Recalls affecting Puerto Rico
Notices that name Puerto Rico in their distribution area, plus every nationwide recall — nationwide recalls reach Puerto Rico too.
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Class III · 6 months ago
Heraeus, Palamix duo. Material Number: 66057897 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
Philips Ingenia Ambition S 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
Abbott Point Of Care Inc. i-STAT G3+ cartridge recall: Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number…
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Class II · 6 months ago
Philips Evolution upgrade 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 Industries, LP 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
Depuy Synthes, Attune Revision Hinge Femoral RT 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 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
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 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
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
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
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
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 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 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
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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Class II · 6 months ago
Wells Pharma of Houston LLC fentaNYL Citrate Injectable Solution in 0.9% Sodium recall: cGMP deviations
cGMP deviations.
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Class III · 6 months ago
American Regent, Inc. Levocarnitine Injection, USP, 1 g/5 mL , 5 mL Single-Dose Vial recall: Labeling: Missing Label
Labeling: Missing Label