The Recall Desk

State

Pennsylvania product recalls

72,820 recalls have nationwide distribution and so reach Pennsylvania. 11,910 additional recalls listed Pennsylvania specifically in their distribution scope.

What the numbers show

Total
11,910
Critical
1,922
Severe
2,864
Most recent
2026-09-02

Of the 11,910 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 2,864 (24%) are Severe.

These figures cover only the 11,910 recalls whose distribution notice names Pennsylvania specifically. The 72,820 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

451–475 of 84730

  • CriticalFDA (Devices)·Z-2735-2026·2026-08-05

    ResMed Astral 100/150 Ventilators Recalled Due to Electrolyte Leakage Risk

    ResMed is recalling Astral 100/150 ventilators because supercapacitor electrolyte leakage can damage the charger chip, trigger a fail-safe state, and interrupt ventilation therapy.

    Product
    Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2819-2026·2026-08-05

    Medical Convenience Kits Recalled Over Lidocaine Injection Supplier Quality Issues

    Windstone Medical Packaging is recalling 15 AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP due to supplier quality issues reported by Elevaris Medical Devices Inc.

    Product
    AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2809-2026·2026-08-05

    Medtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722

    Medtronic Perfusion Systems is recalling EOPA Elongated One-Piece Arterial Cannula Model 77722 due to potential pinhole leaks in the wire-wound body during use.

    Product
    EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2807-2026·2026-08-05

    Medtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522

    Medtronic Perfusion Systems is recalling EOPA Elongated One-Piece Arterial Cannula (Model 77522) due to potential pinhole leaks in the wire-wound body during use.

    Product
    EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2811-2026·2026-08-05

    Arterial Cannula Recall: EOPA 3D 22FR May Develop Pinhole Leaks During Bypass

    Medtronic is recalling EOPA 3D Arterial Cannula 22FR because pinhole leaks may occur during cardiopulmonary bypass, potentially causing hypovolemia, vessel injury, hypotension, ischemia, and organ dysfunction.

    Product
    EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2824-2026·2026-08-05

    GEM Premier 5000 Blood Analyzer Recalled Over Bar Code Reader Patient ID Risk

    Instrumentation Laboratory is recalling the GEM Premier 5000 blood analyzer system because bar code reader wands may assign patient results to the wrong patient ID. The FDA has classified this as a Class II recall.

    Product
    Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2652-2026·2026-08-05

    Philips Ingenuity CT Scanners Recalled Due to Bolus Tracking Trigger Issue

    Philips is recalling 182 Ingenuity CT systems in the US because the clinical scan may not trigger automatically after Bolus Tracking, potentially causing patient rescan and extra radiation.

    Product
    Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2825-2026·2026-08-05

    GEM Premier 5000 Blood Analyzer Recalled Over Bar Code Reader Patient ID Risk

    Instrumentation Laboratory is recalling the GEM Premier 5000 portable blood analyzer system because bar code reader wands may assign patient results to the wrong patient ID. The recall affects 21 units distributed nationwide.

    Product
    Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2795-2026·2026-08-05

    Permobil M3 Corpus Power Wheelchair Recalled Over Firmware Stability Issue

    Permobil is recalling M3 Corpus Power Wheelchairs with firmware version 1.26.2 because the firmware lacks a speed restriction when the seat lift exceeds 50 mm, which may cause falls or tip-overs.

    Product
    Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF:120031, Model version 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1191-2026·2026-08-05

    DQ Chocolate Reduced Fat Ice Cream Mix Recalled Due to Metal Shavings

    Galliker Dairy Co. is recalling 74 cases of DQ Chocolate Reduced Fat Ice Cream Mix because metal shavings were found in the product. The recalled mix has code JUN1226 and was distributed in PA, DE, NJ, MD, and NY.

    Product
    DQ Chocolate Reduced Fat Ice Cream Mix, 5 GAL (18.9L). Keep refrigerated.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2822-2026·2026-08-05

    Bar Code Reader Wands for GEM Premier Blood Analyzers Recalled Due to Misidentification Risk

    Instrumentation Laboratory is recalling Bar Code Reader (BCR) wands used with GEM Premier 5000 and 7000 systems because they may assign patient results to the wrong patient ID.

    Product
    Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the GEM Premier 7000. portable blood analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2821-2026·2026-08-05

    Bar Code Reader Wands for GEM Premier Blood Analyzers Recalled Due to Misidentification Risk

    Instrumentation Laboratory is recalling Bar Code Reader (BCR) wands used with GEM Premier 5000 and 7000 systems because they may assign patient results to the wrong patient ID.

    Product
    GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable blood analyzer system. Affected Accessory: Bar Code Reader (BCR) Wand Part No. 00024015859
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2833-2026·2026-08-05

    Stryker Hoffmann II Connecting Rod Micro May Crack After Cleaning and Sterilization

    Stryker GmbH is recalling Stryker Hoffmann II Connecting Rod Micro 3 x 150mm due to the potential for the rods to crack following cleaning and sterilization processes.

    Product
    Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2827-2026·2026-08-05

    Stryker Hoffmann II Connecting Rod Micro Recalled Due to Potential Cracking

    Stryker is recalling Hoffmann II Connecting Rod Micro 3 x 30mm (catalog 50796030) because the rods may crack after cleaning and sterilization. FDA has classified this as Class II.

    Product
    Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2826-2026·2026-08-05

    Blood Analyzer Bar Code Reader May Assign Patient Results to Incorrect Patient ID

    Instrumentation Laboratory is recalling certain GEM Premier 5000 blood analyzer systems because the bar code reader wand may assign patient results to the wrong patient ID.

    Product
    Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2829-2026·2026-08-05

    Stryker Hoffmann II Connecting Rod Micro May Crack After Cleaning and Sterilization

    Stryker GmbH is recalling Stryker Hoffmann II Connecting Rod Micro 3 x 50mm due to a potential risk of the rods cracking after cleaning and sterilization.

    Product
    Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2805-2026·2026-08-05

    Permobil Recalls M5 Corpus Power Wheelchairs Due to Firmware Drive Inhibit Issue

    Permobil Inc. is recalling 715 M5 Corpus Power Wheelchairs (REF 120032) because firmware versions 1.27 through 1.57 lack drive inhibit logic, which may allow driving under restricted conditions and cause instability.

    Product
    M5 Corpus Power Wheelchair REF,120032
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2823-2026·2026-08-05

    Portable Blood Analyzer System Recalled Due to Barcode Reader Misidentification Risk

    Instrumentation Laboratory is recalling GEM Premier 5000 portable blood analyzer systems because BCR wands may assign patient results to an incorrect patient ID. FDA classifies this as Class II.

    Product
    Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2802-2026·2026-08-05

    Medical convenience kits recalled due to potential endotoxin level variability

    Windstone Medical Packaging, Inc. is recalling specific lots of AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits because of potential unexpected variability in endotoxin levels.

    Product
    AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack Number AMS13574A; 2) ACDF/Fusion Pack, Pack Number AMS14710B; 3) Spine Pack, Pack Number AMS14991A; 4) Spine Pack, Pack Number AMS14991B; 5) Spinal Pack, Pack Number AMS16278;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2820-2026·2026-08-05

    OsteoBallast and Ballast bone graft extenders recalled due to insufficient material volume

    IsoTis OrthoBiologics, Inc. is recalling OsteoBallast and Ballast bone graft extenders because they may contain less demineralized bone matrix than intended.

    Product
    OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2801-2026·2026-08-05

    Neurological Sponges Recalled Due to Potential Variability in Endotoxin Levels

    Medicom is recalling specific lots of Ritmed Neurological Sponges (Models 55992C to 55998C) because of potential unexpected variability in endotoxin levels.

    Product
    AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack Number AMS12195C; 2) Neuro Pack, Pack Number AMS12195D; 3) Neuro Pack, Pack Number AMS12307; 4) Neuro Spine Pack, Pack Number AMS16313; 5) Lami Kukkar Pack, Pack Number AMS17958; 6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2810-2026·2026-08-05

    Arterial Cannula Recalled Due to Risk of Pinhole Leaks During Bypass

    Medtronic is recalling 3,621 EOPA 3D Arterial Cannula DIL TIP 22FR units because pinhole leaks may occur during cardiopulmonary bypass, risking hypovolemia, vessel injury, hypotension, ischemia, and organ dysfunction.

    Product
    EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2812-2026·2026-08-05

    Medical Convenience Kits Recalled Due to Supplier Quality Issue with Lidocaine Injection

    Windstone Medical Packaging is recalling 15 AMS spinal convenience kits, lot 230451, because they contain Elevaris Lidocaine HCl injection recalled for supplier quality issues.

    Product
    AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A
    Category
    Medical Device
    Distribution
    Distributed nationwide