Recalls affecting Kentucky
Notices that name Kentucky in their distribution area, plus every nationwide recall — nationwide recalls reach Kentucky too.
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Class II · 12 months ago
Elekta, Inc. Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage recall: Due to increased risk that paint flakes from the engravings may separate
Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may…
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Class II · 12 months ago
B-K Medical A/S bk3500 Ultrasound System w/battery recall: GE HealthCare has become aware that the Instructions for Use within the user
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery…
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Class II · 12 months ago
Mozarc Medical US LLC Mahurkar" Acute High Pressure Triple Lumen Catheter Tray recall: A potential issue with the seal integrity of header bag packaging
A potential issue with the seal integrity of header bag packaging.
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Class II · 12 months ago
Mozarc Medical US LLC Mahurkar" Acute High Pressure Triple Lumen Catheter Tray recall: A potential issue with the seal integrity of header bag packaging
A potential issue with the seal integrity of header bag packaging.
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Class II · 12 months ago
Spacelabs Healthcare, Ltd. Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/ recall: Due to two distinct issues: 1. During patient admission
Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems…
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Class II · 12 months ago
B-K Medical A/S bk3000 Ultrasound System w/battery recall: GE HealthCare has become aware that the Instructions for Use within the user
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery…
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Class II · 12 months ago
Mozarc Medical US LLC Mahurkar" Acute High Pressure Triple Lumen Catheter Tray Curved recall: A potential issue with the seal integrity of header bag packaging
A potential issue with the seal integrity of header bag packaging.
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Class II · 12 months ago
B-K Medical A/S 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814 recall: GE HealthCare has become aware that the Instructions for Use within the user
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery…
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Class II · 12 months ago
Total Joint Orthopedics, Inc. Brand Name: Klassic BiPolar Head Model/ recall: Potential packaging issue that could compromise the sterile barrier. Defect
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk…
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Class II · 12 months ago
B-K Medical A/S UUltrasound System 2300, bkActiv w/battery recall: GE HealthCare has become aware that the Instructions for Use within the user
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery…
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Class II · 12 months ago
Mozarc Medical US LLC Mahurkar" Acute High Pressure Triple Lumen Catheter Tray Curved recall: A potential issue with the seal integrity of header bag packaging
A potential issue with the seal integrity of header bag packaging.
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Class II · 12 months ago
B-K Medical A/S bk5000 Ultrasound System w/battery recall: GE HealthCare has become aware that the Instructions for Use within the user
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery…
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Class II · 12 months ago
B-K Medical A/S Ultrasound System 1300, bkSpecto w/battery recall: GE HealthCare has become aware that the Instructions for Use within the user
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery…
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Class II · 12 months ago
Mozarc Medical US LLC Mahurkar" Acute High Pressure Triple Lumen Catheter Tray recall: A potential issue with the seal integrity of header bag packaging
A potential issue with the seal integrity of header bag packaging.
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Class I · 12 months ago
Integra LifeSciences Corp. Codman Disposable Perforator 11mm. Cranial Perforator recall: Expansion of recall of size 14 mm Codman Disposable Perforators
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an…
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Class II · 12 months ago
Mozarc Medical US LLC Mahurkar" Acute High Pressure Triple Lumen Catheter Tray Curved recall: A potential issue with the seal integrity of header bag packaging
A potential issue with the seal integrity of header bag packaging.
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Class II · 12 months ago
Prismatik Dentalcraft, Inc. Brand Name: Inclusive Product Name: Inclusive Titanium recall: Incorrect titanium screw, packaged with dental implant
Incorrect titanium screw, packaged with dental implant.
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Class II · 12 months ago
Zydus Pharmaceuticals Inc clomiPramine Hydrochloride, Capsules, USP, 75 mg recall: cGMP deviations: an observed Out of Specification of Nitrosamine Drug
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…
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Class II · 12 months ago
Zydus Pharmaceuticals Inc clomiPramine Hydrochloride, Capsules, USP, 50 mg recall: cGMP deviations: an observed Out of Specification of Nitrosamine Drug
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…
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Class II · 12 months ago
Zydus Pharmaceuticals Inc clomiPramine Hydrochloride, Capsules, USP, 25 mg recall: cGMP deviations: an observed Out of Specification of Nitrosamine Drug
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…
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Class II · 12 months ago
Aero Healthcare Acetaminophen 500mg Caffeine 65mg caplets recall: Labeling: Label Mix-up. This issue affects the outer box labeling only
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine…
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Class II · 12 months ago
Strawberry Cheesecake Ice Cream with graham crackers swirl recall: Foreign material fragments consisting of aluminum foil and packaging material
Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in…
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Class II · 12 months ago
Bakery Graham Pieces, 10 LB Label reads in part as "Ice Cream Factory recall: Foreign material fragments consisting of aluminum foil and packaging material
Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in…
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Class I · 12 months ago
ByHeart Whole Nutrition Infant formula 24 oz cans and 0.6oz packets recall: Potential Foodborne Illness – Clostridium botulinum
Potential Foodborne Illness – Clostridium botulinum