Product Recalls in Indiana

Product recalls affecting Indiana — including food, drugs, consumer products, medical devices, and vehicles distributed to Indiana. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,729 recalls have been distributed to Indiana in the last 12 months.

53,528 total recalls
2,729 in last 12 months

Showing 76617680 of 29,228 recalls

Medical DeviceSeptember 8, 2022· Abbott Vascular

Recalled Item: Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR Recalled by...

The Issue: An increase in clip locking malfunctions, Establish Final Arm Angle and Clip...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 8, 2022· Abbott Vascular

Recalled Item: Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR Recalled by...

The Issue: An increase in clip locking malfunctions, Establish Final Arm Angle and Clip...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 8, 2022· Abbott Vascular

Recalled Item: Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT Recalled by...

The Issue: An increase in clip locking malfunctions, Establish Final Arm Angle and Clip...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 7, 2022· Johnson & Johnson Surgical Vision, Inc.

Recalled Item: THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter Recalled by...

The Issue: Manufacturing error resulted in potential contamination of Bi-Directional...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 7, 2022· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: CENTURION SnagFree Chest Tube insertion Tray Recalled by MEDLINE INDUSTRIES,...

The Issue: One lot of chest tube insertion trays, containing a silk suture component...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 7, 2022· BALT USA, LLC

Recalled Item: Optima Coil System Model Number OPTI0208CSS10 Recalled by BALT USA, LLC Due...

The Issue: Product pouch label does not match up with carton label

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 6, 2022· Philips Respironics, Inc.

Recalled Item: Wisp and Wisp Youth Nasal Mask Recalled by Philips Respironics, Inc. Due to...

The Issue: No contraindication/warning regarding magnetic components in CPAP masks for...

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 6, 2022· Philips Respironics, Inc.

Recalled Item: DreamWisp Nasal Mask with Over the Nose Cushion Recalled by Philips...

The Issue: No contraindication/warning regarding magnetic components in CPAP masks for...

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 6, 2022· Philips Respironics, Inc.

Recalled Item: Philips Respironics Amara View Minimal Contact Full-Face Mask Recalled by...

The Issue: No contraindication/warning regarding magnetic components in CPAP masks for...

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 6, 2022· Philips North America Llc

Recalled Item: MR Patient Care Portal 5000 (Desktop Unit) Recalled by Philips North America...

The Issue: Device may intermittently fail to produce audio. Turning the unit off and on...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 6, 2022· Philips Respironics, Inc.

Recalled Item: Therapy Mask 3100 NC/SP Recalled by Philips Respironics, Inc. Due to No...

The Issue: No contraindication/warning regarding magnetic components in CPAP masks for...

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 6, 2022· Philips Respironics, Inc.

Recalled Item: Philips Respironics DreamWear Full Face Mask Recalled by Philips...

The Issue: No contraindication/warning regarding magnetic components in CPAP masks for...

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 2, 2022· LUMINOSTICS, INC dba CLIP HEALTH

Recalled Item: Clip COVID Rapid Antigen Test Kit (25-pack) Recalled by LUMINOSTICS, INC dba...

The Issue: COVID test kit shelf life was periodically extended, as real-time stability...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 2, 2022· Baxter Healthcare Corporation

Recalled Item: Starling Monitor Recalled by Baxter Healthcare Corporation Due to Labeling...

The Issue: Labeling has incorrect or incomplete Unique Device Identification (UDI)...

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

Class III — Low RiskOngoing
Medical DeviceSeptember 1, 2022· OMM Imports, Inc. dba Zero Gravity

Recalled Item: Recreo Hair Growth Laser Comb Recalled by OMM Imports, Inc. dba Zero Gravity...

The Issue: The firm distributed the laser products without affixing the warning,...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 1, 2022· Texas Medical Technology Inc.

Recalled Item: Disposable Surgical Level 3 Gown Recalled by Texas Medical Technology Inc....

The Issue: Surgical gowns recalled due to gown fabric failing to pass the hydrostatic...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 1, 2022· Johnson & Johnson Surgical Vision, Inc.

Recalled Item: Veritas Advanced Infusion Packs. Used in ophthalmic procedures. Recalled by...

The Issue: As a result of returned product complaints for Veritas Phaco packs related...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2022· Micro-X Ltd.

Recalled Item: MICRO-X ROVER MOBILE X-RAY SYSTEM Recalled by Micro-X Ltd. Due to Software...

The Issue: Software calibration error with product equip with a Dose Area Product (DAP)...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 30, 2022· PHONESOAP

Recalled Item: The product is a handheld ultraviolet-C germicidal wand and contains...

The Issue: Excessive ultraviolet-C radiation

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 30, 2022· SIEMENS HEALTHCARE DIAGNOSTICS INC

Recalled Item: N Antiserum to Human IgG Recalled by SIEMENS HEALTHCARE DIAGNOSTICS INC Due...

The Issue: N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect...

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

Class II — Potential Health HazardOngoing