Product Recalls in Maine

Product recalls affecting Maine — including food, drugs, consumer products, medical devices, and vehicles distributed to Maine. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,546 recalls have been distributed to Maine in the last 12 months.

48,770 total recalls
2,546 in last 12 months

Showing 41014120 of 48,770 recalls

Medical DeviceSeptember 26, 2024· King Systems Corp. dba Ambu, Inc.

Recalled Item: AMBU / KING LTSD Recalled by King Systems Corp. dba Ambu, Inc. Due to Exceed...

The Issue: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 26, 2024· King Systems Corp. dba Ambu, Inc.

Recalled Item: KING LTSD Recalled by King Systems Corp. dba Ambu, Inc. Due to Exceed the...

The Issue: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 26, 2024· King Systems Corp. dba Ambu, Inc.

Recalled Item: KING LTSD Recalled by King Systems Corp. dba Ambu, Inc. Due to Exceed the...

The Issue: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 26, 2024· King Systems Corp. dba Ambu, Inc.

Recalled Item: KING LTSD Recalled by King Systems Corp. dba Ambu, Inc. Due to Exceed the...

The Issue: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 26, 2024· King Systems Corp. dba Ambu, Inc.

Recalled Item: KING LTSD Recalled by King Systems Corp. dba Ambu, Inc. Due to Exceed the...

The Issue: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 26, 2024· King Systems Corp. dba Ambu, Inc.

Recalled Item: KING LTSD Recalled by King Systems Corp. dba Ambu, Inc. Due to Exceed the...

The Issue: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 26, 2024· King Systems Corp. dba Ambu, Inc.

Recalled Item: KING LTSD Recalled by King Systems Corp. dba Ambu, Inc. Due to Exceed the...

The Issue: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 26, 2024· King Systems Corp. dba Ambu, Inc.

Recalled Item: KING LTSD Recalled by King Systems Corp. dba Ambu, Inc. Due to Exceed the...

The Issue: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because...

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

Class II — Potential Health HazardOngoing
DrugSeptember 25, 2024· Fresenius Kabi Compounding, LLC

Recalled Item: Thiamine HCl 0.9% Sodium Chloride Injection USP Recalled by Fresenius Kabi...

The Issue: cGMP violations

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

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 25, 2024· Fresenius Kabi Compounding, LLC

Recalled Item: Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP Recalled...

The Issue: cGMP violations

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

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 25, 2024· Fresenius Kabi Compounding, LLC

Recalled Item: NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP Recalled by...

The Issue: cGMP violations

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

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 25, 2024· Fresenius Kabi Compounding, LLC

Recalled Item: NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP Recalled by...

The Issue: cGMP violations

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

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 25, 2024· Fresenius Kabi Compounding, LLC

Recalled Item: Phenylephrine HCl 0.9% Sodium Chloride Injection USP Recalled by Fresenius...

The Issue: cGMP violations

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

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 25, 2024· Fresenius Kabi Compounding, LLC

Recalled Item: EPINEPHrine 0.9% Sodium Chloride Injection USP Recalled by Fresenius Kabi...

The Issue: cGMP violations

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

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 25, 2024· Fresenius Kabi Compounding, LLC

Recalled Item: Oxytocin 0.9% Sodium Chloride Injection USP Recalled by Fresenius Kabi...

The Issue: cGMP violations

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

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 25, 2024· Fresenius Kabi Compounding, LLC

Recalled Item: Phenylephrine HCl 0.9% Sodium Chloride Injection USP Recalled by Fresenius...

The Issue: cGMP violations

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

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 25, 2024· Fresenius Kabi Compounding, LLC

Recalled Item: Phenylephrine HCl 0.9% Sodium Chloride Injection USP Recalled by Fresenius...

The Issue: CGMP violations

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

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 25, 2024· Fresenius Kabi Compounding, LLC

Recalled Item: Phenylephrine HCl 0.9% Sodium Chloride Injection USP Recalled by Fresenius...

The Issue: cGMP violations

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

Class II — Potential Health HazardOngoing
Refund
Medical DeviceSeptember 25, 2024· Cardinal Health 200, LLC

Recalled Item: Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack...

The Issue: Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin...

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 25, 2024· Biocare Medical, LLC

Recalled Item: intelliPATH Universal HRP Detection Kit Recalled by Biocare Medical, LLC Due...

The Issue: Kits containing the DAB chromogen buffer, intended for use in either manual...

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

Class II — Potential Health HazardOngoing