Product Recalls in Pennsylvania

Product recalls affecting Pennsylvania — including food, drugs, consumer products, medical devices, and vehicles distributed to Pennsylvania. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,885 recalls have been distributed to Pennsylvania in the last 12 months.

55,602 total recalls
2,885 in last 12 months

Showing 52615280 of 29,947 recalls

Medical DeviceNovember 27, 2023· Ortho-Clinical Diagnostics, Inc.

Recalled Item: VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack Recalled...

The Issue: Affected lots may experience increased calibration failures or an increase...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 27, 2023· Mirion Technologies (Capintec), Inc.

Recalled Item: Captus 4000e Thyroid Uptake Systems- Intended to be used by Recalled by...

The Issue: Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 27, 2023· Philips Respironics, Inc.

Recalled Item: Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B...

The Issue: The following was missing from the Contraindications Statement: The AVAPS-AE...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 23, 2023· ACTIM OY

Recalled Item: Actim PROM dipstik Recalled by ACTIM OY Due to Interference testing has...

The Issue: Interference testing has shown that the presence of personal lubricants in...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 23, 2023· FUJIFILM Healthcare Americas Corporation

Recalled Item: The device is a mobile x-ray system designed to work Recalled by FUJIFILM...

The Issue: When the key switch is turned on, the exposure conditions are set to the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 21, 2023· Beckman Coulter, Inc.

Recalled Item: Access Ultrasensitive Insulin only used on the DxI 9000 Access Recalled by...

The Issue: There is an issue with the Access Ultrasensitive Insulin assay protocol file...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 21, 2023· Beckman Coulter, Inc.

Recalled Item: DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior...

The Issue: There are potential performance issues found in the DxI 9000 Access...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 20, 2023· Randox Laboratories Ltd.

Recalled Item: Calibration Serum Level 3 CAL2351 Recalled by Randox Laboratories Ltd. Due...

The Issue: CK Total in Calibration Serum Level 3, CAL2351, is running with a positive...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 20, 2023· Randox Laboratories Ltd.

Recalled Item: Calibration Serum Level 3 - IVD For use as a Recalled by Randox Laboratories...

The Issue: Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 20, 2023· Keystone Industries

Recalled Item: KeySplint Hard Clear - Indicated for the fabrication of orthodontic Recalled...

The Issue: Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 20, 2023· ResMed Ltd.

Recalled Item: AirFit N10 Nasal Masks and User Guide Recalled by ResMed Ltd. Due to Masks...

The Issue: Masks non-invasive interface for channeling airflow to patients have magnets...

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

Class I — Serious Health HazardOngoing
Medical DeviceNovember 20, 2023· ResMed Ltd.

Recalled Item: AirFit F20 Full Face Mask and User Guide Recalled by ResMed Ltd. Due to...

The Issue: Masks non-invasive interface for channeling airflow to patients have magnets...

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

Class I — Serious Health HazardOngoing
Medical DeviceNovember 20, 2023· LEICA BIOSYSTEMS NUSSLOCH GMBH

Recalled Item: Leica HistoCore PEGASUS (PROCESSOR Recalled by LEICA BIOSYSTEMS NUSSLOCH...

The Issue: There is an issue regarding poorly processed and/or damaged biopsy tissue...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 20, 2023· Olympus Corporation of the Americas

Recalled Item: OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model:...

The Issue: Instructions for Use-User Deviations related to the reprocessing of the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 20, 2023· ROi CPS LLC

Recalled Item: Regard Dressing change kit Recalled by ROi CPS LLC Due to ROi CPS...

The Issue: ROi CPS manufactured and distributed medical convenience kits with an...

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

Class I — Serious Health HazardOngoing
Medical DeviceNovember 20, 2023· Olympus Corporation of the Americas

Recalled Item: OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model:...

The Issue: Instructions for Use-User Deviations related to the reprocessing of the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 20, 2023· Medtronic Inc.

Recalled Item: Protege GPS Self-Expanding Peripheral Stent System Recalled by Medtronic...

The Issue: Seal defects could compromise the ability of the product packaging to...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 20, 2023· ResMed Ltd.

Recalled Item: AirTouch F20 Full Face Mask and User Guide Recalled by ResMed Ltd. Due to...

The Issue: Masks non-invasive interface for channeling airflow to patients have magnets...

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

Class I — Serious Health HazardOngoing
Medical DeviceNovember 20, 2023· ResMed Ltd.

Recalled Item: AirFit N20 Nasal Mask and User Guide Recalled by ResMed Ltd. Due to Masks...

The Issue: Masks non-invasive interface for channeling airflow to patients have magnets...

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

Class I — Serious Health HazardOngoing
Medical DeviceNovember 20, 2023· ResMed Ltd.

Recalled Item: AirFit F30i Full Face Mask and User Guide Recalled by ResMed Ltd. Due to...

The Issue: Masks non-invasive interface for channeling airflow to patients have magnets...

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

Class I — Serious Health HazardOngoing