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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 3101–3120 of 39,430 recalls

Class IIOngoing

Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system

SEDECAL SA

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.

June 10, 2025 · DeviceView details →
Class IIOngoing

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 various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation / puncture.

Boston Scientific Corporation

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.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system

SEDECAL SA

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.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system

SEDECAL SA

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.

June 10, 2025 · DeviceView details →
Class IIOngoing

SM_40HF_B_D_VIR3.004, Mobile X-ray system

SEDECAL SA

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.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number 40KWFXPLUS.889, Mobile X-ray system

SEDECAL SA

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.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system

SEDECAL SA

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.

June 10, 2025 · DeviceView details →
Class IIOngoing

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 Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added. Component: No, not a component

Ortho-Clinical Diagnostics, Inc.

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).

June 10, 2025 · DeviceView details →
Class IIOngoing

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 Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added. Component: No, not a component

Ortho-Clinical Diagnostics, Inc.

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).

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system

SEDECAL SA

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.

June 10, 2025 · DeviceView details →
Class IIOngoing

SM_40HF_BDC, Mobile X-ray system

SEDECAL SA

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.

June 10, 2025 · DeviceView details →
Class IIOngoing

RADPRO MOBILE, Mobile X-ray system

SEDECAL SA

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.

June 10, 2025 · DeviceView details →
Class IIOngoing

Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)

SEDECAL SA

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.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number 40KWMOBILE3.899, Mobile X-ray system

SEDECAL SA

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.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number 40KWFXPLUS.005, Mobile X-ray system

SEDECAL SA

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.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system

SEDECAL SA

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.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number 40KWFXPLUS.002, Mobile X-ray system

SEDECAL SA

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.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system

SEDECAL SA

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.

June 10, 2025 · DeviceView details →
Class IIOngoing

Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system

SEDECAL SA

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.

June 10, 2025 · DeviceView details →
Class IIOngoing

Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system

SEDECAL SA

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.

June 10, 2025 · DeviceView details →
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