The Recall Desk

State

Puerto Rico product recalls

72,936 recalls have nationwide distribution and so reach Puerto Rico. 3,090 additional recalls listed Puerto Rico specifically in their distribution scope.

What the numbers show

Total
3,090
Critical
366
Severe
625
Most recent
2026-09-02

Of the 3,090 recalls naming Puerto Rico we have scored against our rubric, 366 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 625 (20%) are Severe.

Which agencies issued them

These figures cover only the 3,090 recalls whose distribution notice names Puerto Rico specifically. The 72,936 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3326–3350 of 76026

  • ModerateFDA (Devices)·Z-1285-2026·2026-02-11

    Sphincterotome KD-411Q-0720 recalled over a skipped thermoforming step

    Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-411Q-0720, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-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-1224-2026·2026-02-11

    Prismaflex ST100 sets recalled over a deaeration chamber that may dislodge

    Vantive US Healthcare is recalling 87,436 units of the PRISMAFLEX ST100 SET US because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.

    Product
    PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1272-2026·2026-02-11

    Sphincterotome KD-V411M-0720 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-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-V411M-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
  • 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-1242-2026·2026-02-11

    NAEOTOM Alpha.Pro software applications recalled over missing FDA clearance

    Siemens is removing three software applications from two NAEOTOM Alpha.Pro CT systems because the applications have not received FDA 510(k) clearance.

    Product
    NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
    Category
    Medical Device
    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-1270-2026·2026-02-11

    Sphincterotome KD-431Q-0720 recalled over a skipped thermoforming step

    Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-431Q-0720, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-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 (Devices)·Z-1273-2026·2026-02-11

    Single use 3-lumen sphincterotomes recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-0725, 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-V411M-0725; 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-1295-2026·2026-02-11

    Sphincterotome KD-V411M-3020 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-3020, 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-V411M-3020 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-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 (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-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-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
  • ModerateFDA (Devices)·Z-1278-2026·2026-02-11

    Distal wire guided sphincterotomes recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0720, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1297-2026·2026-02-11

    Sphincterotome KD-VC411Q-0725 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0725, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; 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-1284-2026·2026-02-11

    Sphincterotome KD-VC433Q-0730 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC433Q-0730, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-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 c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·26T006000·2026-02-10

    Vee Tyre Recalls Taiga AT Tires Due to Sidewall Separation Risk

    Vee Tyre is recalling specific Taiga AT tires because the sidewall and inner liner may crack and separate, increasing the risk of a crash.

    Product
    TIRES:SIDEWALL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26V076000·2026-02-10

    2024–2027 Volvo VNL (4) trucks recalled for inadequate parking brake

    Volvo Trucks is recalling certain 2024–2027 VNL (4) vehicles lacking auxiliary parking brakes, which can result in inadequate parking brake force and rollaway risk.

    Product
    VOLVO — VOLVO VNL (4)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V075000·2026-02-09

    Harley-Davidson Sportster S upper triple clamp may fracture during use

    Harley-Davidson is recalling certain 2021-2026 RH1250S Sportster S motorcycles because the upper triple clamp may fracture, which can lead to a loss of control.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON RH1250S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V074000·2026-02-08

    Oshkosh Recalls 2025-2026 NGDV Vehicles Due to Brake Pedal Defect

    Oshkosh is recalling 2025-2026 NGDV and NGDV Electric vehicles because the brake pedal mounting pin and clip may be missing, risking loss of braking ability.

    Product
    OSHKOSH — OSHKOSH NGDV, NGDV ELECTRIC
    Category
    Vehicle
    Distribution
    Distributed nationwide