State

Pennsylvania product recalls

19,704 recalls have nationwide distribution and so reach Pennsylvania. 0 additional recalls listed Pennsylvania specifically in their distribution scope.

About recalls in Pennsylvania

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Pennsylvania consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

826–850 of 19704

ModerateFDA (Drugs)·D-0504-2026·2026-05-06
Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations
Wells Pharma of Houston is voluntarily recalling 2,940 IV bags of fentanyl citrate injectable solution due to cGMP (current good manufacturing practice) deviations. The product was distributed nationwide.
Product
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1983-2026·2026-05-06
BD GasPak EZ Campy Pouch System Recall for Below-Specification Gas Production
Becton Dickinson & Co. is recalling certain lots of BD GasPak EZ Campy Gas Generating Pouch Systems because gas generating sachets may produce carbon dioxide levels below specification, potentially affecting microbiologic laboratory testing.
Product
BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2004-2026·2026-05-06
Philips Bridge Prep Kit catheter may experience resistance during advancement
Merit Medical Systems, Inc. is recalling the Philips Bridge Prep Kit (Ref K12-09098C) because the catheter may experience resistance when being advanced over the guidewire during use.
Product
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1961-2026·2026-05-06
Philips Ingenia Ambition X MRI Systems Stiffness Value Error Recall
Philips Ingenia Ambition X MRI systems with MR Elastography may produce incorrect stiffness values due to image reconstruction parameter errors, affecting diagnostic accuracy.
Product
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0500-2026·2026-05-06
iVIZIA Dry Eye Lubricant Drops Recalled for Sterility Assurance
Thea Pharma, Inc. is recalling iVIZIA Dry Eye (Povidone 0.5%) lubricant eye drops nationwide due to the FDA's discovery of manufacturing process deviations that affect the product's sterility assurance.
Product
IVIZIA DRY EYE — IVIZIA DRY EYE (POVIDONE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0506-2026·2026-05-06
Fentanyl Citrate Injectable Solution Recall Due to cGMP Deviations
Wells Pharma of Houston is recalling fentanyl citrate injectable solution (1000 mcg/50 mL) due to current good manufacturing practice (cGMP) deviations. The recall affects 150 syringes distributed nationwide.
Product
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0502-2026·2026-05-06
Injectable Phenylephrine Hydrochloride Solution Recall Due to cGMP Deviations
Wells Pharma of Houston LLC is recalling Phenylephrine Hydrochloride Injectable Solution, 40 mg, 250 mL IV bags nationwide due to cGMP deviations. The recall affects 13,070 IV bags with multiple lot numbers and expiration dates through July 2026.
Product
Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1986-2026·2026-05-06
Depuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Compromise
Depuy Synthes is recalling ATTUNE Revision Hinge Femoral components because external sterile packaging was found adhered to internal sterile packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1962-2026·2026-05-06
Philips Ingenia Elition S MRI stiffness value error correction
Philips Ingenia Elition S MRI systems with MR Elastography may display incorrect voxel size settings in the default scan protocol when certain image reconstruction parameters are used, potentially leading to stiffness value errors.
Product
Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1953-2026·2026-05-06
Philips Achieva 3.0T MR Elastography system stiffness value error recall
Philips is recalling the Achieva 3.0T with MR Elastography system due to potential stiffness value errors in image reconstruction when specific parameters are used, which may cause incorrect voxel size display in the default scan protocol.
Product
Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1949-2026·2026-05-06
Genius Review Station Display Modified Outside Validated Configuration
Hologic is correcting Genius Review Station displays (model CMP-01669) that were modified by users outside the FDA-cleared configuration. The devices need restoration to validated settings per the manufacturer's Operator's Manual.
Product
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics S
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1966-2026·2026-05-06
Philips SmartPath dStream 3.0T MRI Scanner Software Parameter Error Recall
Philips is recalling one unit of the SmartPath to dStream 3.0T MRI scanner with MR Elastography due to potential stiffness value calculation errors when specific image reconstruction parameters are used.
Product
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1968-2026·2026-05-06
Philips SmartPath to Ingenia Elition X MR Elastography Stiffness Value Errors
Philips is recalling three models of SmartPath to Ingenia Elition X with MR Elastography devices due to potential stiffness value errors when specific image reconstruction parameters are combined with Resoundant's algorithm.
Product
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1945-2026·2026-05-06
Kiwi Omni Vacuum Delivery System devices recalled for traction force gauge breakage
Clinical Innovations is recalling the Kiwi Omni Vacuum Delivery System (Model VAC-6000MT) due to complaints of device breakage at the traction force gauge to handle joint. The recall affects 49,175 devices distributed nationwide and internationally.
Product
Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device desig
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2003-2026·2026-05-06
Philips Bridge Prep Kit catheter may experience resistance during advancement
Merit Medical Systems is recalling the Philips Bridge Prep Kit (REF K12-09098C) because the catheter may experience resistance when advanced over the guidewire, potentially affecting proper device function.
Product
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1967-2026·2026-05-06
Philips SmartPath to dStream MR Elastography Software Parameter Error
Philips is recalling specific units of SmartPath to dStream for XR and 3.0T with MR Elastography due to potential stiffness value errors when certain image reconstruction parameters are used with Resoundant's algorithm, which may cause voxel size settings in the default MRE scan protocol to display incorrectly.
Product
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1952-2026·2026-05-06
Philips Achieva 1.5T MRI System MRE Protocol Parameter Error Recall
Philips Achieva 1.5T MRI systems with MR Elastography may display incorrect stiffness values and voxel size settings when certain image reconstruction parameters are used together, potentially affecting diagnostic accuracy.
Product
Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0501-2026·2026-05-06
Similasan iVIZIA Sterile Lubricant Eye Drops Recall Due to Sterility Assurance
Thea Pharma, Inc. is recalling Similasan iVIZIA Sterile Lubricant Eye Drops due to the lack of assurance of sterility caused by manufacturing deviations found by the FDA.
Product
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1944-2026·2026-05-06
Vacuum Bag SU Large non-sterile specimen container recall
Milestone S.R.L. is recalling Vacuum Bag SU Large non-sterile specimen containers (Model 68409SS) due to the possibility of reagent leakage from the container. The recall affects approximately 61,600 units distributed worldwide.
Product
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1980-2026·2026-05-06
Dimension Creatinine Flex Reagent Cartridge Recalled for Imprecision Results
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridges due to potential imprecision in creatinine test results that could be erroneously increased or decreased.
Product
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0503-2026·2026-05-06
Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations
Wells Pharma is recalling fentanyl citrate injectable solution (1000 mcg/100 mL, 10 mcg per mL) distributed nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects 4,030 IV bags with various lot numbers and expiration dates between April and June 2026.
Product
fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1957-2026·2026-05-06
Philips Ingenia 1.5T CX MRI Machine MRE Stiffness Measurement Error
Philips is recalling the Ingenia 1.5T CX MRI machine with MR Elastography because certain image reconstruction parameters may cause stiffness value measurement errors in the default scan protocol.
Product
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0526-2026·2026-05-06
Alendronate Sodium Oral Solution Recalled for Out-of-Specification Assay Results
Hikma Pharmaceuticals USA Inc. is recalling Alendronate Sodium Oral Solution 70 mg/75 mL due to out-of-specification assay results found in a limited number of bottles. The affected lot (AC2040A) was distributed nationwide.
Product
ALENDRONATE SODIUM — ALENDRONATE SODIUM (ALENDRONATE SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0505-2026·2026-05-06
Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations
Wells Pharma of Houston LLC has recalled fentanyl citrate injectable solution (1250 mcg/25mL) distributed nationwide due to cGMP deviations. The recall involves 50 syringes from Lot 011226204250063, expiring 05/14/2026.
Product
fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0494-2026·2026-05-06
Levocarnitine Injection USP Missing Label Recall
American Regent, Inc. is recalling Levocarnitine Injection USP (1 g/5 mL) due to missing labeling on certain lots. The affected product was distributed nationwide.
Product
LEVOCARNITINE — LEVOCARNITINE (LEVOCARNITINE)
Category
Drug
Distribution
Distributed nationwide