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. 2,562 recalls have been distributed to Maine in the last 12 months.

48,770 total recalls
2,562 in last 12 months

Showing 28012820 of 27,655 recalls

Medical DeviceOctober 3, 2024· DeRoyal Industries Inc

Recalled Item: DeRoyal C-SECTION TRACEPACK Recalled by DeRoyal Industries Inc Due to...

The Issue: DeRoyal is recalling certain lots of surgical procedure pack products that...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 1, 2024· Advanced Medical Solutions Ltd.

Recalled Item: MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE Recalled by Advanced...

The Issue: Due to defects on primary packaging pouch that compromise the device's...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 1, 2024· Advanced Medical Solutions Ltd.

Recalled Item: Hollister CalciCare Calcium Alginate Dressing calcium alginate dressings...

The Issue: Due to defects on primary packaging pouch that compromise the device's...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 1, 2024· Advanced Medical Solutions Ltd.

Recalled Item: McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for...

The Issue: Due to defects on primary packaging pouch that compromise the device's...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 1, 2024· Abbott Medical

Recalled Item: Merlin@home Transmitter The Merlin@home" (M@h) transmitter is intended...

The Issue: Due to heart transmitter not being able to upgrade to the current software...

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

Class III — Low RiskOngoing
Medical DeviceOctober 1, 2024· Abbott Medical

Recalled Item: Merlin@home with the MerlinOnDemand capability Transmitter Merlin@home with...

The Issue: Due to heart transmitter not being able to upgrade to the current software...

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

Class III — Low RiskOngoing
Medical DeviceSeptember 30, 2024· Bard Peripheral Vascular Inc

Recalled Item: Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT...

The Issue: Disposable biopsy instruments were potentially manufactured missing the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 30, 2024· Siemens Healthcare Diagnostics, Inc.

Recalled Item: IMMULITE 2000 PSA assay Recalled by Siemens Healthcare Diagnostics, Inc. Due...

The Issue: The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 27, 2024· Westmed, Inc.

Recalled Item: 1) Flex Extenders Recalled by Westmed, Inc. Due to Due to connector within...

The Issue: Due to connector within the circuit flex extender not meeting specifications...

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: 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
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
Medical DeviceSeptember 24, 2024· Siemens Healthcare Diagnostics Inc

Recalled Item: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System Recalled...

The Issue: Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium...

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

Class II — Potential Health HazardOngoing