Product Recalls in Delaware

Product recalls affecting Delaware — including food, drugs, consumer products, medical devices, and vehicles distributed to Delaware. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,695 recalls have been distributed to Delaware in the last 12 months.

48,330 total recalls
2,695 in last 12 months

Showing 12411260 of 48,330 recalls

DrugSeptember 17, 2025· Glenmark Pharmaceuticals Inc., USA

Recalled Item: Azelaic Acid Gel Recalled by Glenmark Pharmaceuticals Inc., USA Due to CGMP...

The Issue: CGMP Deviations: Market complaints received for gritty texture (grainy)

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

Class II — Potential Health HazardOngoing
Refund
Medical DeviceSeptember 17, 2025· Enterix, Inc.

Recalled Item: InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure Recalled...

The Issue: InSure ONE failed sensitivity testing when used with Test Card Lot T241102,...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 17, 2025· ELEKTA SOLUTIONS AB

Recalled Item: MOSAIQ Oncology Information System Software Builds 3.1.3 Recalled by ELEKTA...

The Issue: When appending a care plan that contains one or more wave medication orders,...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 17, 2025· Beckman Coulter Inc.

Recalled Item: SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent Recalled by Beckman...

The Issue: Beckman Coulter has identified that there is an increased probability...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 17, 2025· Baxter Healthcare Corporation

Recalled Item: Oral Probe (Product code 02893-000) Recalled by Baxter Healthcare...

The Issue: Affected oral/axillary probes were inadvertently programmed with the rectal...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 17, 2025· CPM Medical Consultants, LLC.

Recalled Item: Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400...

The Issue: Instructions for use for a foot plating system is being updated to remove...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 17, 2025· Percussionaire Corporation

Recalled Item: Phasitron 5 Recalled by Percussionaire Corporation Due to IFU update;...

The Issue: IFU update; in-line valve, with pressure relief seal may leak when used with...

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

Class I — Serious Health HazardOngoing
DrugSeptember 16, 2025· IntegraDose Compounding Services LLC

Recalled Item: Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use...

The Issue: Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.

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

Class I — Serious Health HazardOngoing
Refund
DrugSeptember 16, 2025· ACCORD HEALTHCARE, INC.

Recalled Item: Levothyroxine Sodium Tablets Recalled by ACCORD HEALTHCARE, INC. Due to...

The Issue: Subpotent: During long term stability testing of Levothyroxine Sodium...

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

Class II — Potential Health HazardOngoing
Refund
Medical DeviceSeptember 16, 2025· Medtronic Sofamor Danek USA Inc

Recalled Item: Catalyft PL & PL40 Expandable Interbody System labeled as follows Recalled...

The Issue: Expandable interbody system cage may loose height or collapse (loss of...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 16, 2025· Surgical Theater Inc

Recalled Item: SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR...

The Issue: A software anomaly, under specific conditions when large rotational...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 16, 2025· Spacelabs Healthcare, Ltd.

Recalled Item: Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number:...

The Issue: Due to two distinct issues: 1. During patient admission, patient demographic...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 16, 2025· Surgical Theater Inc

Recalled Item: Surgical Planner Recalled by Surgical Theater Inc Due to A software anomaly,...

The Issue: A software anomaly, under specific conditions when large rotational...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 16, 2025· Surgical Theater Inc

Recalled Item: SuRgical Planner (SRP) Recalled by Surgical Theater Inc Due to A software...

The Issue: A software anomaly, under specific conditions when large rotational...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 16, 2025· Surgical Theater Inc

Recalled Item: Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP)...

The Issue: A software anomaly, under specific conditions when large rotational...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 16, 2025· Surgical Theater Inc

Recalled Item: SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR...

The Issue: A software anomaly, under specific conditions when large rotational...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 16, 2025· Surgical Theater Inc

Recalled Item: Surgical Navigation Advanced Platform (SNAP) Recalled by Surgical Theater...

The Issue: A software anomaly, under specific conditions when large rotational...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 16, 2025· Surgical Theater Inc

Recalled Item: Surgical Navigation Advanced Platform Patient Engagement (PE SNAP) Recalled...

The Issue: A software anomaly, under specific conditions when large rotational...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 16, 2025· Abiomed, Inc.

Recalled Item: Automated Impella Controller (AIC) labeled as the following with...

The Issue: Potential for Automated Impella Controller (AIC) purge pressure issues due...

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

Class I — Serious Health HazardOngoing
DrugSeptember 15, 2025· Graviti Pharmaceuticals Private Limited

Recalled Item: Bupropion Hydrochloride Extended-Release Tablets USP (XL) Recalled by...

The Issue: Failed Tablet/Capsule Specifications

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

Class II — Potential Health HazardOngoing
Refund