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.

Which agencies issued them

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.

1026–1050 of 75997

  • HighFDA (Devices)·Z-2566-2026·2026-07-01

    Surgify Halo Spinal Surgery Burrs Recalled for Breakage Risk

    Surgify Medical is recalling Surgify Halo 5.4 mm Short burrs (Model 54.070.NVG.H1) due to potential breakage during bi-portal endoscopic spinal surgery. The hazard could affect patient safety during the procedure.

    Product
    Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2580-2026·2026-07-01

    Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump recall

    Boston Scientific Corporation is recalling the Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump (model AP-0300H) due to potential leakage along the drug pathway from the pump through the catheter.

    Product
    Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2561-2026·2026-07-01

    Surgify Halo 4.0 mm Spinal Surgery Burrs May Break During Use

    Surgify Halo 4.0 mm Short burrs may break during bi-portal endoscopic spinal surgery, creating a potential hazard during the procedure. The FDA has classified this as a Class II recall affecting devices nationwide.

    Product
    Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2562-2026·2026-07-01

    Surgify Halo surgical drill may break during spinal surgery procedures

    Surgify Halo 4.0 mm surgical drills are being recalled because the burr may break during bi-portal endoscopic spinal surgery. The defect could interfere with the surgical procedure.

    Product
    Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2557-2026·2026-07-01

    Surgify Halo surgical drill recalled for potential burr breakage

    Surgify Halo 3.0 mm surgical drills may experience burr breakage during bi-portal endoscopic spinal surgery. The FDA is requesting the recall of this device across multiple US states.

    Product
    Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2563-2026·2026-07-01

    Surgify Halo surgical burr recalled for potential breakage during spinal surgery

    Surgify Halo 40 mm surgical burrs are being recalled because they may break during bi-portal endoscopic spinal surgery, potentially creating risks during the procedure.

    Product
    Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2026·2026-07-01

    Zimmer Shoulder Reamer Guide System Recalled for Plastic Breakage

    Zimmer is recalling Off-Axis Comprehensive Shoulder System reamer guides (Model 110040241) because plastic guides can catch and break during reaming. Five complaints have been received.

    Product
    Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2586-2026·2026-07-01

    Medline Industries Polycarbonate Syringes Convenience Kits Design Change Recall

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. Affected kits were distributed nationwide and internationally.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAPHY PACK-LF DYNJ0854485S DEEP BRAIN STIMULATION PACK DYNJ0842793G NEURO ACCESSORY PACK DYNJ55385A NEURO ANGIO PACK DYNJ51697B DYNJ56509G DYNJ56509I DYNJ680
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2532-2026·2026-07-01

    Acumed Hexalob Screws Recalled for Risk of Fracture During Use

    Acumed LLC is recalling Hexalob Screws of various sizes used with wrist fixation systems due to a manufacturing error that may cause the screws to break during use.

    Product
    Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm NL Hexalobe Screw; 3070-27010 2.7mm x 10mm NL Hexalobe Screw; 3070-27011 2.7mm x 11mm NL Hexalobe Screw; 3070-27012 2.7mm x 12mm NL Hexalobe Screw; 3070-27013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2571-2026·2026-07-01

    Surgify Halo surgical burrs recalled for potential breakage during spinal surgery

    Surgify Medical OY is recalling Surgify Halo 5.4 mm Long surgical burrs due to potential breakage during bi-portal endoscopic spinal surgery. The defect could affect patient safety during the procedure.

    Product
    Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0622-2026·2026-07-01

    ChloraPrep One-Step antiseptic solution sterility assurance recall

    CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) due to wrinkles in the paper lidding that may breach the seal area, compromising sterility assurance.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1124-2026·2026-07-01

    Pearl Milling Company Pancake and Waffle Mix Recalled for Undeclared Milk and Soy

    Pearl Milling Company Original Pancake & Waffle Mix Complete (5.99 oz) is being recalled because it contains undeclared milk and soy allergens. The product was distributed only in Puerto Rico.

    Product
    Pearl Milling Company Original Pancake & Waffle Mix Complete (Mezcla Para Panqueques y Waffles) Net Wt 5.99 oz (170 g). Packed in 50 - 5.99 oz BOPP Pouch units per master case. Keep in a cool, dry place.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2572-2026·2026-07-01

    Surgify Halo Surgical Burr Recalled for Breakage Risk

    Surgify Halo 5.4 mm surgical burrs may break during bi-portal endoscopic spinal surgery. The FDA is recalling this device nationwide due to the potential breakage hazard.

    Product
    Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0626-2026·2026-07-01

    Lacosamide 100mg Tablets Recalled Due to Foreign Tablet Contamination

    Annora Pharma is recalling Lacosamide 100mg tablets nationwide after discovering Selexipag 1000 mcg tablets mixed into bottles. Patients taking the wrong medication could experience unintended health effects.

    Product
    LACOSAMIDE — LACOSAMIDE (LACOSAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2568-2026·2026-07-01

    Surgify Halo Surgical Burr Breakage Risk During Spinal Surgery

    Surgify Medical is recalling Surgify Halo 5.4 mm Medium surgical burrs due to potential burr breakage during bi-portal endoscopic spinal surgery. The device poses a risk of fragmentation that could complicate surgical procedures.

    Product
    Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2552-2026·2026-07-01

    Stryker Neurovascular INZONE Detachment System battery drain

    Stryker Neurovascular is recalling the INZONE Detachment System (REF: M00345100950) due to premature battery drain that may prevent the device from powering on or detaching coils as intended.

    Product
    INZONE DETACHMENT SYSTEM, REF: M00345100950
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2588-2026·2026-07-01

    Medline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance requirements.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. MAJOR BASIN SET DYNJ85723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0617-2026·2026-07-01

    Duloxetine 30 mg capsules recalled for impurity above FDA limits

    Direct Rx is recalling Duloxetine D/R 30 mg capsules (also sold as Cymbalta) distributed nationwide because the drug contains N-nitroso-duloxetine impurity above FDA-recommended interim limits.

    Product
    DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0612-2026·2026-07-01

    Corlanor ivabradine tablets recalled for presence of foreign substance

    Amgen Inc. is recalling Corlanor (ivabradine) 5 mg tablets nationwide due to the presence of a foreign substance. The recall affects approximately 934,577 bottles distributed in the United States.

    Product
    CORLANOR — CORLANOR (IVABRADINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2596-2026·2026-07-01

    Medline 10mL Polycarbonate Syringes Recalled for Unapproved Design Changes

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The affected kits were distributed nationwide.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. FTMC C-SECTION TRAY-LF DYNJ54603B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0611-2026·2026-07-01

    Fenofibrate Capsules 200 mg Recalled for CGMP Manufacturing Deviations

    Ajanta Pharma USA Inc. is recalling Fenofibrate Capsules, USP 200 mg due to Current Good Manufacturing Practice (CGMP) deviations identified during production. The recall affects 3,648 bottles distributed nationwide.

    Product
    FENOFIBRATE — FENOFIBRATE (FENOFIBRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2526-2026·2026-07-01

    Multi-Snare Set catheter fails biocompatibility requirements

    PFM Medical Inc. is recalling Multi-Snare Set catheters (5 mm and 10 mm sizes) because they failed biocompatibility testing for in-vitro cytotoxicity and could cause localized inflammation and tissue irritation if they contact a patient's blood vessels.

    Product
    Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0609-2026·2026-07-01

    METHYLERGONOVINE MALEATE Tablets 0.2 mg Drug Recall

    The Harvard Drug Group LLC is recalling METHYLERGONOVINE MALEATE Tablets 0.2 mg because the drug may be subpotent (contain less active ingredient than intended). The recall affects approximately 790 cartons distributed nationwide.

    Product
    METHYLERGONOVINE MALEATE — METHYLERGONOVINE MALEATE (METHYLERGONOVINE MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2522-2026·2026-07-01

    Philips Avalon Fetal Monitor FM20 Speaker Connector Assembly Recall

    Philips is recalling certain Avalon Fetal Monitor FM20 units worldwide due to incorrect speaker connector assembly that can cause device cables to be pulled out, leading to loss of speaker output.

    Product
    Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
    Category
    Medical Device
    Distribution
    Distributed nationwide