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. 2,768 recalls have been distributed to Indiana in the last 12 months.

53,528 total recalls
2,768 in last 12 months

Showing 23412360 of 29,228 recalls

Medical DeviceJanuary 8, 2025· CareFusion 303, Inc.

Recalled Item: (1) Pyxis MedStation ES Recalled by CareFusion 303, Inc. Due to Software...

The Issue: Software issues could potentially result in: 1) delays in accessing...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 8, 2025· Ithera Medical Gmbh

Recalled Item: The MSOT Acuity Echo is a Class 4 medical laser Recalled by Ithera Medical...

The Issue: The MSOT Acuity Echo does not include an adequate instruction for safe...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 8, 2025· CareFusion 303, Inc.

Recalled Item: (1) BD Pyxis MedStation ES Recalled by CareFusion 303, Inc. Due to Labeling...

The Issue: Labeling is insufficient regarding delays in access to medication. The firm...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 8, 2025· Hologic, Inc.

Recalled Item: The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a Recalled by...

The Issue: Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850)...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 6, 2025· Sysmex America, Inc.

Recalled Item: Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6....

The Issue: Sysmex was made aware of a report of false results due to carry-over caused...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 6, 2025· Zimmer, Inc.

Recalled Item: NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E...

The Issue: It was identified internally that two commingle events occurred where the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 6, 2025· Zimmer, Inc.

Recalled Item: NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C...

The Issue: It was identified internally that two commingle events occurred where the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 3, 2025· XTANT Medical Holdings, Inc

Recalled Item: Irix-A Integrated Lumbar Fusion System Recalled by XTANT Medical Holdings,...

The Issue: Certain implants in the Irix-A Lumbar Fusion System were distributed while...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 3, 2025· LivaNova USA, Inc.

Recalled Item: Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva" Recalled by...

The Issue: Their is a potential that implanted pulse generators may stop delivering...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 3, 2025· LivaNova USA, Inc.

Recalled Item: Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO" Recalled by...

The Issue: Their is a potential that implanted pulse generators may stop delivering...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 2, 2025· Scientia Vascular, Inc.

Recalled Item: Socrates 38 Aspiration Catheter 127 cm length The Recalled by Scientia...

The Issue: Due to manufacturing non-conformance that resulted in channels in the seal...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 2, 2025· US Endodontics, LLC

Recalled Item: Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK...

The Issue: Due to devices being irradiated above the established specification which my...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 2, 2025· Beckman Coulter Inc.

Recalled Item: Access PCT Reagent Pack Recalled by Beckman Coulter Inc. Due to Identified...

The Issue: Identified reagent lots are experiencing a high rate of calibration failures...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 2, 2025· Belmont Instrument LLC

Recalled Item: Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Recalled...

The Issue: Disposable set may leak during priming from a female quick connector due to...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 31, 2024· Exactech, Inc.

Recalled Item: AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL Recalled...

The Issue: Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 31, 2024· Exactech, Inc.

Recalled Item: Novation XLE Item Number / Product Description: 140-22-70 NV EHXL Recalled...

The Issue: Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 31, 2024· Exactech, Inc.

Recalled Item: Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL Recalled by...

The Issue: Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 31, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY Recalled by MEDLINE...

The Issue: The catheter subassembly in the Integrated Arterial Catheter was...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 31, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT Recalled...

The Issue: The catheter subassembly in the Integrated Arterial Catheter was...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 28, 2024· Neilmed Pharmaceuticals Inc

Recalled Item: NeiMed NasoGel for DRY NOSES UDI-DI/code: 00705928045309 SKU...

The Issue: Due to nasal spray stability failure for bioburden.

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

Class II — Potential Health HazardOngoing