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 II · 8 months ago
B Braun Medical Inc Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM recall: The potential for the needle tip to be dull/blunt
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
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Class II · 8 months ago
B Braun Medical Inc Brand Name: B. Braun Product Name: 21GA Winged Infusion recall: The potential for the needle tip to be dull/blunt
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
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Class II · 8 months ago
Datascope Corp. CS100 Iabp. Software Version CS100 Iabp Q.01 recall: The firm has identified that the battery runtime and cycle specifications
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
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Class II · 8 months ago
Siemens Healthcare Diagnostics, Inc. Atellica CH Urine Albumin . Material Number recall: Falsely depressed UAlb patient results may occur. Affected samples with any
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL…
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Class II · 8 months ago
Datascope Corp. CS300 Iabp. Software Version CS300 Iabp C.01 recall: The firm has identified that the battery runtime and cycle specifications
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
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Class II · 8 months ago
GE Healthcare GE Healthcare Centricity Universal Viewer Zero Footprint Client recall: Under certain workflows, patient information shown in the viewer
Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint…
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Class II · 8 months ago
Roche Diagnostics Operations, Inc. cobas pro integrated solutions with cobas c 503 recall: Software defect, which allows the system to accept erroneous
Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is…
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Class II · 8 months ago
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038 recall: A potential weakness has been identified in the probe body
A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the…
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Class II · 8 months ago
Brand Name: Aesculap Product Name: Minop Trocar 150MM 4 Wking recall: There is the potential for the length of the trocar shaft to be too long
There is the potential for the length of the trocar shaft to be too long.
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Class I · 8 months ago
Abiomed, Inc. Impella RP. Product Code: 0046-0011 recall: Differential pressure (dP) sensor in Impella RP devices may malfunction
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
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Class II · 8 months ago
B Braun Medical Inc Brand Name: B. Braun Product Name: 21GA Winged INF SET Model/ recall: The potential for the needle tip to be dull/blunt
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
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Class II · 8 months ago
Olympus Corporation of the Americas Brand Name: ShockPulse-SE Lithotripsy System recall: Ongoing investigations identified additional instances of the device
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer…
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Class I · 8 months ago
Abiomed, Inc. Impella RP with SmartAssist. Product Code: 0046-0035 recall: Differential pressure (dP) sensor in Impella RP devices may malfunction
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
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Class II · 8 months ago
Olympus Single Use Biopsy Valve. Model/ recall: Potential for rubber fragment detachment during use
Potential for rubber fragment detachment during use.
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Class I · 8 months ago
Abiomed, Inc. Impella RP Flex with SmartAssist. Product Code: 1000323 recall: Differential pressure (dP) sensor in Impella RP devices may malfunction
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
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Class II · 8 months ago
Olympus Single use Biopsy Valve. Model/ recall: Potential for rubber fragment detachment during use
Potential for rubber fragment detachment during use.
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Class I · 8 months ago
ANTHONY TRINH, 123Herbals LLC Silintan 25/pills, packaged in a 25-count bottle recall: Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
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Class II · 8 months ago
Acme United Corporation Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe recall: CGMP Deviations
CGMP Deviations
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Class II · 8 months ago
Teva Pharmaceuticals USA, Inc Metoprolol Succinate Extended-Release Tablets recall: Failed Dissolution Specifications
Failed Dissolution Specifications
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Class II · 8 months ago
Acme United Corporation 1) BZK Antiseptic Towelettes 5"x7" Piedmont Sanitizing Hand recall: CGMP Deviations
CGMP Deviations
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Class II · 8 months ago
Acme United Corporation WP WipesPlus Hand Sanitizing Wipes , 5x7, 100 CT recall: CGMP Deviations
CGMP Deviations
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Class II · 8 months ago
Acme United Corporation Cleansing Towelette , 5"x 7", 1,000 case/Bulk recall: CGMP Deviations
CGMP Deviations
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Class II · 8 months ago
Teva Pharmaceuticals USA, Inc Metoprolol Succinate Extended-Release Tablets, 200 mg recall: Failed Dissolution Specifications
Failed Dissolution Specifications
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Class II · 8 months ago
Acme United Corporation Green Guard Antiseptic Wipes , 25 wipes per box recall: CGMP Deviations
CGMP Deviations