Medical Device Recalls
RSS ↗7,959 medical device recalls from federal enforcement feeds.
Showing 751–800 of 7,959
- Class II
Medical Device Recall · March 3, 2026
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouchesThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10C; System Code: 722001;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Class II
Medical Device Recall · March 3, 2026
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch); Box Quantity: 10 poucheThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/10; System Code: 722029;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Class II
Medical Device Recall · March 3, 2026
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); Box Quantity: 5 poucheThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Class II
Medical Device Recall · March 3, 2026
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch); Box Quantity: 5 poucheThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Class II
Medical Device Recall · March 3, 2026
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); Box Quantity: 10;The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20 OR Table; System Code: 722039;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Class II
Medical Device Recall · March 3, 2026
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (Box), H787137097040 (PThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Class II
Medical Device Recall · March 3, 2026
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Class II
Medical Device Recall · March 3, 2026
Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401; Product/UPN No.: H787107314015 (Box), H787107314010 (Pouch); Box Quantity: 5The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ALLURA Xper FD10F; System Code: 722002;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Class II
Medical Device Recall · March 3, 2026
AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM; Catalog No.: 13709804; Product/UPN No.: H787137098045 (Box), H787137098040 (PouThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/15 OR Table; System Code: 722059;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Class II
Medical Device Recall · March 3, 2026
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); Box Quantity: 5 pouchThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Class II
Medical Device Recall · March 3, 2026
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EODue to increased in complaints their is the potential for endoscopic clipping device to malfunction.
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Class II
Medical Device Recall · March 3, 2026
Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 10714024; Product/UPN No.: H787107140245 (Box), H787107140240 (Pouch); Box QuantiThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Class II
Medical Device Recall · March 3, 2026
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box Quantity: 10 pouches;The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Class II
Medical Device Recall · March 3, 2026
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Box), H787137090050 (PouThe affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- Class II
Medical Device Recall · March 2, 2026
Civco Medical Instruments Co. Inc.
eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
- Class I
Medical Device Recall · March 2, 2026
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
- Class II
Medical Device Recall · March 2, 2026
Civco Medical Instruments Co. Inc.
eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
- Class II
Medical Device Recall · March 2, 2026
Civco Medical Instruments Co. Inc.
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
- Class I
Medical Device Recall · March 2, 2026
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
- Class I
Medical Device Recall · March 2, 2026
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
- Class I
Medical Device Recall · March 2, 2026
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
- Class II
Medical Device Recall · March 2, 2026
Civco Medical Instruments Co. Inc.
eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
- Class I
Medical Device Recall · March 2, 2026
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
- Class II
Medical Device Recall · March 2, 2026
Civco Medical Instruments Co. Inc.
eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
- Class II
Medical Device Recall · March 2, 2026
Civco Medical Instruments Co. Inc.
eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
- Class I
Medical Device Recall · March 2, 2026
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
- Class II
Medical Device Recall · March 2, 2026
Civco Medical Instruments Co. Inc.
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
- Class I
Medical Device Recall · March 2, 2026
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
- Class II
Medical Device Recall · March 2, 2026
Civco Medical Instruments Co. Inc.
eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
- Class I
Medical Device Recall · March 2, 2026
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
- Class II
Medical Device Recall · February 27, 2026
Olympus Corporation of the Americas
Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricityFollowing a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
- Class II
Medical Device Recall · February 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B ANGIO PHC DYNJ37485C C.I.C.N. ANGIO PACK DYNJ53064B FHT P NEURO PACK DYUnapproved design changes to the products outside of the 510(k) clearance.
- Class I
Medical Device Recall · February 27, 2026
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. HEAD AND NECK CDS-LF, Medline SKU # CDS780138K;Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- Class I
Medical Device Recall · February 27, 2026
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ANGIO PACK, Medline SKU # DYNJ57032D; 2. NEURO IMedline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- Class II
Medical Device Recall · February 27, 2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF DYNUnapproved design changes to the products outside of the 510(k) clearance.