State

Pennsylvania product recalls

73,100 recalls have nationwide distribution and so reach Pennsylvania. 11,926 additional recalls listed Pennsylvania specifically in their distribution scope.

What the numbers show

Total: 11,926
Critical: 1,922
Severe: 2,869
Most recent: 2026-09-25

Of the 11,926 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 2,869 (24%) are Severe.

Which agencies issued them

These figures cover only the 11,926 recalls whose distribution notice names Pennsylvania specifically. The 73,100 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

9126–9150 of 85026

HighFDA (Drugs)·D-0158-2025·2025-01-01
Duloxetine Delayed-Release Capsules Recalled Nationwide for Excess N-Nitroso Impurity
Amerisource Health Services LLC is recalling Duloxetine Delayed-Release Capsules due to N-nitroso-duloxetine impurity above recommended limits. The affected product was distributed nationwide in 1,815 bottles with two specific lot numbers and expiration dates.
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0725-2025·2025-01-01
Surgical Patties and Strips with Endotoxin Contamination in Medline Convenience Kits
Medline Industries is recalling surgical patties and strips in specific lots of KIT,SPINE LH Convenience Kits due to higher-than-expected endotoxin levels in raw materials. The contamination may result in out-of-specification endotoxin in finished sterile products.
Product
KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0732-2025·2025-01-01
Abbott Vascular Inflation Device May Leak During Cardiovascular Procedures
Abbott Vascular is recalling the 20/30 Priority Pack Accessory Kit w/Copilot inflation device used in cardiovascular procedures because it may leak at connection points, potentially causing air embolism.
Product
20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-0730-2025·2025-01-01
Abbott 20/30 Indeflator devices recalled for potential leak risk
Abbott Vascular is recalling 20/30 Indeflator devices used in cardiovascular procedures due to potential leaks that could cause air embolism.
Product
20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-0722-2025·2025-01-01
Surgical Patties and Strips Recalled for Elevated Endotoxin Levels in Kits
Medline Industries is recalling SEPTOPLASTY PACK convenience kits nationwide due to higher-than-expected endotoxin levels in surgical patties and strips. The contamination may pose infection risks during surgical procedures.
Product
SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0728-2025·2025-01-01
O&M Halyard Procedure Masks Recalled for Unmet Bioburden Testing Requirements
O&M HALYARD is recalling O&M Halyard Procedure Masks (Product Code 47117) nationwide because they do not meet bioburden testing requirements printed on the packaging.
Product
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0161-2025·2025-01-01
Duloxetine 30mg Capsules Recalled Due to Nitrosamine Impurity
Breckenridge Pharmaceutical is recalling 163,883 bottles of Duloxetine 30mg capsules nationwide due to N-nitroso-duloxetine impurity above FDA-recommended limits.
Product
DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0755-2025·2025-01-01
Medline Surgical Scissors Recalled for Sterility Seal Defect
Medline O.R. scissors may have weak seals that compromise sterility, increasing risk of contamination and infection. Approximately 21,440 units from lot 2023052490 have been recalled nationwide.
Product
O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0156-2025·2025-01-01
Duloxetine Delayed-Release Capsules Recalled Due to N-nitroso Impurity Contamination
Amerisource Health Services is recalling certain lots of Duloxetine Delayed-Release Capsules due to N-nitroso impurity levels exceeding recommended limits. Consumers with the medication should contact their healthcare provider.
Product
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0752-2025·2025-01-01
FDA Recalls Medical Spine Component Due to Manufacturing Defects
SEASPINE Orthopedics is recalling 191 Daytona Small Stature Ti Locking Caps due to manufacturing defects that prevent proper component mating.
Product
Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 Software Version: N/A Product Description: Locking Cap Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0740-2025·2025-01-01
Siemens Blood Analysis Device Recalled Over Patient Name Mix-up Software Defect
Siemens is recalling the epoc NXS blood analysis system due to a software flaw that can assign incorrect patient names to test results, risking misdiagnosis or mistreatment if the operator doesn't verify the patient name.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0735-2025·2025-01-01
Blood analyzer system recalled for patient name assignment software error
Siemens recalled its epoc NXS Host blood analyzer due to a software malfunction that can assign incorrect patient names to test results, potentially leading to misdiagnosis or mistreatment.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0726-2025·2025-01-01
Surgical procedure kits recalled for elevated endotoxin levels
Medline surgical kits containing sterile surgical patties and strips have been recalled due to higher-than-expected endotoxin levels in raw materials. The affected supplies may pose a risk during sterile surgical procedures.
Product
Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N; 2) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119U; 3) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119V; 4) CRANIOTOMY CDS, SKU CDS981753K; 5) LAMINECTOMY CDS-LF, SKU CDS981923X; 6)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0724-2025·2025-01-01
Medline Surgical Patties and Strips Recalled for Out-of-Spec Endotoxin Contamination
Medline is recalling surgical patties and strips in custom surgical kits due to higher-than-expected endotoxin levels in raw materials. These may result in out-of-specification endotoxin levels in finished sterile products.
Product
Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; 2) NEURO KIT, SKU CDS981327Q; 3) NEURO POSTERIOR SPINE PACK-LF, SKU DYNJ0311501I; 4) ACOUSTIC NEUROMA PACK-LF, SKU DYNJ37741D; 5) SCRIPPS SW NEURO PACK-LF, SKU D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0746-2025·2025-01-01
BD FACSLyric Flow Cytometer Power Supply May Fail During Use
BD FACSLyric flow cytometers are recalled for power supply failures that may prevent the device from powering on, risking specimen loss and potential respiratory effects from fume inhalation.
Product
Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cy
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0723-2025·2025-01-01
Medline surgical patties and strips recalled for endotoxin contamination
Medline surgical patties and strips used in certain procedure convenience kits were found to contain higher-than-expected endotoxin levels that may exceed safety specifications. The affected kits were distributed nationwide and in Canada.
Product
Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU DYNJ21927Q; 3) MVFF/FIBU #54-RF, SKU DYNJ21927S; 3) NEURO PEDIATRIC, SKU DYNJ61607A; 4) CRANIOTOMY PACK, SKU DYNJ66419C; 5) LYMPHATIC BYPASS PACK, SKU DYNJ69907;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0164-2025·2025-01-01
Diagnostic drug kit recalled due to sterility concerns and vial integrity issues
Curium US is recalling Technetium TC 99m Sestamibi diagnostic kits (Lot 092-24006) due to improper vial crimps that could compromise sterility assurance. The recall affects approximately 5,160 vials distributed nationwide.
Product
TECHNETIUM TC 99M SESTAMIBI — TECHNETIUM TC 99M SESTAMIBI (TECHNETIUM TC 99M SESTAMIBI)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0165-2025·2025-01-01
Duloxetine delayed-release capsules recalled due to manufacturing impurity
Duloxetine delayed-release 60mg capsules are being recalled nationwide due to N-nitroso-duloxetine impurity above recommended interim limits. Two lot numbers are affected: J0786744-061724 (blister cards) and B3002625-060524 (bottles).
Product
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0748-2025·2025-01-01
BD FACSLyric Flow Cytometer Power Supply Module Failure Risk
BD is recalling power supply modules on FACSLyric flow cytometers that may fail to power on or stay on. Failure could cause lab staff to inhale fumes and patients to need repeat blood draws.
Product
FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath ta
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0741-2025·2025-01-01
Siemens epoc blood analyzer software assigns incorrect patient names
Siemens epoc NXS blood analysis system has a software defect that can incorrectly assign patient names to blood test results, potentially causing misdiagnosis or mistreatment.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0759-2025·2025-01-01
Medline ST IUD Removal Hook Recalled Due to Weak Seals and Sterility Risk
Medline Industries is recalling 21,440 units of the ST IUD Removal Hook due to weak seals that may compromise sterility. The defect is undetectable to users and could increase infection risk.
Product
ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0762-2025·2025-01-01
MISHA Knee System Implants recalled due to fracture risk
Moximed is recalling 115 MISHA Knee System Implants in multiple US states due to a supplier component defect that may cause the implant to fracture, potentially leading to pain, swelling, and stiffness.
Product
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0721-2025·2025-01-01
Medline Surgical Patties and Strips Recalled for Endotoxin Contamination
Medline recalls surgical patties and strips from specific kit lots due to higher-than-expected endotoxin levels. The 318 kits were distributed in the United States and Canada.
Product
Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0753-2025·2025-01-01
Merlin PCS 3650 Pacemaker Programmer Software Anomaly May Cause Loss of Pacing
A software anomaly in Abbott's Merlin PCS 3650 programmer may prevent proper finalization of leadless pacemakers, causing loss of pacing function. The issue occurs when specific actions combine with brief telemetry loss.
Product
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0720-2025·2025-01-01
Medline surgical procedure kits recalled due to endotoxin contamination
Medline brand surgical procedure convenience kits in specific lots contain higher-than-expected endotoxin levels in surgical patties and strips. The contamination was found in raw materials used to produce sterile components.
Product
Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU DYNJ33520A; 4) SINUS PACK, SKU DYNJ44845G; 5) SINUS PACK, SKU DYNJ48330B; 6) ENT PACK, SKU DYNJ50572; 7) ENT PACK, SKU DYNJ53573A; 8
Category
Medical Device
Distribution
Distributed nationwide