Product Recalls in Michigan

Product recalls affecting Michigan — including food, drugs, consumer products, medical devices, and vehicles distributed to Michigan. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,652 recalls have been distributed to Michigan in the last 12 months.

53,342 total recalls
2,652 in last 12 months

Showing 1578115800 of 53,342 recalls

DrugJuly 14, 2021· Qikmoov LLC

Recalled Item: Vy&Tea (Vietnamese Labeling with a green leaf and a bird Recalled by Qikmoov...

The Issue: Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class I — Serious Health HazardOngoing
Refund
Medical DeviceJuly 14, 2021· Pentax of America Inc

Recalled Item: Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models:...

The Issue: Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceJuly 14, 2021· Pentax of America Inc

Recalled Item: Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One...

The Issue: Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceJuly 14, 2021· Ostial Corporation

Recalled Item: FLASH Ostial System Recalled by Ostial Corporation Due to Angioplasty system...

The Issue: Angioplasty system has a manufacturing issue that has the potential to...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceJuly 14, 2021· Smith & Nephew Orthopaedics Ltd. (Aurora)

Recalled Item: smith&nephew BHR SQUARE HEADED NAIL Recalled by Smith & Nephew Orthopaedics...

The Issue: The nail head may become detached during surgery.

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceJuly 14, 2021· Maquet Medical Systems USA

Recalled Item: Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water...

The Issue: There is the potential for contaminated water to enter parts of the...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceJuly 13, 2021· Micro Therapeutics Inc,

Recalled Item: EV3 Pipeline Flex Embolization Device with Flex Shield Technology Recalled...

The Issue: Due to potential push wire fractures in the delivery system during use. The...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
Medical DeviceJuly 13, 2021· Micro Therapeutics Inc,

Recalled Item: Pipeline Flex Embolization Device Recalled by Micro Therapeutics Inc, Due to...

The Issue: Due to potential push wire fractures in the delivery system during use. The...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
FoodJuly 12, 2021· NOW Health Group Inc.

Recalled Item: Now Real Food Organic Steel Cut Oats Recalled by NOW Health Group Inc. Due...

The Issue: Specific lot of Organic Steel Cut Oats, may actually contain Organic Beet Sugar

Recommended Action: Do not consume. Return to store for a refund or discard.

Class III — Low RiskOngoing
Refund
Medical DeviceJuly 12, 2021· Siemens Medical Solutions USA, Inc.

Recalled Item: ACUSON Juniper Diagnostic Ultrasound System Recalled by Siemens Medical...

The Issue: Due to intermittent failures of the power supply in the ultrasound system...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceJuly 12, 2021· W. L. Gore & Associates Inc.

Recalled Item: Gore Molding & Occlusion Balloon Catheter Recalled by W. L. Gore &...

The Issue: Complaints received concerning Balloon Catheter leakage from the guidewire...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceJuly 12, 2021· Abbott Laboratories, Inc

Recalled Item: Alinity s System . An automated immunoassay analyzer for Recalled by Abbott...

The Issue: A design defect (hardware and software) allows liquid waste pressure to...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceJuly 12, 2021· Stanbio Laboratory, LP

Recalled Item: Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic...

The Issue: Deterioration in the stability of the reagents which has resulted in lower...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskOngoing
Medical DeviceJuly 12, 2021· Stanbio Laboratory, LP

Recalled Item: Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent....

The Issue: Deterioration in the stability of the reagents which has resulted in lower...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskOngoing
Medical DeviceJuly 12, 2021· Stanbio Laboratory, LP

Recalled Item: Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent. Recalled...

The Issue: Deterioration in the stability of the reagents which has resulted in lower...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskOngoing
Medical DeviceJuly 12, 2021· Stanbio Laboratory, LP

Recalled Item: Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent. Recalled by...

The Issue: Deterioration in the stability of the reagents which has resulted in lower...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskOngoing
Medical DeviceJuly 12, 2021· Stanbio Laboratory, LP

Recalled Item: Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in...

The Issue: Deterioration in the stability of the reagents which has resulted in lower...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskOngoing
DrugJuly 9, 2021· Innoveix Pharmaceuticals Inc

Recalled Item: Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or...

The Issue: Lack of Assurance of Sterility

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugJuly 9, 2021· Innoveix Pharmaceuticals Inc

Recalled Item: Compounded Lyophilized AOD-9604 Recalled by Innoveix Pharmaceuticals Inc Due...

The Issue: Lack of Assurance of Sterility

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
Medical DeviceJuly 9, 2021· Copan Italia

Recalled Item: COPAN FLOQSwabs Recalled by Copan Italia Due to A sterility assurance level...

The Issue: A sterility assurance level of 10-6 cannot be guaranteed due to intentional...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing