The Recall Desk

State

Pennsylvania product recalls

72,940 recalls have nationwide distribution and so reach Pennsylvania. 11,918 additional recalls listed Pennsylvania specifically in their distribution scope.

What the numbers show

Total
11,918
Critical
1,922
Severe
2,866
Most recent
2026-09-09

Of the 11,918 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 11,918 recalls whose distribution notice names Pennsylvania specifically. The 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

4501–4525 of 84858

  • HighFDA (Devices)·Z-0519-2026·2025-11-26

    Breast and plastics packs recalled over smoke pencils that may activate

    Medline is recalling 4,214 breast, abdominoplasty and plastics convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3) PLASTIC PACK, REF DYNJ00264M; 4) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947L; 5) BREAST ABDOMINOPLASTY MB PK-LF, REF DYNJ0428947M; 6) AUGMENTATION #
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0505-2026·2025-11-26

    Heart pump kits recalled over corrosion at the backup battery connector

    Thoratec is recalling 29,059 HeartMate 3 Left Ventricular System kits because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.

    Product
    Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS; 106524 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist Syste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0520-2026·2025-11-26

    Basin packs recalled over smoke pencils that may activate unprompted

    Medline is recalling 1,921 basin convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ37698L; 2) BASIN PACK, REF DYNJ50123D; 3) MAJOR BASIN PACK, REF DYNJ59816A; 4) OSC BASIN PACK, REF DYNJ68217A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0504-2026·2025-11-26

    Luer tip caps recalled after trays failed routine biocompatibility testing

    Becton Dickinson is recalling 4,180,000 BD Luer Tip Caps after internal testing confirmed that certain device trays failed routine biocompatibility testing.

    Product
    BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0515-2026·2025-11-26

    Breast biopsy packs recalled over smoke pencils that may activate

    Medline is recalling 301 breast biopsy and mastectomy convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREAST PACK, REF DYNJ65361A; 3) BREAST BIOPSY/MASTECTOMY, REF DYNJ908839A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2026·2025-11-26

    Hemostasis valves recalled because the valve cap may remain depressed

    Merit Medical is recalling 217,141 PhD Hemostasis Valves because a manufacturing defect can leave the valve cap depressed, leading to potential leakage and possible hemorrhage.

    Product
    PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-0529-2026·2025-11-26

    Minor eye trays recalled over smoke pencils that may stay active

    Medline is recalling 345 Minor Eye Tray #81 convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) MINOR EYE TRAY #81, REF DYNJ27466T.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0523-2026·2025-11-26

    Major vaginal surgery packs recalled over smoke pencil activation defect

    Medline is recalling 424 major vaginal surgery convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0503-2026·2025-11-26

    Oncology software recalled because appended medication orders may mismatch the schedule

    Elekta is recalling four systems running MOSAIQ Oncology Information System builds 3.1.3 through 3.2.3.0 because appended wave medication orders may not match the intended schedule.

    Product
    MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2026·2025-11-26

    Neuro and joint kits recalled over smoke pencils that may activate

    Medline is recalling 40,151 neurosurgery, back and joint convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS780147N; 3) INSTRUMENTED BACK CDS, REF CDS780148R; 4) NEURO-LAMI CDS, REF CDS780208I; 5) TOTAL HIP, REF CDS920027Y; 6) TOTAL KNEE, REF CDS940072Y; 7) TOTA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0571-2026·2025-11-26

    Blood tubes recalled after being manufactured without the gel separator

    Greiner Bio-One is recalling 1,980,000 Vacuette 8 ml serum separator tubes because some were manufactured without the gel separator, which could yield erroneous assay results.

    Product
    Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0522-2026·2025-11-26

    Neuro shunt and laminectomy kits recalled over smoke pencil activation defect

    Medline is recalling 1,315 neurosurgery convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; 2) ACDF CDS, REF CDS941061M; 3) NEURO PACK-LF, REF DYNJ0038440C; 4) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S; 5) NEURO-ORTHO EXTRAS, REF DYNJ44882M; 6) LAMINECTOMY, REF DYNJ903870F.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0516-2026·2025-11-26

    Head and neck ENT kits recalled over smoke pencil activation defect

    Medline is recalling 3,078 head and neck, ENT and thoracotomy convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2) HEAD AND NECK, REF CDS984259P; 3) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F; 4) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I; 5) THORACOTOMY HARPER PACK-LF, REF DYNJ0161795F; 6) MAJOR ENT MZ PAC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0540-2026·2025-11-26

    Bone void implants recalled over an incorrect product name on packaging

    Berkeley Advanced Biomaterials is recalling 62 Tribio Implants 7.5mm x 40mm because the outer packaging carries an incorrect product name.

    Product
    Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0526-2026·2025-11-26

    Caesarean section kits recalled over smoke pencils that may activate

    Medline is recalling 11,032 C-section convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-SECTION CDS, REF CDS985282F; 4) C-SECTION PACK, REF DYNJ02577D; 5) C-SECTION PACK-LF, REF DYNJ0536924U; 6) C-SECTION PACK-LF, REF DYNJ0551169V; 7) C-SECT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0573-2026·2025-11-26

    Non Siemens imaging catheters recalled after exceeding validated reprocessing cycles

    Sterilmed is recalling six reprocessed ACUSON AcuNav diagnostic ultrasound catheters, the variant not for use with Siemens systems, because they were reprocessed beyond validated cycles.

    Product
    Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135910 Software Version: N/A Product Description: ACUSON, CATHETER
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0167-2026·2025-11-26

    Foaming hand soap recalled over contamination found at the manufacturing facility

    DermaRite Industries is recalling 576 containers of Hand-E-Foam because it was made at the same facility where other products and lots were found to be contaminated.

    Product
    Hand-E-Foam, Benzethonium Chloride 0.20%, packaged in a) 236mL (NDC 61924-102-08) and b) 1000 mL (NDC 61924-102-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0550-2026·2025-11-26

    Plasma separator tubes recalled over unvalidated manufacturing processes

    ASP Global is recalling 9,150 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with lithium heparin and plasma separator gel, over an inadequate quality system.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7221 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0168-2026·2025-11-26

    Antimicrobial foam soap recalled over contamination found at the manufacturing facility

    DermaRite Industries is recalling 15,267 cartridges of KleenFoam Antimicrobial Foam Soap because it was made at the same facility where other products were found contaminated.

    Product
    KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0556-2026·2025-11-26

    Untreated hematocrit tubes recalled over an inadequate quality system

    ASP Global is recalling 209,000 SAFE-T-FILL microhematocrit capillary tubes, 50 microlitres untreated, over an inadequate quality system with unvalidated processes.

    Product
    SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product Description: A clear, plastic capillary blood collection tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0545-2026·2025-11-26

    Red serum separator tubes recalled over unvalidated manufacturing processes

    ASP Global is recalling 50,050 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with clot activator and serum separator gel, over an inadequate quality system.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7120 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0549-2026·2025-11-26

    Plasma separator microtubes recalled over an inadequate quality system

    ASP Global is recalling 49,000 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with lithium heparin and plasma separator gel, over an inadequate quality system.

    Product
    AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7220 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0553-2026·2025-11-26

    Sodium fluoride microtubes recalled over an inadequate quality system

    ASP Global is recalling 2,100 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with sodium fluoride, over an inadequate quality system.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
    Category
    Medical Device
    Distribution
    Distributed nationwide