The Recall Desk

State

Puerto Rico product recalls

72,820 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 72,820 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

601–625 of 75910

  • SevereFDA (Devices)·Z-2683-2026·2026-07-22

    ABIOMED Impella CP Introducer Kit 14Fr heart pump safety recall

    ABIOMED Impella CP Introducer Kit 14Fr is being recalled due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable by users.

    Product
    ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0689-2026·2026-07-22

    Cleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns

    Chiesi USA, Inc. is recalling Cleviprex (clevidipine) injectable emulsion due to lack of assurance of sterility. The affected product is distributed nationwide.

    Product
    CLEVIPREX — CLEVIPREX (CLEVIPIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2704-2026·2026-07-22

    Transvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled

    Argon Medical Devices is recalling Transvenous Pacing Electrode Trays with Bipolar Balloon Pacing Electrode 5F because kits containing Lidocaine HCL Injection USP did not meet sterility release criteria.

    Product
    Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2707-2026·2026-07-22

    T-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure

    Argon Medical Devices is recalling T-Lok Bone Marrow Tray kits containing Lidocaine HCL Injection USP 1% because the kits did not meet sterility release criteria.

    Product
    T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2685-2026·2026-07-22

    Abiomed Impella CP Introducer Kit heart pump accessory recall

    Abiomed is recalling Impella CP Introducer Kits worldwide due to potential leakage from the introducer sheath that cannot be visually detected by users. The manufacturing defect affects 1,540 units across multiple countries.

    Product
    ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0690-2026·2026-07-22

    ChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects

    CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) applicators nationwide because affected units may have open or incomplete seals on the packaging, which could compromise sterility assurance.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2692-2026·2026-07-22

    ABIOMED Insertion Kit heart pump accessories introducer sheath leakage

    Abiomed is recalling ABIOMED Insertion Kits due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable by users.

    Product
    ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2681-2026·2026-07-22

    ABIOMED Impella RP Flex heart pump introducer sheath leakage risk

    Abiomed is recalling the Impella RP Flex heart pump due to potential introducer sheath leakage from the sheath cap and hub score lines. The manufacturing defect is not visually detectable.

    Product
    ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2688-2026·2026-07-22

    Abiomed Impella 5.5 SmartAssist S2 heart pump introducer sheath leakage risk

    Abiomed is recalling Impella 5.5 SmartAssist S2 heart pump sets worldwide due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines that may not be visible to users.

    Product
    ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2689-2026·2026-07-22

    ABIOMED Impella CP Heart Pump Set Introducer Sheath Leakage Risk

    ABIOMED is recalling Impella CP heart pump sets worldwide due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines in 14Fr and 23Fr introducers. The manufacturing defect is not visually detectable.

    Product
    ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2682-2026·2026-07-22

    ABIOMED Impella CP Heart Pump Introducer Sheath Leakage Risk

    Abiomed is recalling the Impella CP heart pump set (87,277 units worldwide) due to potential leakage from the introducer sheath that cannot be visually detected by users. The defect affects the 14Fr and 23Fr introducers included in every pump set.

    Product
    ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2724-2026·2026-07-22

    ICU Medical Plum Solo Precision IV Pump May Deliver Excess Medication

    ICU Medical is recalling the Plum Solo Precision IV Pump (v1.0.3) because in specific scenarios, the pump may fail to decrease the displayed volume and could deliver up to twice the programmed medication amount.

    Product
    ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2705-2026·2026-07-22

    One-Piece Introducer Tray kits recalled for sterility failure

    Argon Medical Devices is recalling One-Piece Introducer Tray kits containing Lidocaine HCL Injection because they do not meet sterility release criteria. The kits were distributed nationwide and internationally.

    Product
    One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2718-2026·2026-07-22

    Olympus Toomey Evacuator 30cc medical device sterilization parameters recalled

    Olympus Corporation recalled the Toomey Evacuator 30cc with Adaptor (Model 188) because certain sterilization parameters in the instructions may not consistently render the devices adequately sterile.

    Product
    Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V475000·2026-07-22

    Freightliner Trucks Recalled for Low Beam Headlight Software Error

    Daimler Trucks North America is recalling 2026-2027 Freightliner models because a software error may cause low beam headlights to illuminate improperly, increasing crash risk.

    Product
    FCCC — FCCC, FREIGHTLINER S2C, S2RV, BUSINESS CLASS M2, EM2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2725-2026·2026-07-22

    Rapid Refill Continuous Injection System Recalled for Syringe Loosening Risk

    Boston Scientific's Rapid Refill Continuous Injection System (UPN M00566001) is being recalled because the recalled Medline Namic Angiographic Control Syringe may loosen or disconnect from the manifold, potentially causing leakage, inability to aspirate or inject, and procedure delays.

    Product
    Rapid Refill Continuous Injection System, UPN M00566001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2719-2026·2026-07-22

    Olympus Toomey Evacuator 50cc with Adaptor sterilization recall

    Olympus is recalling the Toomey Evacuator 50cc with Adaptor (Model 188A) because some sterilization parameters in the instructions may not reliably render the devices sterile.

    Product
    Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2741-2026·2026-07-22

    Vasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall

    Maquet Cardiovascular is recalling Vasoview Hemopro 2 devices from Lot 3000547797 due to exposure to out-of-specification sterilization during gamma sterilization. The affected devices may not be properly sterilized.

    Product
    The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K101274.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V471000·2026-07-22

    ATC Recalls 2026 RM500 and RM700 Trailers Due to Winch Remote Issue

    Aluminum Trailer Company is recalling 2026 RM500 and RM700 trailers because the wireless remote may cause unexpected winch movements, increasing injury risk.

    Product
    ATC — ATC RM500, RM700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26V473000·2026-07-22

    2024–2026 Volkswagen Atlas and Atlas Cross Sport Rearview Camera Software

    Volkswagen is recalling 2024–2026 Atlas and Atlas Cross Sport vehicles due to a low-voltage electrical event that may cause the rearview camera display to fail, reducing rear visibility.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS, ATLAS CROSS SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2727-2026·2026-07-22

    GE Optima XR200/220/240amx Radiographic System Column Safety Mechanism

    GE Medical Systems is recalling certain Optima XR200/220/240amx mobile radiographic systems after column replacements because functional testing of the safety pawl may not have been performed, which could allow the X-ray arm to drop and injure patients.

    Product
    Optima XR220amx, Mobile Digital-Ready Radiographic System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2721-2026·2026-07-22

    Olympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall

    Olympus Corporation is recalling the Glass Body for 194 Ellik Evacuator (Model 190A) because certain sterilization parameters in the instructions may not consistently render the devices adequately sterile.

    Product
    Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2726-2026·2026-07-22

    GE Medical Optima XR200/220/240amx Mobile Radiographic Systems Recall

    GE HealthCare recalls certain Optima XR200/220/240amx mobile radiographic systems where safety testing may have been incomplete after column replacement. A failed counterpoise cable could cause the X-ray arm to drop on patients.

    Product
    Optima XR200amx, Mobile Digital-Ready Radiographic System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26E047000·2026-07-22

    Hiab Recalls K-HiPro Cranes Due to Potential Column Weld Failure

    Hiab USA Inc. is recalling K-HiPro 425 and 505 cranes because a weld may crack, risking column collapse and injury.

    Product
    EQUIPMENT:MECHANICAL:BOOM/CRANE/LADDER recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide