Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 3,751–3,800 of 8,689
- Class II
Medical Device Recall · June 10, 2025
VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in Japan only.Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
- Class II
Medical Device Recall · June 10, 2025
Model Number 40KWFXPLUS.004, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J Used for the percutaneous introduction of variousPotential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number 40KWFXPLUS, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Used for the percutaneous introduction of various types of cardioPotential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
SM_40HF_BDC, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number 40KWFXPLUS-710CW, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number 40KWFXPLUS.005, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
SED URS LP, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number 40KWFXPLUS.002, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).
- Class II
Medical Device Recall · June 10, 2025
Model Number 40KWFXPLUS-710CW.007, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number 40KWFXPLUS.889, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
BostonSight SCLERAL LensSelect orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
- Class II
Medical Device Recall · June 10, 2025
VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VXSK0102 VXSK (180J RF WIRE 63CM/55DEG/D0) VXSK0103Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: VITROS Chemistry ProdQuality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).
- Class II
Medical Device Recall · June 10, 2025
Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: VITROS CheQuality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).
- Class II
Medical Device Recall · June 10, 2025
Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
SM_40HF_BDC3, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
SHIMADZU RF.004, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 6, 2025
Boston Scientific Neuromodulation Corporation
Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 Superion IndiAs a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.
- Class III
Medical Device Recall · June 6, 2025
Akreos, SKU: AO60P0300. Akreos intraocular lensesAn off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acuity which could result in the need for optical or surgical correction.
- Class II
Medical Device Recall · June 5, 2025
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275BHigh pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
- Class II
Medical Device Recall · June 5, 2025
Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825APHigh pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
- Class II
Medical Device Recall · June 5, 2025
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
- Class II
Medical Device Recall · June 5, 2025
High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/CHigh pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.