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.

3801–3825 of 76030

  • HighFDA (Devices)·Z-0941-2026·2025-12-24

    Imaging viewer software recalled over inaccurate length measurement values

    DICOM Grid is recalling 924 units of Intelerad InteleShare software because a bug can produce inaccurate length measurement tool values that could lead to misdiagnosis.

    Product
    Intelerad InteleShare software, with ProViewer component
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0921-2026·2025-12-24

    Sterile operating room scissors recalled over weak seals affecting sterility

    Medline is recalling 56 sterile operating room scissors because weak packaging seals may result in a breach of sterility and an increased risk of infection if the product is used.

    Product
    SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25C011000·2025-12-24

    Evenflo Recalls All4One Child Seats Due to Recline Mechanism Defect

    Evenflo is recalling certain All4One child seats because the recline mechanism may shift out of position, potentially failing to secure a child in a crash.

    Product
    CHILD SEAT:BASE:RECLINE MECHANISM recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0922-2026·2025-12-24

    Sterile Kelly forceps recalled over weak seals that may breach sterility

    Medline is recalling 53 sterile Kelly forceps because weak packaging seals may result in a breach of sterility and an increased risk of infection if the product is used.

    Product
    FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0228-2026·2025-12-24

    Xylocaine dental cartridges recalled over cracked and broken containers

    Novocol Pharmaceutical of Canada is recalling 18,789 cartons of 2% Xylocaine Dental with Epinephrine over a defective container with cracked or broken cartridges.

    Product
    2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0234-2026·2025-12-24

    Phentolamine mesylate injection recalled over cracked and broken cartridges

    Novocol Pharmaceutical of Canada is recalling 1,636 cartons of OraVerse (Phentolamine Mesylate) Injection over a defective container with cracked or broken cartridges.

    Product
    ORAVERSE — ORAVERSE (PHENTOLAMINE MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0957-2026·2025-12-24

    Bone fixation screws recalled over a labeling error on one lot

    Smith & Nephew is recalling 168 BIOSURE HA Screws, 6mm x 20mm, due to a labeling error on the affected lot.

    Product
    BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0236-2026·2025-12-24

    Cisatracurium 10 mg vials recalled after subpotent stability assay results

    Somerset Therapeutics is recalling 52,340 vials of Cisatracurium Besylate Injection, 10 mg/5 mL, after out of specification assay results during long term stability testing.

    Product
    CISATRACURIUM BESYLATE — CISATRACURIUM BESYLATE (CISATRACURIUM BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0956-2026·2025-12-24

    Children's mouthguards recalled for distribution without FDA premarket clearance

    Myofunctional Research Company USA is recalling 436 Myosa for Kids devices because the firm mistakenly distributed the product within the US without FDA premarket clearance or approval.

    Product
    Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and myofunctional disorders. Catalog Numbers:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0238-2026·2025-12-24

    Cisatracurium 20 mg multiple-dose vials recalled after subpotent assay results

    Somerset Therapeutics is recalling 71,310 vials of Cisatracurium Besylate Injection, 20 mg/10 mL, after out of specification assay results during long term stability testing.

    Product
    CISATRACURIUM BESYLATE — CISATRACURIUM BESYLATE (CISATRACURIUM BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0948-2026·2025-12-24

    Pectoral implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 41 AART Pectoral Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-DI code: B4905001065 500-106-6 Pectoral Implant style 1 size 6 right UDI-DI code: B4905001066 500-200-5 Pectoral Implant style 2 si
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0949-2026·2025-12-24

    Calf implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 35 AART Calf Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 502-104 - Calf Implant style 1 size 4 UDI-DI code: B490502104 502-105 - Calf Implant style 1 size 5 UDI-DI code: B490502105
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0947-2026·2025-12-24

    Malar facial implants recalled over specification deviations and missing clearance

    DSAART is recalling 2 AART Malar Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI-DI code: B4904012026
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0944-2026·2025-12-24

    Silicone carving implants recalled over specification deviations and missing clearance

    DSAART is recalling 369 AART Silicone Carving Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 600-602 - Silicone Carving Implant Style 6 Size 2 UDI-DI code: B490600602 600-601-9 - Silicone Carvi
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Drugs)·D-0240-2026·2025-12-24

    Ciclopirox shampoo recalled after failing impurity specifications at eighteen months

    Sun Pharma/Taro is recalling 17,664 units of Ciclopirox Shampoo 1% after out of specification impurity and degradation results at the 18-month timepoint.

    Product
    Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0945-2026·2025-12-24

    Gluteal implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 118 AART Gluteal Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1 size 1 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3 UDI-DI code: B490501103 501-101 UDI-DI code: B490501101 501-103 - Gluteal
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Drugs)·D-0232-2026·2025-12-24

    Benco mepivacaine cartridges recalled over cracked and broken containers

    Novocol Pharmaceutical of Canada is recalling Mepivacaine HCl 3% injection distributed by Benco Dental over a defective container with cracked or broken cartridges.

    Product
    MEPIVACAINE — MEPIVACAINE (MEPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0237-2026·2025-12-24

    Cisatracurium 200 mg vials recalled after subpotent stability assay results

    Somerset Therapeutics is recalling 28,660 vials of Cisatracurium Besylate Injection, 200mg/20mL, after out of specification assay results during long term stability testing.

    Product
    CISATRACURIUM BESYLATE — CISATRACURIUM BESYLATE (CISATRACURIUM BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0229-2026·2025-12-24

    Lidocaine and epinephrine dental cartridges recalled over cracked containers

    Novocol Pharmaceutical of Canada is recalling 12,033 cartons of Lidocaine HCl 2% with Epinephrine 1:100,000 injection over a defective container with cracked or broken cartridges.

    Product
    LIDOCAINE — LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0946-2026·2025-12-24

    Chin implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 29 AART Chin Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B490400101 400-0103 Chin Implant style 1 size 3 UDI-DI code: B490400103 400-0104 Chin Implant style 1 size 4 UDI-DI code: B490400104 40
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Drugs)·D-0233-2026·2025-12-24

    Carbocaine dental cartridges recalled over cracked and broken containers

    Novocol Pharmaceutical of Canada is recalling 40 cartons of Cook-Waite Carbocaine 3% mepivacaine injection over a defective container with cracked or broken cartridges.

    Product
    CARBOCAINE — CARBOCAINE (MEPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0230-2026·2025-12-24

    Polocaine dental cartridges recalled over cracked and broken containers

    Novocol Pharmaceutical of Canada is recalling 5,825 units of 3% Polocaine Dental mepivacaine injection over a defective container with cracked or broken cartridges.

    Product
    POLOCAINE — POLOCAINE (MEPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide