The Recall Desk

State

Pennsylvania product recalls

20,431 recalls have nationwide distribution and so reach Pennsylvania. 0 additional recalls listed Pennsylvania specifically in their distribution scope.

About recalls in Pennsylvania

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Pennsylvania consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

17176–17200 of 20431

  • ModerateFDA (Devices)·Z-1110-2022·2022-05-25

    Documentation errors recalled in HeartWare HVAD instructions and manuals

    Medtronic is recalling instruction materials for the HeartWare HVAD ventricular assist device due to errors and inconsistencies in product documentation.

    Product
    Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are dist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0880-2022·2022-05-25

    Nitrofurantoin Capsules 100 mg recalled for failed dissolution specifications

    American Health Packaging is recalling Nitrofurantoin Capsules 100 mg due to dissolution failure. The drug release results were above specification. No illnesses have been reported.

    Product
    Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1080-2022·2022-05-25

    EXALT Model D Single-Use Duodenoscope Updated Guidance on Perforation Risk

    Boston Scientific updated instructions for the EXALT Model D Single-Use Duodenoscope to address the known risk of duodenal perforation and provide best clinical practices for proper insertion, advancement, and removal of the device.

    Product
    EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·22135·2022-05-19

    Hover-1 Superfly Hoverboards Recalled Due to Fall and Injury Hazards

    DGL Group is recalling approximately 93,000 Hover-1 Superfly Hoverboards sold between October 2020 and October 2021 at Best Buy due to a software malfunction that causes uncontrolled momentum when the rider is not actively controlling the board.

    Product
    Hover-1 Superfly Hoverboards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·22748·2022-05-19

    Moderne Glass Company Recalls 15-Ounce Coffee Cups for Burn Hazard

    Moderne Glass Company is recalling about 2,500 ceramic coffee cups that can crack or break when hot water is poured into them, posing a burn hazard. No injuries have been reported. Consumers should stop using the cups immediately and contact the company for a refund.

    Product
    Coffee cups
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1009-2022·2022-05-18

    FDA Recalls Accula SARS-CoV-2 Test for False Positive Risk

    Mesa Biotech is recalling approximately 6,162 units of the Accula SARS-CoV-2 Test due to an increased risk of false positive results, which could delay correct diagnosis and treatment.

    Product
    Accula SARS-CoV-2 Test, REF: COV4100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0856-2022·2022-05-18

    SyrSpend SF Suspending Base Recalled for Burkholderia Contamination

    Fagron is recalling SyrSpend SF Suspending Base, Cherry Flavored (NDC 51552-1123-5 and 51552-1123-9) due to contamination with Burkholderia gladioli. This FDA Class I recall affects medication used in compounding.

    Product
    SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51552-1123-9), Rx Only, Manufactured for Fagron, Inc., St. Paul, MN 55120.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1042-2022·2022-05-18

    Medtronic IN.PACT Admiral balloon catheters recalled for damaged packaging

    Medtronic is recalling IN.PACT Admiral paclitaxel-coated balloon catheters due to damaged packaging that may result in loss of sterility, affecting approximately 6,035 units worldwide.

    Product
    Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04008013P ADM04008013P ADM04008013P ADM04012013P ADM04015013P ADM04015013P ADM04025013P ADM05004013P ADM05004013P ADM05006013P ADM05006013P ADM05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1052-2022·2022-05-18

    Prothrombin Time Reagent Recalled for Quality Control Failures

    Instrumentation Laboratory is recalling HemosIL ReadiPlasTin due to variable and out-of-specification quality control results. The manufacturer is removing all affected lots and providing customers with an alternative reagent.

    Product
    HemosIL ReadiPlasTin, Part No. 0020301400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1050-2022·2022-05-18

    FDA Recalls Unauthorized COVID-19 Antigen Rapid Test Kits

    USA Medical, LLC distributed 2055 COVID-19 antigen test kits nationwide. The tests did not receive FDA Emergency Use Authorization nor were they cleared or approved for commercial distribution.

    Product
    Diagnostic Kit SARS-cCo V Antigen Rapid Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1037-2022·2022-05-18

    Surgical Device Kits Recalled Due to Improper Sterilization Process

    American Contract Systems is recalling ACS Arthroscopy, Knee, and Hand surgical kits because they were sterilized using a higher than specification ethylene oxide concentration.

    Product
    1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0854-2022·2022-05-18

    Xanax XR Extended-Release Tablets Recalled for Failed Dissolution Specifications

    Viatris Inc recalls Xanax XR (alprazolam) 3 mg extended-release tablets due to failed dissolution specifications. Affected tablets may not break down properly, potentially reducing medication effectiveness.

    Product
    Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Fizer Inc, NY, NY 10017, NDC 0009-0068-07.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1049-2022·2022-05-18

    Bronchovideoscope Recall for Updated Sterilization and Reprocessing Instructions

    Olympus bronchovideoscopes are recalled due to updates required for proper sterilization and reprocessing procedures. Healthcare providers must follow new instructions for chemical disinfection and ETO gas sterilization.

    Product
    BF-1TQ180: EVIS EXERA II Bronchovideoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1075-2022·2022-05-18

    X-ray Imaging Systems Have Reversed Spine Positioning Labels

    Shanghai United Imaging's digital X-ray systems may display reversed spine positioning labels, potentially causing misdiagnosis and unnecessary repeat radiation exposure for patients.

    Product
    Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1057-2022·2022-05-18

    Chemotherapy Infusion Bag Adaptor May Disconnect and Spill Hazardous Drugs

    Simplivia Healthcare is recalling OnGuard2 CSTD Bag Adaptors because they may disconnect from infusion bags, potentially spilling hazardous medications.

    Product
    OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1072-2022·2022-05-18

    Radial Head Replacement System implant: contraindications added to safety instructions

    Synthes has updated safety instructions for its Radial Head Replacement System implant with absolute contraindications for use in patients with infection, sepsis, or osteomyelitis. The FDA has classified this as a Class II recall.

    Product
    Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 24mm in length.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0860-2022·2022-05-18

    Esomeprazole magnesium delayed-release capsules recalled for impurity specification failure

    Mylan Institutional Inc. is recalling Esomeprazole Magnesium Delayed-Release Capsules 20 mg due to failed impurity specifications detected during stability testing. 555 cartons of affected lots were distributed nationwide.

    Product
    Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-009-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1038-2022·2022-05-18

    ACS IR Angio Pack Sterilization Process Defect Recall

    The ACS IR Angio Pack from American Contract Systems, Inc. was sterilized using ethylene oxide at higher than specification concentration. No illnesses or injuries have been reported.

    Product
    ACS IR - Angio Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1073-2022·2022-05-18

    Daavlin 1 Series CX Phototherapy Units Recalled for Software Dosing Error

    Daavlin is recalling 1 Series CX phototherapy units due to a software bug that swaps calibration distance settings when resuming interrupted treatments, resulting in incorrect dosing.

    Product
    1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305-4 120-240V 50/60Hz, item # 06OS0004CX6], [1 Ser CX 311-4 120-240V 50/60Hz CE, item # 807OS0004CX5], [1 Ser CX 311-4 120-240V 50/60Hz, item
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1047-2022·2022-05-18

    Bronchovideoscope Reprocessing Instructions Updated Due to Sterilization Concerns

    Olympus is issuing updated instructions for reprocessing its EVIS EXERA bronchovideoscopes to ensure proper sterilization and disinfection procedures. Improper reprocessing could compromise device safety.

    Product
    BF-3C160: EVIS EXERA Bronchovideoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1036-2022·2022-05-18

    Spine Surgery Instrument Sets Recalled for Sterilization Defect

    American Contract Systems is recalling ACS Spine Pack and ACS Lumbar/Back Set Up Tray surgical instrument sets due to improper sterilization with excess ethylene oxide. The affected sets were distributed in Illinois, Missouri, Nebraska, and Texas.

    Product
    1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1071-2022·2022-05-18

    TMJ Arthroscopy Drape incorrectly labeled latex-free when containing latex

    Microtek Medical Inc. is recalling TMJ Arthroscopy Drapes that contain latex but were mislabeled as latex-free, posing an allergic reaction risk to patients and healthcare workers with latex sensitivities.

    Product
    TMJ Arthroscopy Drape, 85''x 96''
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1054-2022·2022-05-18

    KARL STORZ Nasopharyngolaryngoscope Disinfection Failure Affects 14 States

    The FDA is recalling KARL STORZ Slim Nasopharyngolaryngoscope models 11001RD1 and 11001RDK1 because they fail to achieve adequate disinfection, potentially allowing microorganisms to persist on the device and transmit between patients.

    Product
    11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)
    Category
    Medical Device
    Distribution
    Distributed nationwide