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.

Which agencies issued them

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.

4676–4700 of 76030

  • HighFDA (Devices)·Z-0211-2026·2025-10-29

    Gastroduodenal sump tubes recalled after anti-reflux valve breakage complaints

    Cardinal Health is recalling all lots of Salem Sump PVC gastroduodenal tubes after complaints of anti-reflux valve breakage due to excessive force during use.

    Product
    Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 1180264416 Salem Sump" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm 1180264424 Salem Sump" PVC Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0234-2026·2025-10-29

    Prefilled saline flush syringes recalled over sodium chloride concentration shortfall

    Medline is recalling 8,267,150 Excelsior Medical 0.9% Sodium Chloride prefilled flush syringes because a limited quantity may not meet the required concentration of sodium chloride.

    Product
    Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0210-2026·2025-10-29

    Dual lumen stomach tubes recalled after anti-reflux valve breakage complaints

    Cardinal Health is recalling all lots of Salem Sump dual lumen stomach tubes with anti-reflux valve after complaints of valve breakage due to excessive force during use.

    Product
    Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) 266130 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 16 Fr/Ch (5.3 mm) 266148 Salem Sump" Stomach Tube, Dual Lumen with Anti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0216-2026·2025-10-29

    Immunoassay analyzers recalled over dilution factor anomaly affecting patient results

    Beckman Coulter is recalling 571 DxI 9000 Access Immunoassay Analyzers over a software anomaly that may not apply user-specified manual dilution factors, risking false low or high results.

    Product
    DxI 9000 Access Immunoassay Analyzer, Part Number C11137
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0239-2026·2025-10-29

    Automated microbiology systems recalled after service credentials were accessed by unauthorized actor

    Becton Dickinson is recalling 4,283 BD Phoenix M50 Automated Microbiology Systems after product service credentials used by some technical support teams were accessed by an unauthorized actor.

    Product
    BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0233-2026·2025-10-29

    Oral thermometer probes recalled after being programmed with rectal configuration

    Baxter is recalling 5,209 oral probes for Welch Allyn SureTemp Plus thermometers that were inadvertently programmed with the rectal probe configuration and may read low.

    Product
    Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch Allyn SureTemp Plus 692 (01692-200) thermometers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0232-2026·2025-10-29

    Insulin pumps recalled over software defect causing unexpected correction bolus

    Tandem Diabetes Care is recalling 122,958 t:slim X2 and Mobi insulin pumps because a software defect when paired with a Dexcom G7 sensor may trigger an unexpected automatic correction bolus.

    Product
    t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor; Tandem Mobi insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014801, 1014811, 1014813, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0235-2026·2025-10-29

    Microbiology data systems recalled after service credentials accessed by unauthorized actor

    Becton Dickinson is recalling 2,050 BD EpiCenter Microbiology Data Management Systems after product service credentials used by some technical support teams were accessed by an unauthorized actor.

    Product
    BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC 2, Catalog Number: 445398. 4. Nuc 5i5 Os Image Bow 2.X, C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0035-2026·2025-10-29

    Alcohol prep pads recalled from one lot as a subpotent drug

    Medline is recalling 222,800 alcohol prep pads from one lot because the product is subpotent.

    Product
    Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, 60093 USA, NDC 55329-811-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0231-2026·2025-10-29

    ECG trunk cables recalled because improper module placement can cause overheating

    GE is recalling 29,225 MAC VU360 acquisition trunk cables and module holders because incorrect placement of the module can wear the cable until it overheats in use.

    Product
    MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0209-2026·2025-10-29

    Gastric sump anti-reflux valves recalled after breakage complaints from excessive force

    Cardinal Health is recalling all lots of Salem Sump Anti-Reflux Valves after complaints of valve breakage due to excessive force during use, and is providing additional guidance for use.

    Product
    Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0227-2026·2025-10-29

    Bipolar hip heads recalled downstream after femoral components failed transit testing

    Theken Companies is recalling 409 iNSitu Bipolar Hip System head assemblies in a downstream recall after BioPro femoral components failed transit testing, risking sterile barrier issues.

    Product
    iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Asse
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0097-2026·2025-10-29

    Opdualag injection vials recalled from one lot over sterility assurance

    Bristol-Myers Squibb is recalling 12,778 vials of Opdualag (nivolumab and relatlimab-rmbw) injection from one lot for lack of assurance of sterility.

    Product
    OPDUALAG — OPDUALAG (NIVOLUMAB AND RELATLIMAB-RMBW)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0215-2026·2025-10-29

    Clinical analyzer modules recalled over dilution factor software anomaly affecting results

    Beckman Coulter is recalling 160 DxC 500i Clinical Analyzer modules over a software anomaly that may not apply user-specified manual dilution factors, risking false low or high results.

    Product
    DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0206-2026·2025-10-29

    ENFit sump tubes recalled after anti-reflux valve breakage complaints

    Cardinal Health is recalling all lots of ENFit Salem Sump PVC tubes after complaints of anti-reflux valve breakage due to excessive force during use.

    Product
    Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN 8888264986E ENFit" SA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0208-2026·2025-10-29

    Silicone stomach tubes recalled after anti-reflux valve breakage complaints

    Cardinal Health is recalling all lots of Salem Sump silicone dual lumen stomach tubes after complaints of anti-reflux valve breakage due to excessive force during use.

    Product
    Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm) 8888265116 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 12 Fr/Ch (4.0 mm), 48 (122 cm) 8888265124 Salem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0207-2026·2025-10-29

    PVC stomach tubes recalled after anti-reflux valve breakage complaints

    Cardinal Health is recalling all lots of Salem Sump dual lumen stomach tubes after complaints of anti-reflux valve breakage due to excessive force during use.

    Product
    Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm) 264960 Salem Sump" Stomach Tube, Dual Lumen, 16 Fr/Ch (5.3 mm) 264986 Salem Sump" Stomach Tube, Du
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0238-2026·2025-10-29

    BD MAX instruments recalled after service credentials accessed by unauthorized actor

    Becton Dickinson is recalling 62 BD MAX System instruments after product service credentials used by some technical support teams were accessed by an unauthorized actor.

    Product
    BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0237-2026·2025-10-29

    Blood culture systems recalled after service credentials were accessed by unauthorized actor

    Becton Dickinson is recalling 1,086 BD BACTEC Blood Culture Systems after product service credentials used by some technical support teams were accessed by an unauthorized actor.

    Product
    BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number: 44557008.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0240-2026·2025-10-29

    Veritor Connect software recalled after service credentials accessed by unauthorized actor

    Becton Dickinson is recalling 38 BD Veritor Connect Software units after product service credentials used by some technical support teams were accessed by an unauthorized actor.

    Product
    BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the BD Veritor Plus Analyzer to BD Synapsys.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0236-2026·2025-10-29

    BACTEC FX instruments recalled after service credentials accessed by unauthorized actor

    Becton Dickinson is recalling 177 BD BACTEC Blood Culture System instruments after product service credentials used by some technical support teams were accessed by an unauthorized actor.

    Product
    BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676. 3. BACTEC 9240 System, Catalog Number: 445569. 4. BD BACTEC FX40 Instrum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0036-2026·2025-10-29

    Ketorolac injection vials recalled after glass particulate found in product

    Aspiro Pharma is recalling Ketorolac Tromethamine Injection USP 60 mg/2 mL across several lots because of particulate matter identified as glass.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0032-2026·2025-10-29

    Cetirizine hundred count bottles recalled over tablets imprinted with wrong identifier

    JB Chemicals is recalling 9,936 hundred-count bottles of Cetirizine Hydrochloride Tablets USP 10 mg because the tablets were imprinted with the wrong identification code.

    Product
    CETIRIZINE HYDROCHLORIDE — CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0228-2026·2025-10-29

    Forty six millimetre locking screws recalled over wrong length on packaging

    Synthes is recalling 120 low profile locking screws because 42mm screws were packaged and labeled as 46mm and 46mm screws were labeled as 42mm, though the etched length is correct.

    Product
    LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.
    Category
    Medical Device
    Distribution
    Distributed nationwide