Recalls affecting Michigan
Notices that name Michigan in their distribution area, plus every nationwide recall — nationwide recalls reach Michigan too.
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Class II · 12 months ago
Beckman Coulter Inc. Synchron Systems Direct LDL Cholesterol Reagent, REF: 969706 recall: Beckman Coulter has identified that there is an increased probability
Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166…
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Class I · 12 months ago
Tandem Mobi recall: Insulin pump includes a vibration motor that gives tactile feedback for any
Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor…
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Class I · 12 months ago
Integra LifeSciences Corp. Codman Disposable Perforator 9mm. 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
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
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene recall: Zimmer Biomet is conducting a medical device recall for two (2) lots
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is…
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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
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene recall: Zimmer Biomet is conducting a medical device recall for two (2) lots
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is…
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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…