
units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.
- 2026-02-18FDA-DeviceElekta, Inc.Class IIContact Elekta about Leksell GammaPlan software update
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
- 2026-02-18FDA-DeviceElekta, Inc.Class IICheck Elekta Leksell GammaPlan treatment plans
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
- 2026-02-18FDA-DeviceAVID Medical, Inc.Class IIStop using Halyard TRANSPORT BAG KIT
Tyvek bag seal issue which may compromise sterility of the kit.
- 2026-02-18FDA-DeviceStraumann USA LLCClass IIICheck your Straumann impression post kit
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
- 2026-02-18FDA-DeviceMedline Industries, LPClass IIStop using Medline Mercy Circumcision Tray kits
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
- 2026-02-18FDA-DeviceMedline Industries, LPClass IIStop using Medline sterile resuture kits (DYNDL1980A)
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
- 2026-02-18FDA-DeviceMedline Industries, LPClass IICheck your Medline dressing change kits for seal damage
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
- 2026-02-18FDA-DeviceMedline Industries, LPClass IIStop using Medline blood culture kits (SKU DYNDH2088)
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
- 2026-02-18FDA-DeviceMedline Industries, LPClass IIStop using Medline suture removal kit DYNDR1277A
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
- 2026-02-18FDA-DeviceMedline Industries, LPClass IICheck your Medline dressing change or central line kit
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
- 2026-02-18FDA-DeviceMedline Industries, LPClass IICheck your Medline medical kit lot numbers
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
- 2026-02-18FDA-DeviceMedline Industries, LPClass IICheck your Medline medical kits for recall
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
- 2026-02-18FDA-DeviceMedline Industries, LPClass IICheck Medline catheter kits for open applicator packaging
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
- 2026-02-18FDA-DeviceMedline Industries, LPClass IICheck your Medline catheter securement kit
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
- 2026-02-18FDA-DeviceMedline Industries, LPClass IICheck Medline Anesthesia Artline Pack kits
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
- 2026-02-18FDA-DeviceMedline Industries, LPClass IStop using affected ACUSON AcuNav catheters immediately
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
- 2026-02-18FDA-DeviceMedline Industries, LPClass IStop using affected SOUNDSTAR eco diagnostic catheters
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
- 2026-02-18FDA-DeviceMedline Industries, LPClass IStop using Medline ReNewal ViewFlex Xtra ICE Catheters
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
- 2026-02-18FDA-DeviceMedline Industries, LPClass IStop using affected St. Jude Supreme catheters
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
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