State

Pennsylvania product recalls

72,919 recalls have nationwide distribution and so reach Pennsylvania. 11,918 additional recalls listed Pennsylvania specifically in their distribution scope.

What the numbers show

Total: 11,918
Critical: 1,922
Severe: 2,866
Most recent: 2026-09-09

Of the 11,918 recalls naming Pennsylvania we have scored against our rubric, 1,922 (16%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,866 (24%) are Severe.

Which agencies issued them

These figures cover only the 11,918 recalls whose distribution notice names Pennsylvania specifically. The 72,919 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

2176–2200 of 84837

HighFDA (Devices)·Z-1960-2026·2026-05-06
Philips Ingenia Ambition S MRI Systems Recalled for Stiffness Value Errors
Philips is recalling certain Ingenia Ambition S MRI systems with MR Elastography software due to potential stiffness value errors that may occur when specific image reconstruction parameters are used in combination with Resoundant's algorithm.
Product
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1991-2026·2026-05-06
Depuy Synthes ATTUNE Revision Hinge Femoral Knee Component Recall
Depuy Synthes is recalling 3 units of the ATTUNE Revision Hinge Femoral (Right, Size 5, Cemented) knee implant due to external sterile packaging adhered to internal sterile packaging, potentially compromising product sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2000-2026·2026-05-06
i-STAT Blood Gas Analyzer Cartridges Recalled for Inaccurate Results
Abbott is recalling certain i-STAT EG6+, EG7+, and G3+ blood gas cartridges that may report falsely high CO2 and falsely low pH results due to a manufacturing issue, potentially leading to unnecessary or harmful clinical interventions.
Product
i-STAT EG6+ cartridge; List Number: 03P77-25;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2006-2026·2026-05-06
Leksell Vantage Arc System locking mechanism may not secure properly
Elekta, Inc. is recalling the Leksell Vantage Arc System because locking mechanisms may fail to properly secure to the Arc system, which could cause coordinate shifting during medical procedures.
Product
Brand Name: Leksell Vantage Arc System REF: 1053958
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-2040-2026·2026-05-06
Medline Medical Kits Recalled for Non-Sterile Alcohol Prep Pads
Medline Industries is recalling specific blood culture and blood draw kits containing Webcol Large Alcohol Prep Pads that were found to be non-sterile due to bacterial contamination discovered during a sterilization audit.
Product
Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medline Kit SKU DYNDH1520; 2. BLOOD DRAW KIT, Medline Kit SKU EBSI1317.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2005-2026·2026-05-06
epoc BGEM BUN Test Card for epoc Blood Analysis System
Siemens Healthcare Diagnostics is recalling epoc BGEM BUN Test Cards due to risk of inaccurate pH and carbon dioxide readings that could lead to inappropriate or missed treatment of acid-base disorders.
Product
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0684-2026·2026-05-06
My Mochi strawberry frozen dessert contains a foreign object
My Mochi Strawberry flavoured Non-Dairy Frozen Dessert is being recalled after a foreign object was found inside a retail container. 1,270 cases are affected.
Product
My Mochi Strawberry flavored Non-Dairy Frozen Dessert; 7.5 oz; 6 pieces per container. UPC# 0-70934-99645-8
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1987-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall
DePuy Synthes is recalling one lot of ATTUNE Revision Hinge Femoral components (left size 7, part number 150450107) due to external sterile packaging adhered to internal packaging, potentially compromising product sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1989-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral Component Recall
DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral RT Size 3 Cement components due to external sterile packaging that was adhered to internal sterile packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2041-2026·2026-05-06
Medline and Centurion Medical Convenience Kits Recalled for Non-Sterile Alcohol Prep Pads
Medline Industries is recalling specific lots of medical convenience kits containing non-sterile Webcol Large Alcohol Prep Pads due to discovery of Paenibacillus phoenicis contamination. Affected kits were distributed nationwide.
Product
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE KIT, Medline Kit SKU UROT1044; 2. IV START KIT WITH EXTENSION TUBING, Medline Kit SKU IV8770; 3. IV START KIT, Medline Kit SKU DYNDV2520; 4. ARTERIAL LINE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1999-2026·2026-05-06
Abbott i-STAT EG7+ Blood Gas Cartridges Reporting Inaccurate Results
Abbott Point Of Care is recalling approximately 7.6% of specific i-STAT EG7+ cartridge lots due to a manufacturing issue causing falsely high pCO2 and low pH readings. Inaccurate results could lead clinicians to make unnecessary or harmful medical interventions.
Product
i-STAT EG7+ cartridge; List Number: 03P76-25;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2001-2026·2026-05-06
Abbott i-STAT Blood Gas Cartridges Reporting Inaccurate pH and PCO2 Results
Abbott Point Of Care Inc. is recalling approximately 7.6% of i-STAT G3+, i-STAT EG6+, and i-STAT EG7+ blood gas cartridges due to a manufacturing issue causing falsely high PCO2 and low pH readings, which may lead to unnecessary or harmful clinical interventions.
Product
i-STAT G3+ cartridge; List Number: 03P78-26;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1965-2026·2026-05-06
Philips SmartPath to dStream MR Elastography System Reconstruction Error
Philips is recalling certain SmartPath to dStream 1.5T MR Elastography systems due to potential stiffness value errors when specific image reconstruction parameters are used, which may cause incorrect voxel size settings in the default MRE scan protocol.
Product
Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.
Category
Medical Device
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 (Devices)·Z-1985-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral Component Recall
DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral Left Size 4 Cement prosthetic components because external sterile packaging was found adhered to internal packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1955-2026·2026-05-06
Philips Evolution 3.0T MR Elastography upgrade stiffness calculation error
Philips Evolution upgrade 3.0T with MR Elastography systems may produce incorrect stiffness values when specific image reconstruction parameters are used, causing voxel size settings to display smaller than intended.
Product
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.
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-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-2002-2026·2026-05-06
Philips Bridge Prep Kit catheter may experience resistance during advancement
Merit Medical Systems is recalling the Philips Bridge Prep Kit (Lot K12-09098B) because the catheter may experience resistance when being advanced over the guidewire.
Product
Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
Category
Medical Device
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
ModerateFDA (Drugs)·D-0508-2026·2026-05-06
Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations
Wells Pharma is recalling fentanyl citrate injectable solution (50 mcg/5mL, NDC 73702-202-15) nationwide due to cGMP manufacturing deviations. The recall affects 50 syringes from Lot 020226202150202 with expiration date 05/05/2026.
Product
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.
Category
Drug
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-1993-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral implant sterility concern
DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral RT SZ 8 CEM implants due to external sterile packaging adhered to internal sterile packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.
Category
Medical Device
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-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