Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-02-12FDA-DevicePhilips North America LlcClass IIIntelliVue Patient Monitor MX550. Model Number: 866066
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
- 2025-02-12FDA-DevicePhilips North America LlcClass IIIntelliVue Patient Monitor MX500. Model Number: 866064
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
- 2025-02-12FDA-DevicePhilips North America LlcClass IIIntelliVue Patient Monitor MX450. Model Number: 866062
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
- 2025-02-12FDA-DevicePhilips North America LlcClass IIIntelliVue Patient Monitor MX400. Model Number: 866060
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
- 2025-02-12FDA-DevicePhilips North America LlcClass IIIntelliBridge EC10 Module. Model Number: 865115
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
- 2025-02-12FDA-DeviceNeilmed Pharmaceuticals IncClass IINeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a saline-based gel formula that can be sprayed to moisturize and lubricate dry and irritated anterior or front of nasal passages caused by dry climate and indoor heat.
Due to nasal spray stability failure for bioburden.
- 2025-02-12FDA-DeviceNew Medical Technologies GmbhClass IIIntegra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.
- 2025-02-12FDA-DeviceNew Medical Technologies GmbhClass IIIntegra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.
- 2025-02-12FDA-DevicePhysio-Control, Inc.Class IILIFEPAK 35 ECG cable REF 11111-000041
Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
- 2025-02-12FDA-DeviceNobel BiocareClass II. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting dental protheses to restore chewing function
Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.
- 2025-02-12FDA-DeviceBelmont Instrument LLCClass IIBelmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids to any patients e10 kg requiring warmed infusion. Part Number:903-00006
Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set
- 2025-02-12FDA-DeviceEthicon, LLCClass IIETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
- 2025-02-12FDA-DeviceEthicon, LLCClass IIPERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures.
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
- 2025-02-12FDA-DeviceEthicon, LLCClass IIPROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
- 2025-02-12FDA-DeviceHologic, Inc.Class IIThe Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party supplier, MML Diagnostics Packaging, and includes the transport tube, cap, and extraction buffer. Tubes are packaged into PN: 71738-00 at Hologic prior to kit release.
Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extraction buffer. The transport tubes are used with the Fetal Fibronectin Enzyme Immunoassay and Rapid fFN¿ for the TLiIQ¿ System which aids in assessing the risk of preterm delivery. The use of empty transport tubes or transport tubes containing insufficient extraction buffer volume may result in invalid results and/or delays in obtaining results. Additionally, the use of underfilled tubes may result in false positive results and the use of overfilled tubes may result in false negative results.
- 2025-02-12FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAzurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- 2025-02-12FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAzurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- 2025-02-12FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAzurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- 2025-02-12FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAzurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- 2025-02-12FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAzurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- 2025-02-12FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAzurion 5 M12 System Code: (1) 722227 (2) 722231
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- 2025-02-12FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAzurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- 2025-02-12FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAzurion 3 M12 System Code: (1) 722063 (2) 722221
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- 2025-02-12FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAlluraXperFD20/15 System Code: (1) 722058
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- 2025-02-12FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAllura Xper FD20/20 System Code: (1) 722038
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- 2025-02-12FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAlluraXperFD20/10 System Code: (1) 722029
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- 2025-02-12FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- 2025-02-12FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- 2025-02-12FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
- 2025-02-12FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
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