Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 6 months ago
Medline medical convenience kits, containing Webcol Large Alcohol Prep recall: Medline Industries, LP is issuing a recall for specific item(s) and lot(s)
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads…
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Class I · 6 months ago
Boston Scientific Cardiac Resynchronization Therapy labeled as: 1 recall: Updated software, Brady software maintenance release 6 (SMR6)
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization…
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Class II · 6 months ago
Philips SmartPath to dStream for 3.0T with MR Elastography . 1 recall: The potential for stiffness value errors when a specific range of image
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm…
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Class II · 6 months ago
Hologic, Inc Brand Name: Genius" Review Station Product Name: Genius" Review Station recall: It was identified that certain devices were being operated outside
It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of…
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Class II · 6 months ago
Medline medical procedure kits, containing Medline Neuro Sponges recall: During an internal review, Medline identified higher-than-expected endotoxin
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that…
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Class II · 6 months ago
Medline Neuro Sponges, various dimensions recall: During an internal review, Medline identified higher-than-expected endotoxin
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that…
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Class II · 6 months ago
Becton Dickinson & Co. BD GasPak EZ CO2 Pouch System recall: BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets…
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Elevated risk · 6 months ago
True Metrix Blood Glucose Monitoring Systems recall: As currently written, the Owner’s Booklets/System Instructions for Use fails
As currently written, the Owner’s Booklets/System Instructions for Use fails to emphasize that users must seek medical attention immediately if they…
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Class II · 6 months ago
Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes recall: Potential for the Version 2 reprocessor connecting tube lock levers may fail
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
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Class II · 6 months ago
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate recall: Unapproved design changes to the products outside of the 510(k) clearance
Unapproved design changes to the products outside of the 510(k) clearance.
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Class II · 6 months ago
Medline Kits: 1) Arthrogram Tray recall: The 510(k) regulatory clearances for certain Control Syringes
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
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Class II · 6 months ago
Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator recall: The catheter inflation tag attached to the device may contain an incorrect
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures…
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Class II · 6 months ago
Medline Kits: 1) D AND C PACK recall: The 510(k) regulatory clearances for certain Control Syringes
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
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Class II · 6 months ago
Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Headhunter , Non-Braided recall: The affected devices contain a manufacturing defect which may prevent
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID)…
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Class II · 6 months ago
XTANT Medical Holdings, Inc nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus recall: Products were incorrectly labeled with a 5-year shelf life. The approved
Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
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Class II · 6 months ago
Angiodynamics, Inc. Soft -Vu Angiographic Catheter, Kumpe, Non-Braided recall: The affected devices contain a manufacturing defect which may prevent
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID)…
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Class II · 6 months ago
Angiodynamics, Inc. Soft-Vu Angiographic Catheter, Cobra , Non-Braided recall: The affected devices contain a manufacturing defect which may prevent
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID)…
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Class II · 6 months ago
Remel Europe Ltd. Oxoid Agglutinating Sera, Salmonella 9-0 R30957301 recall: Affected lots are not performing to IFU criteria showing cross reactions
Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the…
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Class II · 6 months ago
Medline Kits: 1) Angio Cath Pack-Mary Immaculat recall: The 510(k) regulatory clearances for certain Control Syringes
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
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Class II · 6 months ago
Sequencing Agent SEQ0067, component of FoundationOne CDx recall: Possible increase in phasing, potentially resulting in false-positive BARD1
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
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Class II · 6 months ago
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate recall: Unapproved design changes to the products outside of the 510(k) clearance
Unapproved design changes to the products outside of the 510(k) clearance.
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Class II · 6 months ago
Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use recall: Due to receiving a notice from a supplier that the liquid adhesive
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
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Class II · 6 months ago
Windstone Medical Packaging, Inc. Custom Convenience Kits Pre Op Kit - NS recall: The product correction was initiated because B Braun is issuing a voluntary
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as…
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Class II · 6 months ago
Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes recall: Potential for the Version 2 reprocessor connecting tube lock levers may fail
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.