The Recall Desk

State

Puerto Rico product recalls

72,913 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.

These figures cover only the 3,090 recalls whose distribution notice names Puerto Rico specifically. The 72,913 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

1951–1975 of 76003

  • ModerateFDA (Devices)·Z-2087-2026·2026-05-13

    One Step K in vitro diagnostic test recall for missing FDA clearance

    DFI Co., Ltd. is recalling One Step K in vitro diagnostic test devices (761 units) because they were distributed without required FDA premarket clearance or approval.

    Product
    One Step K in vitro diagnostic test REF: 81A4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2115-2026·2026-05-13

    Medline Tracheostomy Convenience Kits Sterilization Calibration Recall

    Medline Industries is recalling certain tracheostomy convenience kits and related products due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55A; 3) TRACH TOTE, Model Number:DYNJ85691
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2071-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps instructions for use correction

    Katalyst Surgical is issuing a corrective action for instructions in DEX Ophthalmic Tissue Forceps (Model DVF4014-25-S). The recall affects 80 units distributed worldwide including the US and Peru, Argentina, South Korea, Japan, and France.

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2074-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps recalled for instruction updates

    Katalyst Surgical is issuing a Field Safety Corrective Action for 670 units of DEX Ophthalmic Tissue Forceps (Model DVF4019-25) due to updates required in the instructions for use. The device was distributed worldwide.

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2112-2026·2026-05-13

    Medline Surgical Convenience Kits Recalled Due to Sterilization Calibration Issues

    Medline Industries has recalled multiple surgical convenience kits after discovering calibration issues with sterilization equipment that may impact the sterility assurance level of the devices. The kits include robotic surgery, gynecology, urology, and general surgical packs distributed nationwide.

    Product
    Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431J; 4) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 5) TOT/ GYN LITHOTO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2130-2026·2026-05-13

    Medline Surgical Packs recalled due to sterilization equipment calibration issues

    Medline Industries is recalling certain surgical packs because calibration issues with sterilization and packaging equipment may have affected sterility assurance. All recalled units were exposed to validated sterilization cycles but the calibration problems could impact sterility integrity.

    Product
    Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CS, Model Number: DYNJP8401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2073-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps 23ga Maculorhexis Forceps Recalled

    Katalyst Surgical, LLC is recalling DEX Ophthalmic Tissue Forceps, Model DVF4019-23, due to a field safety corrective action for instructions for use in DEX Forceps and Scissors. The device is distributed worldwide.

    Product
    DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2083-2026·2026-05-13

    One Step UTI in vitro diagnostic test recalled for missing FDA approval

    DFI Co., Ltd. is recalling the One Step UTI in vitro diagnostic test (REF: 3374) because it was distributed without required FDA premarket clearance or approval.

    Product
    One Step UTI in vitro diagnostic test REF: 3374
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2077-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps Require Corrective Instructions Update

    Katalyst Surgical is correcting instructions for DEX Ophthalmic Tissue Forceps (Model DVF4022-25-S) due to a field safety issue related to the Instructions for Use (IFU).

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2052-2026·2026-05-13

    Spacelabs SL Command Module patient monitor recall due to manufacturing defect

    Spacelabs Healthcare is recalling 57 SL Command Module (Model 91496) patient monitoring devices due to a manufacturing issue with the electrical leakage tester that could affect device safety and performance.

    Product
    Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2111-2026·2026-05-13

    Medline Convenience Kits recalled due to sterilization calibration issues

    Medline Industries has recalled 6,676 units of multiple Medline Convenience Kits used in gynecological and other surgical procedures due to calibration issues with sterilization equipment that may affect sterility assurance.

    Product
    Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) D&C/HYSTEROSCOPY PACK, Mo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2075-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps Field Safety Corrective Action Notice

    Katalyst Surgical is issuing a field safety corrective action for DEX Ophthalmic Tissue Forceps (Model DVF4019-25-S) due to instructions for use updates. The recall affects 645 units distributed nationwide in the US and internationally.

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0514-2026·2026-05-13

    Duloxetine Delayed-Release Capsules Recalled for Impurity Above Limit

    Ajanta Pharma Ltd. is recalling Duloxetine Delayed-Release Capsules nationwide because the active ingredient contains N-nitroso-Duloxetine impurity above the FDA-recommended limit of 0.83 ppm.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2088-2026·2026-05-13

    One Step P in vitro diagnostic test lacks FDA premarket clearance

    The One Step P in vitro diagnostic test (REF 8194) was distributed without required FDA premarket clearance or approval. The manufacturer DFI Co., Ltd. is recalling the device.

    Product
    One Step P in vitro diagnostic test REF: 8194
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2078-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps Model DVF4034-25 Instruction Recall

    Katalyst Surgical, LLC is correcting instructions for DEX Ophthalmic Tissue Forceps, Model DVF4034-25. The company has issued a field safety corrective action for the product's instructions for use.

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0516-2026·2026-05-13

    Duloxetine Delayed-Release Capsules 20 mg Recalled for Impurity

    Ajanta Pharma USA Inc. is recalling Duloxetine 20 mg delayed-release capsules (Lot PA10734, expiration June 2026) because they contain elevated levels of N-nitroso-Duloxetine impurity above the FDA-recommended limit.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2069-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps subject to Field Safety Corrective Action

    Katalyst Surgical, LLC is issuing a Field Safety Corrective Action for instructions for use (IFU) related to DEX Ophthalmic Tissue Forceps (Model DVF4005-23). The corrective action addresses a labeling issue in the product instructions.

    Product
    DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0511-2026·2026-05-13

    Buspirone Hydrochloride Tablets 5 mg Recalled for Subpotency

    Unichem Pharmaceuticals USA Inc. is recalling Buspirone Hydrochloride Tablets, USP, 5 mg because the drug is subpotent. The recall affects approximately 10,875 bottles distributed nationwide.

    Product
    BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V299000·2026-05-12

    Ford Bronco hardtop roof panel sections may separate and detach

    Ford is recalling certain 2021-2022 Bronco vehicles because Molded-In-Color hardtop roof panels may have been manufactured improperly, allowing outer sections to detach.

    Product
    FORD — FORD BRONCO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26V301000·2026-05-12

    Ford Recalls 2026 Escape and Lincoln Corsair for Park Module Failure

    Ford is recalling 2026 Escape and Lincoln Corsair vehicles because the park module may fail to lock, increasing the risk of the vehicle rolling away and causing a crash.

    Product
    LINCOLN — LINCOLN, FORD CORSAIR, ESCAPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26V297000·2026-05-12

    2026 Land Rover Range Rover vehicles recalled for faulty seat belt warning

    Jaguar Land Rover is recalling certain 2026 Range Rover Velar, Range Rover Sport, and Range Rover vehicles because the seat belt warning chime may not sound when occupants are unbuckled, increasing crash injury risk.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER, RANGE ROVER VELAR, RANGE ROVER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26V302000·2026-05-12

    Vespa Motorcycles Recalled for Missing Rearview Mirror Warning Label

    Piaggio Group Americas is recalling 285 specific Vespa models because the rearview mirrors lack the required convex mirror warning text.

    Product
    VESPA — VESPA GTV 310, PRIMAVERA 150, PRIMAVERA 50
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26E029000·2026-05-12

    Hiab Recalls Waltco MDV Series Liftgates Due to Deck Pin Failure Risk

    Hiab USA Inc. is recalling certain Waltco MDV series liftgates because deck pins may break, causing the platform to fall and increasing injury risk.

    Product
    STRUCTURE:BODY:HATCHBACK/LIFTGATE:HINGE AND ATTACHMENTS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·26V300000·2026-05-12

    Nova Bus speaker hole doors are missing the glazing DOT mark

    Nova Bus is recalling certain LFS transit buses because the driver's speaker hole door may lack the prime glazing manufacturer DOT code mark, breaching FMVSS 205.

    Product
    NOVA BUS — NOVA BUS LFS ARTIC, LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V294000·2026-05-11

    International Recalls 2026-2027 HV Trucks for Brake Release Delay

    International is recalling 2026-2027 HV vehicles because the service brake may take longer than expected to release, increasing crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL HV
    Category
    Vehicle
    Distribution
    Distributed nationwide