Medical Device Recalls
RSS ↗7,870 medical device recalls from federal enforcement feeds.
Showing 651–700 of 7,870
- Class II
Medical Device Recall · March 3, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (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
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystemOxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells.
- 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
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;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, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Product/UPN No.: H787107140175 (Box), H787107140170 (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
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;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; 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.
Allura Xper FD20/20; System Code: 722038;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, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10 R/O 6@1CM 4@5CM; Catalog No.: 13709604; Product/UPN No.: H787137096045 (Box),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, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); Box Quantity: 10 units;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, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (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, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (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
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/15; System Code: 722058;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 M12; System Code: (1)722078, (2)722223, (3)722233;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 M12; System Code: (1)722227, (2)722231;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, 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
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, 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, 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, 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
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
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 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 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 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 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 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 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 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 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.