The Recall Desk

State

Puerto Rico product recalls

72,907 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 72,907 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

851–875 of 75997

  • SevereFDA (Devices)·Z-2550-2026·2026-07-08

    Hillrom VOLARA System patient circuits recalled for nebulizer leakage risk

    Baxter Healthcare is recalling Hillrom VOLARA System patient circuits due to reports of air and medication leakage from the nebulizer cup, which can reduce oxygen levels and prevent proper medication delivery.

    Product
    Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0651-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Loss

    CareFusion 213, LLC is recalling ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol applicators distributed nationwide because unsterilized units intended for further processing were distributed through the wrong channels.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0652-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled for Lack of Sterile Assurance

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, creating a lack of assurance of sterility.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2622-2026·2026-07-08

    Surgical Convenience Kit Recalled for Bacterial Contaminant in Alcohol Prep Pads

    Windstone Medical Packaging is recalling AMS Dr. Lewin Pack surgical convenience kits (45 units) distributed nationwide because they contain Webcol alcohol prep pads contaminated with Paenibacillus phoenicis bacteria.

    Product
    A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0692-2026·2026-07-08

    Revitaderm Wound Care Gel recalled for microbial contamination

    Revitaderm Wound Care Gel has been recalled due to microbial contamination with Lysinibacillus fusiformis and other Bacillus species. The product was distributed nationwide and consumers should stop using it.

    Product
    Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine Labs, Inc. 11037 Lockport Place Santa Fe Springs, CA 90670, NDC 63347-120-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2672-2026·2026-07-08

    GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Recall

    W. L. Gore & Associates is recalling 467 GORE TAG Thoracic Branch Endoprosthesis Side Branch Components worldwide due to risk of catheter separation during deployment.

    Product
    GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A EMEA Countries, Australia, New Zealand:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0649-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators distributed nationwide because unsterilized units intended for further processing were shipped to customers outside the intended distribution channel.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0658-2026·2026-07-08

    Accucaine Lidocaine Injection Recalled for Lack of Sterility Assurance

    Asclemed USA Inc. is recalling specific lots of Accucaine (Lidocaine HCl Injection USP, 1%) distributed nationwide due to lack of assurance of sterility. The affected product is distributed by Enovachem Pharmaceuticals.

    Product
    ACCUCAINE — ACCUCAINE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0650-2026·2026-07-08

    ChloraPrep One-Step Sterile Solution Lacks Assurance of Sterility

    CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) applicators distributed nationwide. The products were unsterilized and distributed outside the intended channel intended for further processing and sterilization.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0646-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, creating a lack of sterility assurance.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2625-2026·2026-07-08

    IntelliCuff Portable Automatic Cuff Pressure Controller Recall

    Hamilton Medical AG is recalling the IntelliCuff portable automatic cuff pressure controller due to a reported "Cuff System Leakage" error that may cause the motor to pump continuously and fail to maintain user-set cuff pressure.

    Product
    IntelliCuff, Portable automatic cuff pressure controller REF: 951001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2647-2026·2026-07-08

    RayCare 2024A SP4 Oncology System Beam Set Delivery Note Data Loss

    RayCare 2024A SP4 oncology information system may lose data or fail to notify users when beam set delivery notes are modified simultaneously or updated during treatment sessions.

    Product
    RayCare 2024A SP4. Oncology Information Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2608-2026·2026-07-08

    Medline Convenience Kits with Recalled Swan-Ganz Catheters

    Medline Industries is recalling convenience kits containing Swan-Ganz catheters due to defects in the proximal injectate lumen hub that may leak or break, risking infection, medication loss, and blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL LINE TOTE DYNJ8407
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0655-2026·2026-07-08

    Prednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance

    Lupin Pharmaceuticals is recalling Prednisolone Acetate Ophthalmic Suspension, USP, 1% due to the presence of a foreign substance. Affected lot numbers were distributed nationwide.

    Product
    PREDNISOLONE ACETATE — PREDNISOLONE ACETATE (PREDNISOLONE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1130-2026·2026-07-08

    MorningStar Farms Hot & Spicy Sausage Patties Recalled for Plastic Contamination

    Mars Snacking is recalling MorningStar Farms Hot & Spicy Sausage Patties due to potential contamination with plastic material. The recall affects 17,218 cases distributed across 40 U.S. states and Puerto Rico.

    Product
    MorningStar Farms Hot & Spicy Sausage Patties, 100% Plant Protein Vegan Sausage Patties, Net Wt. 8 oz. (228g), packaged in a resealable plastic bag with UPC 028989100948, packed 6 bags per case
    Category
    Food
    Distribution
    41 states
  • HighFDA (Devices)·Z-2670-2026·2026-07-08

    Radius VSM ECG Pre-connected Set Recalled for Incorrect Heart Rate Detection

    Masimo Corporation is recalling Radius VSM ECG pre-connected sets because the ECG electrode assembly may incorrectly detect extreme bradycardia or tachycardia and trigger false alarms on patients with normal heart rates, potentially distracting clinicians from true positive alarms and delaying treatment.

    Product
    Radius VSM ECG pre-connected Set, REF: 4842, 4695
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0661-2026·2026-07-08

    Cinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding Limits

    Cipla USA, Inc. is recalling Cinacalcet Hydrochloride 30 mg tablets due to the presence of N-nitroso-cinacalcet above the acceptable daily intake. The affected product was distributed nationwide.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0660-2026·2026-07-08

    Amphetamine extended-release capsules contain immediate-release pellets after label mix-up

    Mixed amphetamine salts extended-release capsules, 5 mg, from Lannett are being recalled because the capsules contain only immediate-release pellets. 1,392 bottles affected.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2623-2026·2026-07-08

    GC Agar Base Culture Media Reduced Recovery of Neisseria gonorrhoeae

    Remel, Inc is recalling GC Agar Base culture media because some strains of Neisseria gonorrhoeae may not be recovered or may show reduced recovery on the product.

    Product
    GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2638-2026·2026-07-08

    Baxter Head Positioning Adapter May Loosen During Patient Positioning

    Baxter Healthcare is recalling an Adapter for Head Positioning (Model 1739994) used on operating tables because it may become loose and unintentionally move during patient positioning.

    Product
    Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back Section H V U component (product code 1909813) on Baxter operating tables
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2628-2026·2026-07-08

    CRE Pro Wireguided medical device sterile packaging breach recall

    Boston Scientific Corporation is recalling the CRE Pro Wireguided 10-12mm 240cm device due to potential sterile breach of the pouches in which devices are packaged. The affected product has been distributed worldwide.

    Product
    CRE Pro Wireguided 10-12mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2611-2026·2026-07-08

    Medline Convenience Kits with Recalled Swan-Ganz Catheters Nationwide

    Medline is recalling convenience kits containing Swan-Ganz catheters with a defective proximal injectate lumen hub that may leak, break, or cause infection and blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2626-2026·2026-07-08

    Boston Scientific CRE Pro Wireguided catheters recalled for packaging

    Boston Scientific is recalling CRE Pro Wireguided 6-8mm 240cm catheters worldwide due to a potential sterile breach in the packaging pouches, which could compromise device sterility.

    Product
    CRE Pro Wireguided 6-8mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2642-2026·2026-07-08

    ARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall

    Siemens Medical Solutions is recalling 119 units of the ARTIS icono ceiling (Model 11328100) due to potential loss of movement capability when the detector lift height is adjusted to its maximum or minimum limits.

    Product
    ARTIS icono ceiling. Model Number: 11328100.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2637-2026·2026-07-08

    CRE Wireguided 18-20mm 240cm medical devices recalled for sterile breach

    Boston Scientific Corporation is recalling CRE Wireguided 18-20mm 240cm devices worldwide due to a potential sterile breach of the pouches in which the devices are packaged.

    Product
    CRE Wireguided 18-20mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide