The Recall Desk

State

Pennsylvania product recalls

72,986 recalls have nationwide distribution and so reach Pennsylvania. 11,919 additional recalls listed Pennsylvania specifically in their distribution scope.

What the numbers show

Total
11,919
Critical
1,922
Severe
2,866
Most recent
2026-09-16

Of the 11,919 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 11,919 recalls whose distribution notice names Pennsylvania specifically. The 72,986 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

6101–6125 of 84905

  • HighFDA (Devices)·Z-2295-2025·2025-08-20

    Custom manifold kit tubing may separate and trap air in line

    Custom Manifold Kits are being recalled because high pressure tubing may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 6,327 units affected.

    Product
    Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0466-2025·2025-08-20

    Variety paleta 16-count packs recalled over cream ingredient missing milk source

    La Michoacana Variety Paletas, 16-count 44 oz packs, are recalled nationwide because the label lists cream but does not declare milk as its source. 2,241 units are affected.

    Product
    La Michoacana Variety Paletas 16-Count 44oz UPC:7-67778-03100-0
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2285-2025·2025-08-20

    Knee tibial insert catalog number 341-16-704 recalled for mislabeled size or side

    Enovis is recalling 18 EMPOWR 3D Knee tibial inserts, catalog number 341-16-704, lot 148T1057, because the implants carry incorrect size or side labeling.

    Product
    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0587-2025·2025-08-20

    Glenmark carvedilol 12.5 mg tablets exceed the nitrosamine impurity limit

    Carvedilol Tablets USP 12.5 mg from Glenmark are being recalled because N-Nitroso Carvedilol Impurity-1 was observed above the FDA-recommended limit of not more than 4.0 ppm. 17,496 bottles affected.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0582-2025·2025-08-20

    Metoprolol tartrate 100 mg tablets exceed the nitrosamine daily intake level

    Metoprolol Tartrate Tablets USP 100 mg distributed by Westminster Pharmaceuticals are being recalled because N-nitroso-metoprolol was present above the established Acceptable Daily Intake level. 4,456 bottles affected.

    Product
    Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-355-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2287-2025·2025-08-20

    Neurostimulator patient controllers recalled over cable disconnect errors interrupting stimulation output

    Sparrow Ascent Patient Controllers are recalled because a manufacturing issue may produce a cable disconnect error message and interrupt stimulation output. 78 units are affected.

    Product
    Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2286-2025·2025-08-20

    EMPOWR 3D knee tibial inserts recalled over incorrect size or side labeling

    Enovis is recalling 40 EMPOWR 3D Knee tibial inserts, catalog number 342-16-707, because the implants carry incorrect size or side labeling.

    Product
    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0468-2025·2025-08-20

    Mini variety paletas recalled because label lists cream without declaring milk

    Helados Mexico Minis Variety Paletas, 12-count 18 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 643,519 units are affected.

    Product
    Helados Mexico Minis Variety Paletas 12-Count 18oz UPC: 6-82082-11215-6
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0446-2025·2025-08-20

    Lithium orotate 20 mg product recalled after failing labeled potency testing

    Lithium Orotate 20 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency, following a recall by the ingredient supplier.

    Product
    Lithium Orotate, 20MG, Distributed by Enjoy Nutrition, LLC. UPC#: none
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2292-2025·2025-08-20

    Bartels Legionella urinary antigen kits may contain particulate matter

    Bartels ELISA Legionella Urinary Antigen kits are being recalled because two lots have the potential to contain particulate matter. 968 kits are affected.

    Product
    Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0445-2025·2025-08-20

    Lithium orotate 10 mg product recalled for failing labeled potency standard

    Lithium Orotate 10 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency, following a recall by the ingredient supplier.

    Product
    Lithium Orotate, 10MG, Distributed by Enjoy Nutrition, LLC. UPC#: 702730894033, 702730894057
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2321-2025·2025-08-20

    Medication dispensing cabinets recalled after reports of delayed access during override workflow

    BD is recalling 6,076 Pyxis MedBank and MedBank Mini automated dispensing cabinets after reports of delayed access to medication caused by the override and Add Item workflow.

    Product
    Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS MEDBANK MINI 3HH-1HM/169-111, BD PYXIS MEDBANK MINI 3HH-1FG/169-110, BD PYXIS MEDBANK MINI 2HM-1FM/169-109, BD PYXIS MEDBANK MINI 2HH-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0583-2025·2025-08-20

    Theophylline extended-release tablets failed dissolution at long-term stability testing

    Theophylline extended-release tablets 400 mg from Glenmark are being recalled because dissolution results at the long-term shelf life stability interval did not comply with L3 stage criteria. 22,656 bottles affected.

    Product
    THEOPHYLLINE — THEOPHYLLINE (THEOPHYLLINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0444-2025·2025-08-20

    Lithium orotate 5 mg product recalled after failing to meet labeled potency

    Lithium Orotate 5 mg distributed by Enjoy Nutrition, LLC is recalled nationwide for failing to meet its labeled potency, following a recall by the ingredient supplier.

    Product
    Lithium Orotate, 5MG, Distributed by Enjoy Nutrition, LLC. UPC#: 702730893968, 702730894064
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2289-2025·2025-08-20

    Plastic trial heads carry inconsistent size terminology and color coding

    Plastic Trial Head Brown with 7 mm neck length is being recalled because of inconsistent size terminology and colour coding used on the labeling. 17 units are affected.

    Product
    Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2324-2025·2025-08-20

    Anorectal manometry kit outer label shows the manufacturing date as expiry

    Zvu Anorectal Manometry Procedure Kits are being recalled because the outer kit label carries an incorrect expiration date, with the manufacturing date used in its place. 8 kits are affected.

    Product
    Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0443-2025·2025-08-20

    Lithium orotate 2.5 mg product recalled for failing labeled potency specification

    Lithium Orotate 2.5 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency. The action follows a recall by the ingredient supplier.

    Product
    Lithium Orotate, 2.5MG, Distributed by Enjoy Nutrition, LLC. UPC#: 719318414002; 709750005289
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2288-2025·2025-08-20

    Prosthesis heads carry inconsistent size terminology and color coding on labeling

    Prosthesis Head B, 28 mm with 7 mm neck length, is being recalled because of inconsistent size terminology and colour coding used on the labeling. 46 units are affected.

    Product
    Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0442-2025·2025-08-20

    Lithium orotate 1 mg product recalled for failing labeled potency requirement

    Lithium Orotate 1 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency, following a recall by the ingredient supplier.

    Product
    Lithium Orotate, 1MG, Distributed by Enjoy Nutrition, LLC. UPC#: 717340952714
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0584-2025·2025-08-20

    Belsomra 10 mg tablets failed dissolution, which may delay sleep onset

    Belsomra (suvorexant) 10 mg tablets are being recalled because of failed dissolution specifications, with potential for delayed release of the drug and delayed onset of sleep. 51,320 cartons affected.

    Product
    BELSOMRA — BELSOMRA (SUVOREXANT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2298-2025·2025-08-20

    Ultra IABP catheter kits carry indications not reviewed by the FDA

    Insightra Ultra IABP Catheter Kits are being recalled because the device carries indications and compatibility claims not reviewed by the FDA, and its instructions are inconsistent with product training.

    Product
    Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Software Version: Not applicable Product Description: The Insightra Ultra IABP Catheter Kit is a 7 French catheter available wi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V531000·2025-08-19

    Triumph Daytona 660 engines can fail from disrupted oil flow

    Triumph is recalling certain 2024-2025 Daytona 660 motorcycles because the engine may fail due to internal damage caused by a disruption of oil flow.

    Product
    TRIUMPH — TRIUMPH DAYTONA 660
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V530000·2025-08-18

    2026 RAM Trucks Instrument Panel Cluster Warning Light Malfunction

    Chrysler is recalling certain 2026 RAM 2500, 3500, 4500 Cab Chassis, and 5500 Cab Chassis vehicles because the instrument panel may display an incorrect brake system warning light, potentially failing to alert drivers to critical safety information.

    Product
    RAM — RAM 4500, 5500, 3500, 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide