The Recall Desk

State

Puerto Rico product recalls

72,940 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 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3626–3650 of 76030

  • ModerateFDA (Drugs)·D-0280-2026·2026-01-21

    PALACOS MV plus G bone cement recalled because ampoules may not break

    Heraeus Medical is recalling PALACOS MV+G pro 40 and PALACOS MV+G pro 80 bone cement because an unfortunate combination of factors can leave ampoules unbroken, so no appropriate cement dough is formed.

    Product
    Swan, White Clear Alcohol, 50%, 16oz, 12 count
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0259-2026·2026-01-21

    Carotid anesthesia kits recalled over recalled B. Braun administration sets inside

    Medline is recalling 10 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1091-2026·2026-01-21

    Azurion systems recalled over six identified software issues

    Philips Medical Systems Nederland is recalling 10,466 Azurion systems on software versions R2.1.10 and R2.2.10 over six identified software issues including continuous restart.

    Product
    Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Num
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1074-2026·2026-01-21

    Allura Xper FD10/10 systems recalled over a missing cooling unit drip tray

    Philips Medical Systems Nederland is recalling 22 units of the Allura Xper FD10/10, model 722027, because the drip tray beneath the cooling unit may not have been installed.

    Product
    Allura Xper FD10/10; Model Number: 722027;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1086-2026·2026-01-21

    Laparoscopy kits recalled over suction irrigators that can leak during use

    Medline is recalling 41,432 laparoscopy convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.

    Product
    Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOPIC, REF CDS930223M; 3) LAP CHOLE CDS, REF CDS983678K; 4) LAPAROSCOPY PELV CDS, REF CDS983679K; 5) LAP CHOLE CDS-LF, REF CDS983752M; 6) LAP CHOLE CDS-LF,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1087-2026·2026-01-21

    PALACOS MV bone cement recalled because ampoules may not break

    Heraeus Medical is recalling PALACOS MV pro 40 and PALACOS MV pro 80 bone cement because an unfortunate combination of factors can leave ampoules unbroken, so no appropriate cement dough is formed.

    Product
    Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF; 2) ROBOTIC PROCEDURE, REF CDS982128Q; 3) CUH THORACIC, REF CDS984338M; 4) THORACIC PROCEDURE, REF CDS984640I; 5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O; 6) LAP CHO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1051-2026·2026-01-21

    Pre-op kits recalled because they contain recalled B. Braun administration sets

    Medline is recalling 32 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KIT, Medline SKU DYKS2034A; 2) DELUXE PRE OP KIT, Medline SKU DYKS2006B.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1050-2026·2026-01-21

    Open heart kits recalled because they contain recalled B. Braun administration sets

    Medline is recalling 633 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O; 2) OPEN HEART CDSKit SKU CDS984355K; 3) BAG A OPEN HEART KITKit SKU DYKM1025D; 4) RR-CABG SUPPLEMENTAL PACKKit SKU DYNJ0394752
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1066-2026·2026-01-21

    Allura Xper FD20, model 722006, recalled over a missing drip tray

    Philips Medical Systems Nederland is recalling 143 units of the Allura Xper FD20, model 722006, because the drip tray beneath the cooling unit may not have been installed.

    Product
    Allura Xper FD20; Model Number: 722006;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1076-2026·2026-01-21

    Preoperative kits recalled over recalled B. Braun administration sets inside

    Medline is recalling 11173 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.

    Product
    Allura Xper FD20/10; Model Number: 722029;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1049-2026·2026-01-21

    Allura Xper FD20/10 systems recalled over a missing cooling unit drip tray

    Philips Medical Systems Nederland is recalling 4 units of the Allura Xper FD20/10, model 722029, because the drip tray beneath the cooling unit may not have been installed.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH KIT-LF, Medline Kit SKU PHS972096014B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1072-2026·2026-01-21

    Allura Xper FD20 OR Table recalled over a missing cooling unit drip tray

    Philips Medical Systems Nederland is recalling 4 units of the Allura Xper FD20 OR Table, model 722023, because the drip tray beneath the cooling unit may not have been installed.

    Product
    Allura Xper FD20 OR Table; Model Number: 722023;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1069-2026·2026-01-21

    Allura Xper FD10/10, model 722011, recalled over a missing drip tray

    Philips Medical Systems Nederland is recalling 21 units of the Allura Xper FD10/10, model 722011, because the drip tray beneath the cooling unit may not have been installed.

    Product
    Allura Xper FD10/10; Model Number: 722011;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1085-2026·2026-01-21

    Robotic thoracic and cardiac kits recalled over leaking suction irrigators

    Medline is recalling 96 units of procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.

    Product
    Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1089-2026·2026-01-21

    Hysterectomy procedure kits recalled over leaking suction irrigators inside

    Medline is recalling 1457 units of procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.

    Product
    Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F; 4) LAVH, REF DYNJQ9041R; 5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I; 6) ROBOTIC LAVH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1055-2026·2026-01-21

    IV supply drawers recalled over recalled B. Braun administration sets inside

    Medline is recalling 3045 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC010271B; 2) DRAWER 2 IV FLUIDS & TUBING, Medline kit SKU ACC010416B; 3) OXYGENATION & TUBING TRAY, Medline kit SKU ACC010525C; 4)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1054-2026·2026-01-21

    Facial procedure packs recalled over recalled B. Braun administration sets inside

    Medline is recalling 16 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit SKU DYNJ54488A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1075-2026·2026-01-21

    Allura Xper FD20, model 722028, recalled over a missing drip tray

    Philips Medical Systems Nederland is recalling 2 Allura Xper FD20 systems because the drip tray beneath the cooling unit may not have been installed.

    Product
    Allura Xper FD20; Model Number: 722028;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1038-2026·2026-01-21

    Universal implant inserters recalled because the rotation tool handle can untread

    Medicrea International is recalling 44 IB3D Universal Implant Inserters because, following complaints, the orthopedic rotation tool handle may untread from the shaft.

    Product
    Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1039-2026·2026-01-21

    Spinal instrument sets recalled because the rotation tool handle can untread

    Medicrea International is recalling 44 IB3D PL Instruments Sets because, following complaints, the orthopedic rotation tool handle may untread from the shaft.

    Product
    Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1070-2026·2026-01-21

    Surgical procedure packs recalled over recalled B. Braun administration sets inside

    Medline is recalling 338 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.

    Product
    Allura Xper FD20; Model Number: 722012;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1068-2026·2026-01-21

    Allura Xper FD10, model 722026, recalled over a missing cooling unit drip tray

    Philips Medical Systems Nederland is recalling 95 units of the Allura Xper FD10, model 722026, because the drip tray beneath the cooling unit may not have been installed.

    Product
    Allura Xper FD10; Model Number: 722010;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1017-2026·2026-01-21

    Allura Xper FD20 systems recalled over a missing cooling unit drip tray

    Philips Medical Systems Nederland is recalling 79 units of the Allura Xper FD20, model 722012, because the drip tray beneath the cooling unit may not have been installed.

    Product
    VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1041-2026·2026-01-21

    CT pendant upgrades recalled for missing a safe hand position label

    Mobius Imaging is recalling 26 detachable 10in pendant upgrade components for the AIRO CT X-ray System because they do not carry the Safe Hand Position Warning label.

    Product
    Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1040-2026·2026-01-21

    CT pendant replacement kits recalled for missing a safe hand position label

    Mobius Imaging is recalling 101 detachable 10in pendant replacement components for the AIRO CT X-ray System because they do not carry the Safe Hand Position Warning label.

    Product
    Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide