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.

551–575 of 84730

  • HighFDA (Devices)·Z-2777-2026·2026-07-29

    Emano Flow Uroflowmetry App Recalled Over Biased Flow Estimates

    Emano Metrics is recalling 685 units of the Emano Flow smartphone-based acoustic uroflowmetry app (v2.0.0) because recordings captured at 48,000 Hz were processed by models trained on 44,100 Hz audio, producing systematically biased urinary flow rate and voided volume estimates.

    Product
    Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflowmetry system. Software-only device that measures urinary flow rate and voided volume from the acoustic signal of urination. No physical components. Distributed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1186-2026·2026-07-29

    Fusia Kimchi and Tofu Kimbap Recalled Due to Undeclared Fish Allergen

    GELLERT GLOBAL GROUP is recalling Fusia Asian Inspirations Kimchi & Tofu Kimbap because it contains undeclared fish.

    Product
    Fusia, Asian Inspirations, Kimchi & Tofu Kimbap, 8.1 OZ (230 g), Paper Film Wrapper, 12 packages per case , 6 ea: Kimchi & Tofu Kimbap / 6 ea Spicy Tuna with Gochujang Kimbap, Keep Frozen-Do Not Thaw .
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2784-2026·2026-07-29

    Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Material Issues

    Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. ROBOTIC CDS980523M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2779-2026·2026-07-29

    Medline Bard Silastic Foley Catheter Kits Recalled Due to Surface Contamination

    Medline is recalling 980 Bard Silastic Foley Catheter kits due to increased raw material on the catheter surface that may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2770-2026·2026-07-29

    Penumbra System RED 68 Reperfusion Catheter Recall Due to Fracture Risk

    Penumbra, Inc. is recalling its RED 68 Reperfusion Catheter due to manufacturing issues that may cause the device to fracture during use.

    Product
    Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2759-2026·2026-07-29

    ICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk

    ICU Medical is recalling specific lots of Hotline Fluid Warming Sets due to an increased likelihood of leakage from inadequate solvent application at the tubing to return connector bond.

    Product
    Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions, List Number L-70
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0721-2026·2026-07-29

    ROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns

    The FDA is recalling ROHTO DRY-AID cooling eye drops due to lack of assurance of sterility. The product was distributed nationwide in the United States.

    Product
    Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2793-2026·2026-07-29

    SafeOp Patient Interface Neuromonitoring Device Recalled Due to Software Issue

    Alphatec Spine, Inc. is recalling the SafeOp Patient Interface due to a software issue that may cause loss of electromyography functionality during surgery.

    Product
    SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2782-2026·2026-07-29

    Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Material

    Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. NON MB DAVINCI LITHOTOMY SM PK DYNJT6105
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0711-2026·2026-07-29

    LEVOTHYROXINE SODIUM Tablets Recalled Due to Subpotent Drug Content

    Major Pharmaceuticals is recalling LEVOTHYROXINE SODIUM 150 mcg tablets because some batches contain less active ingredient than labeled, potentially reducing thyroid hormone effectiveness.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2755-2026·2026-07-29

    FARADRIVE STEERABLE SHEATH CLEAR Medical Device Recall

    Boston Scientific recalls FARADRIVE STEERABLE SHEATH CLEAR due to valve damage risk that could cause air embolism during heart procedures.

    Product
    FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2771-2026·2026-07-29

    Boston Scientific TheraSphere 360 Y-90 Management Platform Software Recall Due to Calculation Error

    Boston Scientific Corporation is recalling the TheraSphere 360 Y-90 Management Platform (Model M00139509001) due to a software anomaly that may cause incorrect dose calculations.

    Product
    Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0709-2026·2026-07-29

    Levothyroxine Sodium Tablets Recalled Due to Subpotent Drug Concerns

    Major Pharmaceuticals is voluntarily recalling certain lots of Levothyroxine Sodium Tablets (75 mcg) because the medication may be subpotent.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0710-2026·2026-07-29

    Levothyroxine Sodium Tablets Recalled Due to Subpotent Drug Concerns

    Major Pharmaceuticals is voluntarily recalling Levothyroxine Sodium Tablets (125 mcg) because the medication may be subpotent.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2787-2026·2026-07-29

    Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Contamination

    Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0701-2026·2026-07-29

    Levothyroxine Sodium Tablets Recalled for Subpotency by Major Pharmaceuticals

    Major Pharmaceuticals is voluntarily recalling Levothyroxine Sodium Tablets (50 mcg) from lot N02200 due to subpotency, meaning the tablets may contain less active ingredient than labeled. Products were distributed nationwide in the USA.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2767-2026·2026-07-29

    3mensio Workstation Software Recalled Due to Inaccurate Cardiovascular Measurements

    PIE Medical Imaging B.V. is recalling 3mensio Workstation (Vascular Fenestrated) software because it may provide inaccurate cardiovascular measurements under specific conditions.

    Product
    3mensio Workstation (Vascular Fenestrated) software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0727-2026·2026-07-29

    Naropin Injection Recall Over Particulate Matter Contamination

    Fresenius Kabi is recalling 92,600 vials of NAROPIN (ropivacaine hydrochloride) injection, 0.5%, 10/2028, due to the presence of particulate matter, including hair, found in the product.

    Product
    NAROPIN — NAROPIN (ROPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2754-2026·2026-07-29

    FARADRIVE Steerable Sheath Clear IDE Recall for Air Embolism Risk

    Boston Scientific recalls 400 units of a cardiac catheter sheath due to potential air embolism risk from valve damage during preparation.

    Product
    FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2785-2026·2026-07-29

    Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Contamination

    Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. RR-DAVINCI PROSTATE ACCESSORY DYNJ63392F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2786-2026·2026-07-29

    Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Material

    Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. SM-LAPAROSCOPIC PROSTATE PAC DYNJ61206J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0716-2026·2026-07-29

    Rohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns

    Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling Rohto Cooling Eye Drops Max Strength because there is a lack of assurance regarding the product's sterility.

    Product
    Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2781-2026·2026-07-29

    Medline Urology Robotic Procedure Packs Recalled Due to Catheter Surface Contamination

    Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. UROLOGY ROBOTIC PROCEDURE PACK DYNJ0945779U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2757-2026·2026-07-29

    Boston Scientific Steerable Sheath Recall Over Hemostatic Valve Damage

    Boston Scientific is recalling its Faradrive Steerable Sheath devices due to potential hemostatic valve damage during preparation, which may cause air ingress and patient harm.

    Product
    FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01
    Category
    Medical Device
    Distribution
    Distributed nationwide