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.

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.

901–925 of 75997

  • ModerateFDA (Devices)·Z-2544-2026·2026-07-08

    Medline Lumbar Puncture Kit recalled for Lidocaine quality issues

    Medline Convenience Kits containing Huons Lidocaine HCL Injection USP 1% ampules are being recalled due to quality issues identified during an FDA manufacturing inspection. Affected kits have been distributed nationwide.

    Product
    Medline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2630-2026·2026-07-08

    CRE Pro Wireguided Medical Device Recall for Sterile Packaging Breach

    Boston Scientific is recalling the CRE Pro Wireguided 15-18mm 240cm device due to a potential sterile breach of the product pouches. The breach may compromise device sterility.

    Product
    CRE Pro Wireguided 15-18mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2659-2026·2026-07-08

    PowerPICC SV Catheters recalled due to deficient lidocaine manufacturing

    Bard Access Systems is recalling PowerPICC SV Catheters because lidocaine ampoules supplied with the product were manufactured under deficient practices.

    Product
    1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen REKV2227 00801741027536 The PowerPlCC SV catheters are intended for short or long term peripheral access to the central venous system for intravenous th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2540-2026·2026-07-08

    Medline Suturing Set with Lidocaine Ampules Recalled

    Medline Convenience Kits (Suturing Set, Model SUT13710) containing Huons Lidocaine HCL Injection USP are being recalled due to quality issues identified during an FDA manufacturing inspection.

    Product
    Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2660-2026·2026-07-08

    Power-Trialysis Dialysis Catheters Recalled Due to Manufacturing Defects

    Bard Access Systems is recalling Power-Trialysis Short-Term Dialysis Catheters with triple-lumen design due to lidocaine ampoules manufactured under deficient manufacturing practices. The recall affects approximately 8,795 units distributed nationwide and internationally.

    Product
    5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 5605240 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086977 5605300 Power-Trialysis Short-Term Straight Dialysis C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2663-2026·2026-07-08

    PowerMidline Catheter 4 Fr Dual-Lumen due to deficient manufacturing

    Bard Access Systems is recalling PowerMidline Catheter 4 Fr Dual-Lumen catheters because lidocaine ampoules were manufactured under deficient manufacturing practices.

    Product
    CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129278 P4254108D PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129353 The PowerMidline" Catheter is intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2655-2026·2026-07-08

    Thoracentesis and Paracentesis Trays Recalled for Deficient Manufacturing

    Bard Access Systems, Inc. is recalling three models of thoracentesis and paracentesis trays due to lidocaine ampoules being manufactured under deficient manufacturing practices. The devices are used for fluid removal procedures and have been distributed nationwide and in Belgium.

    Product
    OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 The Acute Drainage devices are indicated for use in re
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2537-2026·2026-07-08

    Medline Convenience Kits with Lidocaine Ampules Recalled for Quality Issues

    Medline Industries is recalling three convenience kits containing Huons Lidocaine HCL Injection USP 1% due to quality issues identified during an FDA manufacturing inspection of Huons' facility.

    Product
    Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2) PAIN1470A, Model Number: CONT. 20G EPI MRI COMPATIBLE; 3) TVS4000L, Model Number: TVS4000 ENDOVENOUS PACK
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2669-2026·2026-07-08

    Solar GI System Water Perfusion Units Recalled Due to Moisture Accumulation

    Laborie Medical Technologies is recalling Solar GI System (Water Perfusion) units worldwide because moisture may accumulate in internal tubing and filters under extended use, potentially affecting airflow and pressure measurement performance.

    Product
    Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley system (G3-8), Solar GI HRM H2O, 36p, Trolley system (G3-12), Solar GI HRAM H2O, 24p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2668-2026·2026-07-08

    Soft Tissue Biopsy Trays recalled due to deficient manufacturing practices

    Bard Access Systems is recalling soft tissue biopsy trays (models 4380 Economy and 4382A) due to lidocaine ampoules being manufactured under deficient manufacturing practices.

    Product
    4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108501 The Soft Tissue Biopsy devices are indicated for use in the collection of aspirate tissue (e.g. liver, kidney, etc.).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0693-2026·2026-07-08

    Tridergel Benzalkonium Chloride Wound Care Gel Recalled

    Blaine Labs Inc is recalling Tridergel wound care gel nationwide due to current good manufacturing practice (CGMP) deviations. The product was manufactured in a facility under the same conditions as contaminated product.

    Product
    TRIDERGEL — TRIDERGEL (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0698-2026·2026-07-08

    Fungal Fusion antifungal kit recalled for discontinued stability testing

    Blaine Labs Inc is recalling Fungal Fusion ERADICATION Solution kits nationwide because the manufacturer discontinued required stability testing for products still on the market within their expiration dates.

    Product
    Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1oz bottle of Fungal Fusion Eradication Antimicrobial Show
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2657-2026·2026-07-08

    DuoGlide Short-Term Dialysis Catheter recall due to deficient manufacturing

    Bard Access Systems is recalling lidocaine ampoules used with DuoGlide Short-Term Dialysis Catheters due to deficient manufacturing practices by the supplier. The catheters are used for temporary vascular access for hemodialysis.

    Product
    5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 The intended use of the Short-Term Dialysis Catheter is attaining temporary/short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, or apheresis thera
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0696-2026·2026-07-08

    vite20 Antifungal Cream recalled due to stability testing deviations

    Blaine Labs Inc is recalling vite20 Antifungal Cream (10% Undecylenic Acid) because the manufacturer discontinued required stability testing for products still on the market within expiration dates.

    Product
    vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, UPC 6 16728 00039 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2547-2026·2026-07-08

    Medline Ophthalmic Pack with Lidocaine Injection Kits Recalled

    Medline is recalling Ophthalmic Pack convenience kits containing Huons Lidocaine HCL Injection due to quality issues identified during an FDA manufacturing inspection. The recall affects 180 kits distributed nationwide.

    Product
    Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0714-2026·2026-07-08

    Gemcitabine Injection Recalled Due to Temperature Storage Abuse

    McKesson is recalling Gemcitabine Injection (1 g per 26.3 mL) due to temperature abuse—the product was stored at controlled room temperature instead of under refrigeration. The affected lot was distributed nationwide.

    Product
    GEMCITABINE — GEMCITABINE (GEMCITABINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2656-2026·2026-07-08

    Poly Midline Catheters recalled due to manufacturing defects

    Bard Access Systems is recalling Poly Midline Catheters because lidocaine ampoules were manufactured under deficient manufacturing practices.

    Product
    CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 The Poly Per-Q-Cath Midline cathet
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2542-2026·2026-07-08

    Medline Convenience Kits recalled for defective Lidocaine Ampules

    Medline Industries is recalling 15,662 Convenience Kits containing Huons Lidocaine HCL Injection USP due to quality issues identified during an FDA manufacturing inspection of the drug supplier's facility.

    Product
    Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 3) CONTRACEPTIVE IMPLANT INSERTION KIT, Model Number: MNS9715; 4) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 5) MYELOGRAM PACK, Model Number: P15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0697-2026·2026-07-08

    Terpenicol Antifungal Solution Recalled for CGMP Deviations

    Blaine Labs Inc is recalling Terpenicol (Undecylenic Acid) antifungal solution because the firm discontinued required stability testing for products still on the market within their expiration dates.

    Product
    TERPENICOL — TERPENICOL (UNDECYLENIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2661-2026·2026-07-08

    Power-Trialysis Slim-Cath Dialysis Catheters Recalled by Bard Access Systems

    Bard Access Systems is recalling Power-Trialysis Slim-Cath short-term dialysis catheters due to lidocaine ampoules manufactured under deficient manufacturing practices. The recall affects multiple product models distributed nationwide and internationally.

    Product
    5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 5855300 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107184 5865120 Power-Trialysis Slim-Cath
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2546-2026·2026-07-08

    Medline Circumcision Trays recalled due to Lidocaine quality issues

    Medline Industries is recalling three models of circumcision trays containing Lidocaine ampules due to quality issues identified during an FDA inspection of the drug manufacturer.

    Product
    Medline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT6780; 2) CIRCUMCISION TRAY W/1.1CM CIRCLAMP, Model Number: CIT3225A; 3) CIRCUMCISION TRAY, Model Number: CIT6325
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2674-2026·2026-07-08

    Sterile Tourniquet Hoses recalled for potential sterility breach

    Zimmer Surgical Inc is recalling A.T.S 4000 TS Tourniquet Systems Single Hose units due to a potential sterility breach in the sealing area of the sterile pouch. If used, the compromised sterility may result in moderate localized infection.

    Product
    Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single Sterile Extension Hose with PLC Connector Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2666-2026·2026-07-08

    PowerPICC Catheters recalled for deficient manufacturing practices

    Bard Access Systems, Inc. is recalling multiple PowerPICC catheter models due to lidocaine ampoules being manufactured under deficient manufacturing practices by the supplier.

    Product
    1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC SOLO Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034602 1174108D3 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1174108D4 PowerPICC Catheter 4 Fr Single-Lum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2662-2026·2026-07-08

    PowerMidline Catheters Recalled for Deficient Manufacturing Practices

    Bard Access Systems is recalling PowerMidline Catheters due to lidocaine ampoules being manufactured under deficient manufacturing practices. The catheters are used for short-term peripheral intravenous access and have been distributed nationwide and internationally.

    Product
    CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138713 P4153108D PowerMidline Catheter 3 Fr Single-lumen UDI-DI Code: 00801741108747 P4154108 PowerMidline Catheter 4 Fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2653-2026·2026-07-08

    Covidien Shiley Disposable Decannulation Plug product labeling error

    Covidien LLC is recalling Shiley Disposable Decannulation Plug devices because the product labeling incorrectly indicates the product does not contain DEHP, when in fact the product contains 30 to 35% DEHP.

    Product
    Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Number / UDI-DI code 4DCFN 10884522006576 4DCFS 10884522006583 4DFEN 10884522006606 6DCFN 10884
    Category
    Medical Device
    Distribution
    Distributed nationwide