The Recall Desk

State

Puerto Rico product recalls

72,936 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 72,936 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

2926–2950 of 76026

  • SevereFDA (Devices)·Z-1455-2026·2026-03-04

    Olympus Inner Sheath Model A2641 Recalled Over Ceramic Tip Breakage

    Olympus is recalling all lots of its Inner Sheath, Model A2641, used in urological endoscopic procedures, due to complaints that the ceramic tip can break during use.

    Product
    Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0344-2026·2026-03-04

    Agebox iKids-Growth Day Formula Capsules Recalled Over Undeclared Drug Ingredient

    Agebox is recalling 665 bottles of iKids-Growth Day Formula capsules because they contain undeclared ibutamoren, a drug ingredient not approved for marketing in the U.S.

    Product
    Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 50065 59701 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1434-2026·2026-03-04

    Medline Nail Kit Sterile Saline Wound Wash Recall

    Medline is recalling 8,773 NAIL KIT (Model DYKM1528) units because the sterile saline wound wash may not have been manufactured to the required sterility assurance level for sterile products.

    Product
    Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1460-2026·2026-03-04

    Reverse Shoulder Prosthesis Implants Recalled Over Incorrect Labeling

    Encore Medical, LP is recalling 20 Reverse Shoulder Prosthesis implants due to incorrect labeling. The recall affects nationwide distribution across multiple US states.

    Product
    Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0350-2026·2026-03-04

    Fluorescein Sodium Ophthalmic Strips Recalled Over Sterility Concerns

    Wizcure Pharmaa is recalling all lots of Fluorescein Sodium Ophthalmic Strips because the products may not have been manufactured according to current good manufacturing practices, raising concerns about sterility assurance.

    Product
    C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS — C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS (FLUORESCEIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1446-2026·2026-03-04

    Olympus resection sheath recalled due to ceramic tip breakage

    Olympus is recalling 207 units of its Resection Sheath, Model A22043T, after receiving complaints that the ceramic tip can break during use. The recall affects all lots distributed nationwide.

    Product
    Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1467-2026·2026-03-04

    Medline Dialysis Kits Recalled Over Tego Connector Seal Defects

    Medline Industries is recalling dialysis dressing change kits containing Tego Connectors due to potential silicone seal doming or tearing that may block fluid flow during use.

    Product
    Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 EBSI1596 EBSI1781 EBSI1812 Centurion DIALYSIS/PHERESUS CVC DRSG CHANGE KIT SKU DT22630 Medline DIALYSIS/PHERESIS DRESSING
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1459-2026·2026-03-04

    Knee and Humeral Socket Implants Recalled for Incorrect Labeling

    Encore Medical, LP is recalling 14 EMPOWR 3D KNEE implants because they contain incorrect labeling. The recall affects US nationwide distribution.

    Product
    Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1453-2026·2026-03-04

    Olympus Inner Sheath 21 Fr. Model A2660T Medical Device Recall

    Olympus is recalling all lots of its Inner Sheath 21 Fr. Model A2660T used in urological procedures due to reports of the ceramic tip breaking during use.

    Product
    Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1474-2026·2026-03-04

    Remel Campy CVA Medium Lot Recalled Over Low Pathogen Recovery

    Remel, Inc is recalling 97 units of Campy CVA Medium 100/PK, lot R01272, due to customer complaints reporting low to no recovery of Campylobacter Jejuni ATCC 33291. The product was distributed nationwide in AZ, CO, IL, NJ, OH, TN, and WA.

    Product
    Campy CVA Medium 100/PK, R01272
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1458-2026·2026-03-04

    Shoulder prosthesis humeral socket inserts recalled over incorrect implant labeling

    Encore Medical is recalling Reverse Shoulder Prosthesis humeral socket inserts, catalogue number 509-00-432, because knee and humeral socket implants contain incorrect labeling.

    Product
    Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1463-2026·2026-03-04

    Medline Kits with Tego Connectors Recalled Due to Silicone Seal Defects

    Medline Industries, LP is recalling specific Medline Kits containing Tego Connectors because the silicone seals may dome or tear, potentially causing fluid leakage or blocked paths.

    Product
    Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1440-2026·2026-03-04

    Olympus resection inner sheath recalled after ceramic tip breakage complaints

    Olympus is recalling its Resection Inner Sheath for 26 Fr outer sheath, model A22040T, used in urologic applications, after complaints that the ceramic tip of the resection sheath can break.

    Product
    Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0352-2026·2026-03-04

    BioGlo fluorescein ophthalmic strips recalled over sterility assurance failure

    Wizcure Pharmaa is recalling all lots of BioGlo Fluorescein Sodium Ophthalmic Strips in 100-strip packs because the products were not manufactured in conformance with current good manufacturing practices.

    Product
    BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:[email protected], Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0349-2026·2026-03-04

    Vista Gonio Eye Lubricant Recalled Due to Sterility Concerns

    Vista Gonio Eye Lubricant eye drops are being recalled because they may not be sterile. The product was not manufactured according to proper sterile drug-making standards.

    Product
    VISTA GONIO EYE LUBRICANT — VISTA GONIO EYE LUBRICANT (HYPROMELLOSE OPHTHALMIC SOLUTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1468-2026·2026-03-04

    Medline dialysis dressing change kits recalled over connector seal defects

    Medline is recalling convenience kits containing Tego Connectors, sold as the Medline Dialysis Dressing Change kit, because the silicone seal may dome or tear and occlude the fluid path.

    Product
    Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1441-2026·2026-03-04

    Olympus resection sheath recalled due to ceramic tip breakage

    Olympus is recalling 3,484 Resection Sheaths, Model A22041A, after receiving complaints that the ceramic tip can break during urologic procedures. The recall covers all lots distributed nationwide.

    Product
    Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0518-2026·2026-03-04

    Gerber arrowroot biscuits recalled over possible paper and plastic fragments

    Gerber is recalling Arrowroot Biscuits in a downstream recall because they contain an arrowroot flour ingredient recalled by the supplier over potential contamination with soft kraft paper and plastic bag pieces.

    Product
    Gerber Arrowroot Biscuits, Net Wt. 5.5 oz. (155g), packaged in a plastic resealable bag with UPC 015000005962, packed 4 bags/case with UPC 015000935726; Made for Gerber Products Co., Fremont, MI 49413
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1443-2026·2026-03-04

    Olympus Resection Sheath Recalled Due to Ceramic Tip Breaking

    Olympus is recalling 1,676 resection sheaths after complaints of ceramic tips breaking during urologic procedures.

    Product
    Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1444-2026·2026-03-04

    Olympus 26 French resection sheath recalled over ceramic tip breakage

    Olympus is recalling its Resection Sheath, 26 Fr, with Deflecting Obturator, model A22042T, used in urologic applications, after complaints that the ceramic tip can break.

    Product
    Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1464-2026·2026-03-04

    Medline dialysis kits recalled over damaged Tego connector silicone seals

    Medline is recalling certain Dialysis On/Off Kits containing Tego Connectors because the silicone seal may dome or tear, which can occlude the fluid path or allow leakage.

    Product
    Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1454-2026·2026-03-04

    Olympus 10 French sheath recalled over ceramic tip breakage complaints

    Olympus is recalling its Sheath, 10 Fr, model A37004A, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip can break.

    Product
    Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1465-2026·2026-03-04

    Medline dialysis maintenance kits recalled over Tego connector seal defects

    Medline is recalling seven convenience kits used for dialysis maintenance because the silicone seal on the Tego Connectors may dome or tear, which can occlude the fluid path.

    Product
    Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 Medline DIALYSI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1437-2026·2026-03-04

    Olympus Cystoscope Outer Sheath Recalled Due to Potential Device Tip Damage

    Olympus Corporation of the Americas is recalling Olympus Cystoscope Outer Sheath (Model WA22810A) because it may be incompatible with GreenLight Laser therapy, potentially damaging the device tip.

    Product
    Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
    Category
    Medical Device
    Distribution
    Distributed nationwide