The Recall Desk

State

Puerto Rico product recalls

72,919 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 72,919 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

2201–2225 of 76009

  • ModerateFDA (Devices)·Z-1898-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure

    Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2110) because the Version 2 reprocessor connecting tube lock levers may fail prematurely. The tubes are used to reprocess endoscopes.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1893-2026·2026-04-29

    LeadCare II Blood Lead Test Kit Recall for Inaccurate Results

    Magellan Diagnostics is recalling LeadCare II Blood Lead Test Kits because certain third-party micro-collection devices may produce falsely elevated lead results, potentially causing unnecessary testing and delayed results.

    Product
    (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1883-2026·2026-04-29

    Medline convenience kits recalled over unapproved syringe design changes

    Medline is recalling convenience kits containing select 10 mL polycarbonate colored syringes because of unapproved design changes made outside the 510(k) clearance. 270,311 units are affected.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF DYNJ87052 BASIC PACK DYNJ83976 BASIC SET UP PACK DYNJ80700 CORONARY ANGI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1849-2026·2026-04-29

    Medline Medical Device Kits Recall for Loss of 510(k) Clearance

    Medline Industries is recalling certain surgical and medical kits because their 510(k) regulatory clearances for Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. About 2,609 units were distributed nationwide.

    Product
    Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D 3) CAMPUS EXTREMITY PK, Model Number: DYNJ51935A 4) FOOT -XRAY BOWL MEDCUP SPECCUP, Model Number: DYNJ68902A 5) RADIOLOGY SPINE PACK, Model Number: DYNJ806
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0498-2026·2026-04-29

    Lactated Ringers Irrigation 3000 mL Bags Recall: Sterility Concern

    B. Braun Medical Inc. is recalling Lactated Ringers Irrigation 3000 mL bags due to lack of assurance of sterility and potential leakage from the diaphragm port after foil removal.

    Product
    LACTATED RINGERS IRRIGATION — LACTATED RINGERS IRRIGATION (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0493-2026·2026-04-29

    Omega-3-Acid Ethyl Esters capsules recalled for failed capsule specifications

    The Harvard Drug Group LLC is recalling Omega-3-Acid Ethyl Esters capsules (1 gram, 50-count cartons) due to failed capsule specifications discovered during routine stability testing.

    Product
    OMEGA-3-ACID ETHYL ESTERS — OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1919-2026·2026-04-29

    IV Administration Sets Potential Backflow and Occlusion Risk

    B. Braun is correcting gravity and pump administration sets used with specific infusion pumps due to risk of medication backflow from secondary containers into primary containers and occlusion during priming.

    Product
    Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1924-2026·2026-04-29

    Flamingo Funnel Small surgical device recalled for sterilization defect

    SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Small (Model SQ20012-01) due to a manufacturing issue involving use of a non-gamma sterilization compatible drape.

    Product
    Flamingo Funnel Small, Model Number SQ20012-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1836-2026·2026-04-29

    Medline left heart kits recalled after 510(k) clearances were rescinded

    Medline is recalling a range of custom left heart and catheterization kits because the 510(k) clearances for certain control syringes, guidewires and high-pressure tubing were rescinded.

    Product
    Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026; 3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673; 4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817; 5) MTS LEFT HEART
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1880-2026·2026-04-29

    Medline Convenience Kits with Polycarbonate Syringes Recalled for Unapproved Design Changes

    Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed in the US and internationally.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DYNJ0101278I SINUS PACK DYNJ56262
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1903-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Recalled Nationwide

    Olympus Corporation recalls OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2115) due to a defect. The recall affects approximately 2,089 units distributed nationwide and internationally.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1910-2026·2026-04-29

    Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 Medical Device Recall

    Arrow International is recalling 85 units of the Arrow Echogenic Introducer Needle due to incorrect manufacturing of the liquid adhesive used in the device.

    Product
    Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1848-2026·2026-04-29

    Medline D and C Pack Kits Recalled Due to Rescinded Regulatory Clearances

    Medline Industries is recalling D and C Pack kits (Model DYNJ41254B) nationwide because regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing have been rescinded.

    Product
    Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1829-2026·2026-04-29

    Medline Namic Guidewires Recall Due to Rescinded FDA Clearance

    Medline Industries has issued a recall of Medline Namic Guidewires because their FDA 510(k) regulatory clearances have been rescinded. The affected units were distributed nationwide.

    Product
    Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM ANG S, Model Number: DYNJHWIRE105; 3) GWIRE HYDRO 0.035 260CM ANG S, Model Number: DYNJHWIRE107; 4) GWIRE HYDRO 0.035 260CM STR S, Model Number: DYNJHWIRE115;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1925-2026·2026-04-29

    Flamingo Funnel Medium surgical device recall due to sterilization incompatibility

    SurgiSmoke Solutions is recalling certain lots of Flamingo Funnel Medium (Model SQ20012-02) because a non-gamma sterilization compatible drape was used during manufacturing, which could affect device safety.

    Product
    Flamingo Funnel Medium, Model Number SQ20012-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1895-2026·2026-04-29

    LeadCare Ultra Blood Lead Test Kit Recalled for False Positive Results

    Magellan Diagnostics is recalling the LeadCare Ultra Blood Lead Test Kit (Catalog Number 70-8098) because use with certain third-party micro-collection devices may produce unexpectedly elevated and false positive results, potentially causing delayed diagnosis and unnecessary additional testing.

    Product
    LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead Co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1885-2026·2026-04-29

    Medline 10mL Polycarbonate Colored Syringes Kits Recalled for Unapproved Design Changes

    Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects syringes distributed worldwide, including the US, Canada, Panama, and Barbados.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ908706D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1841-2026·2026-04-29

    Medline Breast Pack Kit regulatory clearance rescinded by FDA

    The FDA has rescinded the regulatory clearance for Medline's Breast Pack Kit (Model DYNJ66777D) because certain Control Syringes, Guidewires, and High-Pressure Tubing components no longer meet regulatory standards.

    Product
    Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1828-2026·2026-04-29

    CUSA Clarity C7000 Ultrasonic Surgical Aspirator Touch Screen Unresponsiveness

    Integra LifeSciences is recalling the CUSA Clarity C7000 Console (Software Version 2.1.1.909) due to a software issue that renders the touch screen unresponsive during surgical use.

    Product
    CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0490-2026·2026-04-29

    Monsel's Solution ferric subsulfate vials recalled for incorrect expiration date printing

    Premier Dental Products is recalling Monsel's Solution (ferric subsulfate) 8 mL vials because the expiration date on the vial itself is printed with an extra digit (2709114 instead of 270914). The carton expiration date is correct.

    Product
    MONSELS SOLUTION — MONSELS SOLUTION (FERRIC SUBSULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V268000·2026-04-28

    Ford Ranger and Bronco front seat pivot bolts may dislodge

    Ford is recalling certain 2024-2026 Ranger and Bronco vehicles because the front seat frame height-adjust pivot bolt may be loose or dislodged. 179,698 vehicles are affected.

    Product
    FORD — FORD BRONCO, RANGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V269000·2026-04-28

    Lode-King Recalls Trailers With Missing Rear Impact Guard Welds

    Lode-King is recalling 2019-2026 trailers because missing welds on the rear impact guard reduce structural strength, increasing injury risk in rear-end crashes.

    Product
    LODE KING — LODE KING SDG53-3, SDF53-3, SDF50-3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26V270000·2026-04-28

    Harley-Davidson motorcycles recalled for blocked breather port

    Harley-Davidson is recalling certain 2024–2026 motorcycles with a potentially blocked airbox breather port that may cause crankcase pressure to build up, risking oil ejection and injury when the dipstick is removed.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON FLTRXL, FXBR, FLFB, FLHLT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26V267000·2026-04-28

    Jayco Recalls 2026 Motorhomes Due to Missing Water Heater Valve

    Jayco is recalling 2026 Entegra Condor and Granite Ridge motorhomes because a tempering mixing valve may be missing from the water heater, creating a scalding risk.

    Product
    ENTEGRA — ENTEGRA, JAYCO CONDOR, GRANITE RIDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide