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.

3501–3525 of 84858

  • HighFDA (Devices)·Z-1257-2026·2026-02-11

    Urinalysis test strips recalled over missing FDA premarket clearance

    Changchun Wancheng Bio-Electron is recalling 91,366 units of LotFancy Urinary Tract Infection Urine (UTI) Test Strips because tests requiring a 510(k) were distributed before they could be legally marketed.

    Product
    LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1248-2026·2026-02-11

    Subretinal injection cannulas recalled over voids in pouch seals

    Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.

    Product
    25GA Subretinal Injection Cannula VS0220.25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1304-2026·2026-02-11

    pTau 217 plasma controls recalled over falsely elevated ratio results

    Fujirebio Diagnostics is recalling 148 units of Lumipulse pTau 217 Plasma Controls because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.

    Product
    Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personn
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1256-2026·2026-02-11

    Scleral IOL markers recalled over voids in sterile pouch seals

    Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.

    Product
    Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1266-2026·2026-02-11

    Vaginal pH tests recalled over missing FDA premarket clearance

    Changchun Wancheng Bio-Electron is recalling 3,000 units of Vivoo Vaginal pH Test because tests requiring a 510(k) were distributed before they could be legally marketed.

    Product
    Vivoo Vaginal pH Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2026·2026-02-11

    Electrosurgical knives recalled over tip breakage from overheating and burning

    Olympus is recalling the Single Use Electrosurgical Knife KD-640L because deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

    Product
    Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1246-2026·2026-02-11

    Oertli laser probes recalled over voids in sterile pouch seals

    Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.

    Product
    Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1223-2026·2026-02-11

    Electrosurgical knife KD-645 recalled over tip breakage during use

    Olympus is recalling 3,361 Single Use Electrosurgical Knife KD-645 units because deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

    Product
    Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1258-2026·2026-02-11

    Ketone and urinalysis strips recalled over missing premarket clearance

    Changchun Wancheng Bio-Electron is recalling 32,500 units covering The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips because tests requiring a 510(k) were distributed before they could be legally marketed.

    Product
    The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1267-2026·2026-02-11

    Vivoo sodium and hydration tests recalled over missing premarket clearance

    Changchun Wancheng Bio-Electron is recalling 3,300 units of Vivoo Sodium Test because tests requiring a 510(k) were distributed before they could be legally marketed.

    Product
    Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1250-2026·2026-02-11

    Internal delivery devices recalled over voids in sterile pouch seals

    Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.

    Product
    Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1236-2026·2026-02-11

    Susceptibility test cards recalled over false resistant antibiotic results

    bioMerieux is recalling 2,668,954 VITEK 2 Gram-negative Susceptibility Cards over a potential risk of quality control failures and false resistant antibiotic results.

    Product
    VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 42364
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0479-2026·2026-02-11

    Lemon pie sea moss gel recalled over potential Clostridium botulinum

    Diva Fam is recalling Sea Moss Gel Superfood in the Lemon Pie flavour over potential Clostridium botulinum contamination.

    Product
    Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Lemon Pie- UPC# 5061033691271
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1247-2026·2026-02-11

    Disposable forceps and cannulas recalled over voids in pouch seals

    Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.

    Product
    Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0305-2026·2026-02-11

    Trazodone tablets recalled over the presence of foreign tablets

    Granules Pharmaceuticals is recalling 71,424 bottles of Trazodone Hydrochloride, USP 50 mg, over the presence of foreign tablets or capsules.

    Product
    TRAZODONE HYDROCHLORIDE — TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1268-2026·2026-02-11

    CleverCut sphincterotomes recalled over a skipped thermoforming step

    Olympus is recalling the CleverCut Single Use 3-Lumen Sphincterotome V, model KD-V411M-0320, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1276-2026·2026-02-11

    Sphincterotome KD-V431M-0730 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V431M-0730, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1254-2026·2026-02-11

    Illuminated depressors recalled with no reason given in the record

    Vortex Surgical is recalling the TID Pharos Illuminated Depressor, VS0801B. The reason field in the enforcement record reads only "XXX", so no hazard is stated.

    Product
    Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1231-2026·2026-02-11

    Prismaflex TPE2000 sets recalled over a deaeration chamber that may dislodge

    Vantive US Healthcare is recalling 13,760 units of the PRISMAFLEX TPE2000 SET because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.

    Product
    PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1269-2026·2026-02-11

    Sphincterotome KD-VC431Q-0720 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use Sphincterotome V (Distal Wire guided), model KD-VC431Q-0720, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0441-2026·2026-02-11

    Energy drink recalled over a label understating its caffeine content

    Fazt & Loud is recalling Lost and Found Energy, Sour Gummy Bear, because a label misprint states 150mg of caffeine when the product contains 300mg.

    Product
    Lost and Found Energy, Sour Gummy Bear, 12pck, 16oz Cans Case UPC: 850075595655 Can UPC: 850075595662 Aluminum Can Packaged
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1228-2026·2026-02-11

    Prismaflex M150 sets recalled over a deaeration chamber that may dislodge

    Vantive US Healthcare is recalling 137,576 units of the PRISMAFLEX M150 SET because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.

    Product
    PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1275-2026·2026-02-11

    Sphincterotome KD-V431M-0720 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V431M-0720, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide