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 or Centurion medical convenience kits 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 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
Siemens Healthcare Diagnostics, Inc. Dimension Creatinine Flex reagent cartridge recall: Siemens Healthcare Diagnostics is recalling certain lots of Dimension
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential…
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Class I · 6 months ago
Boston Scientific Pacemaker, Implantable Pulse Generator 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
Beta Bionics, Inc. iLet Bionic Pancreas, REF: BB1001 recall: insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous
insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading…
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Class II · 6 months ago
Philips Ingenia 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
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 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 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
Depuy Synthes, Attune Revision Hinge Femoral RT SZ 5 CEM recall: The external sterile packaging was found adhered to the internal sterile
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
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Class II · 6 months ago
Depuy Synthes, Attune Revision Hinge Femoral LT SZ 5 CEM recall: The external sterile packaging was found adhered to the internal sterile
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
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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
Milestone S.R.L. Vacuum BAG SU Large, Non-sterile specimen container, Model/ recall: There is a possibility of reagent leakage from the specimen container
There is a possibility of reagent leakage from the specimen container.
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Class II · 6 months ago
Depuy Synthes, Attune Revision Hinge Femoral LT SZ 8 CEM recall: The external sterile packaging was found adhered to the internal sterile
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
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Class III · 6 months ago
Heraeus, Palamix uno. Material Number: 66057893 recall: Based on long-term stability testing, it was determined that in units older
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose…
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Class II · 6 months ago
Medline and Centurion medical convenience kits 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 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
Philips SmartPath to Ingenia Elition X 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
Medtronic Sphere-9 Catheter recall: Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy
Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik…
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Class II · 6 months ago
Medline and Centurion medical convenience kits 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 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 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 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 I · 6 months ago
WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13 recall: Cyber vulnerability of BLE communication was found by CISA VDP program
Cyber vulnerability of BLE communication was found by CISA VDP program.