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. 2,622 recalls have been distributed to Michigan in the last 12 months.

53,342 total recalls
2,622 in last 12 months

Showing 2078120800 of 53,342 recalls

Medical DeviceNovember 15, 2019· Tytek Medical Inc

Recalled Item: PneumoDart Recalled by Tytek Medical Inc Due to A defect involving an...

The Issue: A defect involving an occluded needle was discovered during a training exercise.

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

Class I — Serious Health HazardOngoing
Medical DeviceNovember 15, 2019· Medtronic Navigation, Inc.-Littleton

Recalled Item: O-arm" O2 Imaging System Recalled by Medtronic Navigation, Inc.-Littleton...

The Issue: Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems,...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 15, 2019· Tosoh Smd Inc

Recalled Item: AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment...

The Issue: The AIA-2000 bar code scanners depend on the quiet zone to help identify the...

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

Class III — Low RiskOngoing
Medical DeviceNovember 15, 2019· Arrow International Inc

Recalled Item: Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J Recalled by...

The Issue: Potential leak in the balloon extension line. If a leak was present and went...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 15, 2019· Arrow International Inc

Recalled Item: Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130 Recalled by...

The Issue: Potential leak in the balloon extension line. If a leak was present and went...

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

Class II — Potential Health HazardOngoing
DrugNovember 14, 2019· AVKARE Inc.

Recalled Item: AVKARE Ranitidine Tablets Recalled by AVKARE Inc. Due to CGMP Deviations:...

The Issue: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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

Class II — Potential Health HazardOngoing
Refund
DrugNovember 14, 2019· AVKARE Inc.

Recalled Item: AVKARE Ranitidine Tablets Recalled by AVKARE Inc. Due to CGMP Deviations:...

The Issue: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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

Class II — Potential Health HazardOngoing
Refund
Medical DeviceNovember 14, 2019· Cardinal Health Inc.

Recalled Item: Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent...

The Issue: Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 14, 2019· Cardinal Health Inc.

Recalled Item: S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent...

The Issue: Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 14, 2019· Cardinal Health Inc.

Recalled Item: Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T....

The Issue: Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents...

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

Class II — Potential Health HazardOngoing
DrugNovember 13, 2019· Precision Dose Inc.

Recalled Item: Ranitidine Oral Solution Recalled by Precision Dose Inc. Due to CGMP...

The Issue: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.

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

Class II — Potential Health HazardOngoing
Refund
DrugNovember 13, 2019· Natures Rx

Recalled Item: Silver Bullet Recalled by Natures Rx Due to Undeclared Active

The Issue: Marketed Without an Approved NDA/ANDA; Product contains undeclared active...

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

Class I — Serious Health HazardOngoing
Refund
Medical DeviceNovember 13, 2019· Linet Spol. S.r.o.

Recalled Item: Eleganza 5 (AC powered adjustable bed) Recalled by Linet Spol. S.r.o. Due to...

The Issue: A component used within the side rail mechanism may malfunction, resulting...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 13, 2019· GETINGE US SALES LLC

Recalled Item: Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion...

The Issue: Sterile barrier system may be compromised

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

Class II — Potential Health HazardOngoing
DrugNovember 12, 2019· QuVa Pharma, Inc.

Recalled Item: fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free...

The Issue: Presence of Particulate matter: manufacturer recalled fentanyl API due to...

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

Class II — Potential Health HazardOngoing
Refund
DrugNovember 12, 2019· QuVa Pharma, Inc.

Recalled Item: fentaNYL 250 mcg/5 mL (50 mcg/mL) Recalled by QuVa Pharma, Inc. Due to...

The Issue: Presence of Particulate matter: manufacturer recalled fentanyl API due to...

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

Class II — Potential Health HazardOngoing
Refund
DrugNovember 12, 2019· QuVa Pharma, Inc.

Recalled Item: fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride Recalled by...

The Issue: Presence of Particulate matter: manufacturer recalled fentanyl API due to...

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

Class II — Potential Health HazardOngoing
Refund
DrugNovember 12, 2019· QuVa Pharma, Inc.

Recalled Item: fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride Recalled by...

The Issue: Presence of Particulate matter: manufacturer recalled fentanyl API due to...

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

Class II — Potential Health HazardOngoing
Refund
DrugNovember 12, 2019· QuVa Pharma, Inc.

Recalled Item: fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe Recalled by QuVa Pharma,...

The Issue: Presence of Particulate matter: manufacturer recalled fentanyl API due to...

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

Class II — Potential Health HazardOngoing
Refund
DrugNovember 12, 2019· QuVa Pharma, Inc.

Recalled Item: fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag Recalled by QuVa Pharma, Inc....

The Issue: Presence of Particulate matter: manufacturer recalled fentanyl API due to...

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

Class II — Potential Health HazardOngoing
Refund