State

Pennsylvania product recalls

73,092 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 73,092 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

7926–7950 of 85018

HighFDA (Devices)·Z-1446-2025·2025-04-02
Medline Delivery and Labor Kits Recalled for Defective Plastic Syringes
Medline is recalling 1,958 delivery and labor procedure kits containing plastic syringes with leaks, breakage, and quality defects that may pose a risk to patient health.
Product
Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack Number DYNJ0968863M; 3) L & D PACK-LF, Pack Number DYNJ0373290N; 4) L&D PACK, Pack Number DYNJ51998A; 5) LABOR & DELIVERY PACK-LF, Pack Number DYNJ0348455P; 6) LAB
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1416-2025·2025-04-02
Baxter TruSystem 7500 Hybrid medical device software defect in emergency mode
Baxter is recalling 2 units of TruSystem 7500 Hybrid (MC) due to a software issue that disables the upper back section adjustment when emergency mode is activated.
Product
Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1465-2025·2025-04-02
Medline procedure kits with defective plastic syringes recalled due to leak and breakage risk
Medline procedure kits containing plastic syringes are being recalled due to leaks, breakage, and quality issues that may compromise sterile medical procedures. Approximately 14,589 units were distributed nationwide in the US and Canada.
Product
Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number DYNJ64332; 3) ARTHRO PACK-LF, Pack Number DYNJ38748F; 4) ARTHRO PACK-LF, Pack Number DYNJ38748F; 5) ARTHROGRAM PACK, Pack Number DYNJ65817; 6) ARTHROGRAM TR
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1439-2025·2025-04-02
Medline Procedure Kits With Defective Plastic Syringes Recalled
Medline is recalling surgical procedure kits with plastic syringes affected by a March 2024 FDA Safety Alert due to leaks, breakage, and quality issues that may pose risks to patients.
Product
Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNEE, Pack Number DYNJ56717A; 3) CVL INSERTION PACK, Pack Number CVI5065; 4) KT DR VELASCO FISTULA PACK, Pack Number DYNJ46648D; 5) PICC ABSCESS PACK-LF, Pac
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1440-2025·2025-04-02
Medline Procedure Kits Recalled for Defective Syringes Posing Patient Risk
Medline is recalling 808 medical procedure kits containing plastic syringes with quality defects that may leak or break during use. Affected customers should stop using these kits and contact Medline for replacement instructions.
Product
Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P PACK, Pack Number DYNJ44115A; 3) LARGE BIOPSY PACK NTX, Pack Number DYNJ68393A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1428-2025·2025-04-02
Medline Namic Convenience Kits Pressure Monitoring Lines Recalled for Manufacturing Defect
Medline is recalling 4400 Namic convenience kits with Pressure Monitoring Lines because the female luer fittings were manufactured with excess material near the fluid pathway.
Product
namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1438-2025·2025-04-02
Medline Surgical Procedure Kits Recalled for Defective Plastic Syringes
Medline Industries recalls 3,860 surgical procedure kits with defective plastic syringes that may leak or break during use. The affected kits are distributed in the US and Canada.
Product
Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J; 3) CABG, Pack Number DYNJ906462B; 4) CABG ACCESSORY PACK-LF, Pack Number DYNJ0261346U; 5) CARDIAC CATH PACEMAKER-LF, Pack Number DYNJ42997C;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1447-2025·2025-04-02
Medline procedure kits recalled for syringe quality defects
Medline Industries is recalling 1,711 procedure kits containing plastic syringes affected by manufacturing defects. The syringes may leak or break, posing a risk to patient safety during medical procedures.
Product
Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D; 2) CSMC/GYN LAPAROSCOPIC PACK-LF, Pack Number DYNJ0665103I; 3) DAVINCI PACK-RFD, Pack Number DYNJ47762O; 4) DAVINCI ROBOT PACK SLRMC, Pack Number DYNJ81236; 5) GENERAL ROBOTICS PACK, Pack
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1429-2025·2025-04-02
Medline Arterial Pressure Monitoring Line Kits Recalled for Manufacturing Defect
Medline is recalling certain arterial pressure monitoring line kits due to excess material on female luer fittings. The affected kits were distributed worldwide, including the United States.
Product
namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1466-2025·2025-04-02
Checkpoint Guardian Intraoperative Lead adhesive defect electrical leakage risk
The adhesive on Checkpoint Guardian Intraoperative Leads may not fully cover metallic wire components, leading to potential electrical current leakage. This could result in inconsistent muscle responses and affect surgical effectiveness.
Product
Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small Model/Catalog Number: REF# 9524 (Small) Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1460-2025·2025-04-02
Medline ReNewal Electrophysiology Catheters Recalled for Elevated Bacterial Endotoxin Levels
Medline is recalling ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters used in cardiac procedures because the devices may contain higher than expected levels of bacterial endotoxin.
Product
Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1427-2025·2025-04-02
CardioMEMS Heart Failure Monitoring System Recalled for Data Migration Issues
St. Jude Medical is recalling the CardioMEMS Heart Failure System due to data migration issues resulting in duplicated or missing patient information.
Product
CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 The CardioMEMS" HF System provides pulmonary art
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0297-2025·2025-04-02
Compounded Fentanyl-Ropivacaine Epidural Injection Recalled Due to Sterility Assurance Concerns
QuVa Pharma is recalling 1,765 cassettes of compounded epidural injection due to lack of sterility assurance. The affected lots were distributed nationwide to institutional and office locations.
Product
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Su
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0298-2025·2025-04-02
Babyganics Mineral Sunscreen Recalled for Failed Stability Specifications
Babyganics Sheer Blend SPF 50 Mineral Sunscreen is being recalled nationwide because ingredients separated during stability testing, prompting an FDA Class II recall.
Product
babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1464-2025·2025-04-02
Medline Procedure Kits Recalled for Syringe Quality Defects
Medline procedure kits with defective plastic syringes have been recalled due to leaks, breakage, and quality issues that may pose a risk to patient health. The recall involves 422 units distributed in the US and Canada.
Product
Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B; 2) ANGIOGRAPHY PACK, Pack Number DYNJ21519W; 3) NEURO ANGIO PACK, Pack Number DYNJ83941; 4) NEURO ANGIO PACK SJF-LF, Pack Number DYNJ55678; 5) NEURO PACK, Pack Number DYNJ04851Q;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1430-2025·2025-04-02
Pressure Monitoring Lines Recalled for Manufacturing Defect in Luer Fittings
Medline Industries is recalling namic medical convenience kits containing Pressure Monitoring Lines with defective female luer fittings manufactured with excess material. The defect could impair device function.
Product
namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1443-2025·2025-04-02
Medline CV Neonatal Procedure Kits Recalled Due to Syringe Quality Issues
Medline is recalling CV Neonatal Pack procedure kits (Pack Number DYNJ67356) because the plastic syringes may leak or break, potentially harming patients. The recall affects 96 units distributed nationwide and in Canada.
Product
Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0296-2025·2025-04-02
Compounded Fentanyl-Bupivacaine Epidural Injections Recalled for Sterility Failure
QuVa Pharma recalls compounded fentanyl-bupivacaine epidural injections due to lack of assurance of sterility. The recall affects 2,310 cassettes distributed nationwide.
Product
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1421-2025·2025-04-02
Baxter TruSystem 7500 Hybrid IMRIS Upper Back Adjustment Software Malfunction
A software issue in the Baxter TruSystem 7500 Hybrid MR IMRIS system prevents the upper back section from being adjusted when emergency mode is enabled. The recall affects 24 units distributed nationwide.
Product
Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1437-2025·2025-04-02
Medline Procedure Kits Recalled Due to Defective Plastic Syringe Quality Issues
Medline is recalling 9,246 units of medical procedure kits containing defective plastic syringes with leaks and breakage that may pose a risk to patient health. The kits were distributed nationwide in the US and in Canada.
Product
Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D; 2) ANGIO PACK, Pack Number DYNJ69678; 3) ANGIOGRAPHY CV RAD PACK, Pack Number DYNJ64936A; 4) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ49621C; 5) ANGIOGRAPHY PACK, Pack Number DYNJ
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1432-2025·2025-04-02
Orthofix Pillar SA Ti Spacer System Mislabeled for Anterior Height
Orthofix is recalling Pillar SA Ti Spacer System spinal implants because the product label lists an incorrect anterior height of 10mm, while the actual device measures 10.5mm. This labeling discrepancy could affect surgical planning during implantation.
Product
Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees; (2) REF 82-3700SP, 37mm W x 28mm D x 10mm H, 7 degrees; and (3) REF 82-4000SP, 40mm W x 32mm D x 10mm
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1412-2025·2025-04-02
Baxter Mobile Column TruSystem 7500 Software Defect Prevents Back Adjustment
Baxter Healthcare is recalling the Mobile column TruSystem 7500 due to a software issue that prevents the upper back section from being adjusted when emergency mode is enabled. Approximately 1,596 units distributed nationwide are affected.
Product
Baxter Mobile column TruSystem 7500, Product Code 1717023
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1433-2025·2025-04-02
NexGen LPS Flex knee prosthesis recalled for labeling inconsistency
Zimmer recalls 76 NexGen LPS Flex knee prosthesis units due to conflicting plate compatibility information on the product label.
Product
NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·25V203000·2025-04-01
Gillig Recalls 2023-2024 Low Floor Buses Due to Battery Fire Risk
Gillig is recalling 2023-2024 Low Floor transit buses because loose battery hardware may cause short circuits, increasing the risk of fire or loss of drive power.
Product
GILLIG — GILLIG LOW FLOOR
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·25V204000·2025-04-01
Bollinger Motors Recalls 2025 B4 Trucks Due to Battery Seal Defect
Bollinger Motors is recalling 2025 B4 trucks because the high-voltage battery pack may be improperly sealed, allowing liquid entry that could cause fire, shock, or loss of drive power.
Product
BOLLINGER MOTORS — BOLLINGER MOTORS B4
Category
Vehicle
Distribution
Distributed nationwide