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.

1001–1025 of 75997

  • SevereFDA (Devices)·Z-2583-2026·2026-07-01

    Medical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes used in surgical procedures. The manufacturer identified unapproved design changes to the products that were not cleared by the FDA through the 510(k) process.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J DYNJ905153K DYNJ905153L GYNE LAPAROTOMY PACK-LF DYNJ49593A LAPAROSCOPY DYNJ905157G DYNJ905157I DYNJ905157J LAPAROSCOPY PACK DYNJ56930B MAJOR PLUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2592-2026·2026-07-01

    Medline Polycarbonate Syringes in Convenience Kits Recalled for Unapproved Design Changes

    Medline Industries recalled multiple convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The company identified these modifications and notified the FDA of the deviation from the approved 510(k) design.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665D ANGIO PACK DYNJ30565D ANGIOGRAPHY PACK-LF DYNJ0854485V ARTERIOGRAM DYNJ28082D DYNJ28082F CARDIAC CATH DYNJ67349 CARDIA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-1105-2026·2026-07-01

    Spring & Mulberry Coffee Date-Sweetened Chocolate bars recalled for Salmonella

    Spring & Mulberry Inc. is recalling Spring & Mulberry Coffee Date-Sweetened Chocolate bars due to potential Salmonella contamination. The affected product was distributed nationwide.

    Product
    Spring & Mulberry Coffee Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a light brown box, UPC 850055470224, Dist. By Spring & Mulberry Raleigh, NC 27606. Wholesale product packed 48 bars (caddied)/56 bars (uncaddied) per case. Retail product sold indi
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2587-2026·2026-07-01

    Medline Convenience Kits with Syringes Recalled for Unapproved Design Changes

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside FDA-cleared specifications.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CRANIOTOMY PACK-LF DYNJ0101292F DYNJ0101292G HYBRID PACK DYNJ65925A LAMINECTOMY DYNJ905156L DYNJ905156M DYNJ905156N DYNJ905156O DYNJ905156P MAJOR EXTREMITY DYNJ905
    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-2531-2026·2026-07-01

    Zimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage

    Zimmer is recalling the Off-Axis Alliance Glenoid Right 4-Peg Augment Reamer Guide (Model 110040476) after five complaints that plastic guides broke during reaming.

    Product
    Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2567-2026·2026-07-01

    Surgify Halo surgical burrs recalled for potential breakage

    Surgify Halo 5.4 mm Short surgical burrs may break during bi-portal endoscopic spinal surgery. FDA Class II recall affects multiple U.S. states.

    Product
    Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2553-2026·2026-07-01

    GE Healthcare AW Server Radiological Image Processing System Software Defect

    GE Healthcare is recalling the AW Server 3.2 ext. 6.5 radiological image processing system due to a software synchronization issue that may cause the wrong patient's images to be displayed without warning, potentially leading to misdiagnosis.

    Product
    GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
    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-2565-2026·2026-07-01

    Surgify Halo Surgical Burr Recalling Potential Tool Breakage Risk

    SURGIFY MEDICAL OY is recalling the Surgify Halo 5.4 mm Extendable surgical burr due to risk of burr breakage during bi-portal endoscopic spinal surgery (BESS). The recalled units are distributed nationwide.

    Product
    Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.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-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 (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-2570-2026·2026-07-01

    Surgify Halo surgical burrs recalled for potential breakage risk

    Surgify Medical is recalling the Surgify Halo 5.4 mm surgical burrs due to potential breakage during spinal surgery procedures.

    Product
    Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1095-2026·2026-07-01

    Motor City Pizza Co. 5 Cheese Bread recalled for salmonella risk

    Champion Foods, LLC is recalling Motor City Pizza Co. 5 Cheese Bread due to potential salmonella contamination. Affected products were distributed nationwide at major retailers.

    Product
    Motor City Pizza Co. 5 Cheese Bread Single retail pack; 22.43 oz. (1 lb. 6.4 oz.) 636g UPC 8 70375 00511 1; 6 retail units per case Motor City Pizza Co. 5 Cheese Bread Twin retail pack; 44.86 oz. (2 lb. 12.9 oz.) 1272g UPC 8 70375 00509 8; 10 retail units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2556-2026·2026-07-01

    Surgify Halo surgical drill equipment recalled for potential burr breakage

    Surgify Halo 3.0 mm Short surgical drills and burrs are being recalled because they may break during bi-portal endoscopic spinal surgery, potentially leaving fragments in the patient.

    Product
    Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
    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-2569-2026·2026-07-01

    Surgify Halo Surgical Burrs Subject to Potential Breakage Recall

    Surgify Halo 5.4 mm surgical burrs may break during bi-portal endoscopic spinal surgery. The FDA has classified this as a Class II recall affecting devices distributed nationwide.

    Product
    Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2529-2026·2026-07-01

    Zimmer Off-Axis Comprehensive Shoulder System Reamer Guide Recall

    Zimmer, Inc. is recalling the Off-Axis Comprehensive Shoulder System reamer guides (Model 110040242) due to plastic guides that can catch and break during reaming. Five complaints have been received.

    Product
    Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2560-2026·2026-07-01

    Surgify Halo surgical burr recalled for potential breakage risk

    Surgify Medical is recalling the Surgify Halo 4.0 mm surgical burr because it may break during bi-portal endoscopic spinal surgery. The device is distributed nationwide.

    Product
    Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.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-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