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 · 4 months ago
INSPIREMD Inc Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/ recall: Stent delivery system may encounter complications during deployment
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
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Class II · 4 months ago
ICU Medical, Inc. Plum Duo Infusion Pump, 40002-0401 recall: Under certain conditions, the pump may not display a soft limit alert
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming…
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Class II · 4 months ago
INSPIREMD Inc CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/ recall: Stent delivery system may encounter complications during deployment
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
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Class II · 4 months ago
AVID Medical, Inc. Halyard, Eye Bag Pack. Kit Code: UIEB48-01 recall: Inadvertent distribution of sealed pouches that had not undergone validated
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
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Class II · 4 months ago
DT MedTech, LLC Hintermann Series Talar Implant, Left, Size 2 REF 302112 recall: Through customer complaints, the ankle replacement system was found
Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right…
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Class II · 4 months ago
Boston Scientific Corporation Orca Single Use Air/Water and Suction Valves recall: Boston Scientific is initiating a medical device removal of Orca Sterile
Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated…
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Class II · 4 months ago
Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG recall: Lidocaine hydrochloride injection, the subject of a supplier recall
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
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Class II · 4 months ago
Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG recall: Lidocaine hydrochloride injection, the subject of a supplier recall
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
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Class II · 4 months ago
Fresenius Medical Care Holdings, Inc. Bicarby" Dialysate recall: Given the increased number of leaks reported by users
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for…
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Class II · 4 months ago
AVID Medical, Inc. Halyard, Drape Pack. Kit Code: LMDP36-01 recall: Inadvertent distribution of sealed pouches that had not undergone validated
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
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Class II · 4 months ago
Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG recall: Lidocaine hydrochloride injection, the subject of a supplier recall
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
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Class II · 4 months ago
Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG recall: Lidocaine hydrochloride injection, the subject of a supplier recall
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
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Class II · 4 months ago
Avanos Medical, Inc. Product Name: Corflo Safety PEG Kit with ENFit Connector Model/ recall: Lidocaine hydrochloride injection, the subject of a supplier recall
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
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Class II · 4 months ago
ICU Medical, Inc. Plum Duo Precision IV Pump, 40002-0403 recall: Under certain conditions, the pump may not display a soft limit alert
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming…
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Class II · 4 months ago
Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG recall: Lidocaine hydrochloride injection, the subject of a supplier recall
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
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Class II · 4 months ago
Avanos Medical, Inc. Brand Name: Corflo Product Name: Corflo* Safety PEG Kit Model/ recall: Lidocaine hydrochloride injection, the subject of a supplier recall
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
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Class II · 4 months ago
Avanos Medical, Inc. Product Name: Corflo* Safety PEG Kit Model/ recall: Lidocaine hydrochloride injection, the subject of a supplier recall
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
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Class II · 4 months ago
HF Acquisition Co LLC Brand Name: Sporetraq Mail-In Spore Testing Service recall: Due to incorrect incubation process being performed on product
Due to incorrect incubation process being performed on product.
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Class II · 4 months ago
GE Medical Systems, LLC Allia IGS 5 Pulse angiographic X-ray system recall: GE HealthCare has become aware of a potential issue affecting an electrical
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue…
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Class II · 4 months ago
Siemens Dimension Tacrolimus Flex Reagent Cartridge , REF DF207 recall: A potential positive bias in quality control (QC) and patient sample results
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
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Class II · 4 months ago
INSPIREMD Inc CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/ recall: Stent delivery system may encounter complications during deployment
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
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Class II · 4 months ago
Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, Nitinol recall: Reusable electrodes may not meet expected performance levels
Reusable electrodes may not meet expected performance levels.
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Class II · 4 months ago
Elekta, Inc. Mosaiq Oncology Information System recall: Software may fail to load adapted baseline shift plan during treatment
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
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Class II · 4 months ago
HF Acquisition Co LLC Brand Name: Sporetraq Mail-In Spore Testing Service recall: Due to incorrect incubation process being performed on product
Due to incorrect incubation process being performed on product.