State

US Virgin Islands product recalls

72,992 recalls have nationwide distribution and so reach US Virgin Islands. 177 additional recalls listed US Virgin Islands specifically in their distribution scope.

What the numbers show

Total: 177
Critical: 12
Severe: 30
Most recent: 2026-09-09

Of the 177 recalls naming US Virgin Islands we have scored against our rubric, 12 (7%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 30 (17%) are Severe.

Which agencies issued them

These figures cover only the 177 recalls whose distribution notice names US Virgin Islands specifically. The 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8976–9000 of 73169

HighFDA (Devices)·Z-0221-2025·2024-10-30
AD-TECH Spencer Probe Depth Electrodes recalled for MRI safety labeling error
Ad-Tech Medical Instrument Corporation is recalling 14 units of its AD-TECH Spencer Probe Depth Electrodes due to an incorrect MRI safety label. The devices were labeled as MRI Conditional when they are actually MRI Unsafe, creating a risk of misuse.
Product
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0176-2025·2024-10-30
Medline Medical Procedure Kits Recalled for Potential Non-Sterility Risk
Medline is recalling 88 convenience kits used in gynecological medical procedures due to potential non-sterility if the breather pouch seal is compromised. The affected lots are distributed in the US, Canada, and Panama.
Product
Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY TEGH-LF, REF DYNJ46730; b) HYSTEROSCOPY PACK, REF DYNJ49302A; c) PERI GYN PACK, REF DYNJ57526A; d) HYSTEROSCOPY TRAY ACS, REF DYNJ68750
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0226-2025·2024-10-30
Boston Scientific myLUX Patient Application Recalled for Data Transmission Failure
Boston Scientific is recalling the myLUX Patient Application for Apple mobile devices because it may fail to transmit cardiac monitor data to the LATITUDE Clarity website.
Product
Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0158-2025·2024-10-30
Medline Medical Procedure Kits Recalled for Potential Sterility Compromise
Medline is recalling specific medical procedure convenience kits because a packaging defect could allow non-sterile product to be used if the vendor seal is opened.
Product
Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY TRAY, REF DYNJ43076A; c) LOU LOOP RECORDER PACK, REF DYNJ49404C; d) CT BIOPSY, REF DYNJ52666C; e) BIOPSY KIT, REF DYNJ61130B; f) ASPEN SOFT TISSUE PACK, REF D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0135-2025·2024-10-30
Olympus Soltive Pro Laser Systems Recalled for Incorrect Bladder Stone Translation
Olympus is recalling Soltive Pro SuperPulsed Laser Systems because the term 'Bladder Stone' was incorrectly translated as 'Kidney Stone' in Spanish and Portuguese, posing a risk of unintended energy delivery.
Product
Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0077-2025·2024-10-30
Datex-Ohmeda Aespire View Anesthesia Machines Recalled for Connection Error Risk
Datex-Ohmeda is recalling 10,338 Aespire View anesthesia machines due to a potential issue where a patient breathing circuit limb may be mistakenly connected to the Auxiliary Common Gas Outlet port.
Product
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0084-2025·2024-10-30
Datex-Ohmeda Auxiliary Common Gas Outlet Conversion Kits Recalled
Datex-Ohmeda is recalling 649 Auxiliary Common Gas Outlet (ACGO) conversion kits due to a potential issue if a patient breathing circuit limb is mistakenly connected to the ACGO port.
Product
Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due to being purchased with or later used to convert to ACGO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0156-2025·2024-10-30
Medline Medical Procedure Kits Recalled for Potential Non-Sterility Risk
Medline is recalling certain medical procedure kits packaged in breather pouch lot 323080002 because seals may not prevent non-sterile product use. Affected units were distributed in the US, Canada, and Panama.
Product
Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT, REF DYNDC2486A; a) OPEN HEART PACK, REF DYNJ01201L; a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G; a) COTTON ROLL KIT-LF, REF DYNJ3272
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0136-2025·2024-10-30
Ultrasound Systems Recalled for Loose Power Connections Causing Thermal Hazard
B-K Medical A/S is recalling 1,648 ultrasound systems due to loose power connections that can cause excessive heat and potential thermal events.
Product
bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0155-2025·2024-10-30
Medline Medical Procedure Kits Recalled for Potential Non-Sterile Product
Medline brand medical procedure convenience kits are recalled because their packaging may allow product sterility to be compromised. The affected units were packaged in breather pouch lot 323080002.
Product
Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH PACK-LF, REF DYNJ19010I; c) SUPPLEMENTAL NEURO ANGIO PK, REF DYNJ29207; d) ANGIO PACK, REF DYNJ43661C; e) LEFT HEART CATH TEGH-LF, REF DYNJ46746C; f) L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0154-2025·2024-10-30
Medline Medical Procedure Convenience Kits Recalled for Potential Sterility Issue
Medline is recalling 312 medical procedure convenience kits due to potential sterility issues if the breather pouch seal is opened or damaged. The affected kits were distributed in the US, Canada, and Panama.
Product
Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF DYNJ36320A; b) ANGIOGRAM WRO-LF, REF DYNJ41876B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0219-2025·2024-10-30
AD-TECH Spencer Probe Depth Electrode Recalled for MRI Safety Labeling Error
Ad-Tech is recalling Spencer Probe Depth Electrodes due to an incorrect MRI safety label. The device was incorrectly labeled as MR Conditional when it is actually MR Unsafe and not cleared for MRI use.
Product
AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0220-2025·2024-10-30
AD-TECH Spencer Probe Depth Electrode recalled for MRI safety label discrepancy
Ad-Tech is recalling A-style depth electrodes due to incorrect MRI safety labeling. Devices were labeled as MR Conditional when they should be labeled MR Unsafe.
Product
AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0157-2025·2024-10-30
Medline medical procedure kits recalled due to potential non-sterile packaging defect
Medline brand medical procedure convenience kits packaged in breather pouch lot 323080002 may be non-sterile if the vendor seal is opened or compromised. Affected kits are distributed in the US, Canada, and Panama.
Product
Medline brand medical procedure convenience kits, labeled as: a) KIT LINE INSERTION, REF CVI4730A; b) KIT LINE INSERTION, REF CVI4730A; c) LINE INSERTION TRAY, REF DYNJ20803D; d) CENTRAL LINE PACK-LF, REF DYNJ28368; e) CENTRAL LINE PACK-LF, REF DYNJ28368; f) PICC PAC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0171-2025·2024-10-30
Medline Medical Procedure Drape Packs Recalled Due to Non-Sterile Packaging Risk
Medline is recalling 194 drape packs from breather pouch lot 323080002 that may be non-sterile if the seal is opened. The kits were distributed in the US, Canada, and Panama.
Product
Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0164-2025·2024-10-30
Medline catheter procedure kits recalled for potential sterility compromise
Medline is recalling 8,830 medical procedure convenience kits with potential breather pouch seal failure that could allow non-sterile product use.
Product
Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b) TRAY FOL LATX UM COUD 16FR MF, REF DYND150216CS; c) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S; d) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0016-2025·2024-10-30
Phenylephrine Injection Recalled Due to Manufacturing Quality Violations
Fresenius Kabi Compounding recalled phenylephrine HCl injectable due to cGMP violations. The recall affects 2,756 doses distributed to 125 direct accounts nationwide.
Product
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0175-2025·2024-10-30
Medline medical procedure kits recalled due to potential non-sterile product risk
Medline is recalling four types of medical procedure convenience kits that may contain non-sterile products if the pouch seal is opened. Approximately 197 units were distributed nationwide and internationally.
Product
Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B; c) GYN ANCILARY PACK, REF DYNJ84509; d) GYN LITHOTOMY MINOR, REF DYNJ907707
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0160-2025·2024-10-30
Medline Medical Procedure Kits Recalled Due to Non-Sterile Packaging Risk
Medline Industries is recalling 2,740 surgical convenience kits with breather pouches that may result in non-sterile product if the vendor seal is opened. The recall affects units distributed in the US, Canada, and Panama.
Product
Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I; 2) TONSIL CDS, REF CDS984492B; 3) RV T&A PACK-LF, REF DYNJ0798129I; 4) DIRECT MICRO LARYNG PK-LF, REF DYNJ30591I; 5) APU LINE PACK, REF DYNJ37171A; 6) T&A PACK-LF, REF DYNJ40
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0180-2025·2024-10-30
Medline EYE PACK Medical Kits Recalled for Potential Non-Sterile Packaging
Medline is recalling 160 units of EYE PACK medical procedure kits due to potential compromises in sterilization. If the vendor seal on the breather pouch is opened or unsealed, the contents may become non-sterile.
Product
Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0017-2025·2024-10-30
Phenylephrine HCl Injectable Drug Recalled for Manufacturing Practice Violations
Fresenius Kabi is recalling 1,378 bags of phenylephrine HCl injection due to manufacturing violations. The recall affects 125 healthcare facilities nationwide.
Product
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0224-2025·2024-10-30
Quantum Perfusion Systems CPB Roller Pumps Recalled for Mechanical Locking Defect
Spectrum Medical Ltd. is recalling 172 Quantum Perfusion Systems CPB Roller Pumps due to an out-of-tolerance ratchet and pawl defect preventing proper bobbin locking. This defect may affect blood circulation control during cardiac surgery.
Product
Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0153-2025·2024-10-30
Medline Procedure Kits Recalled for Non-Sterile Product Risk
Medline medical procedure kits may contain non-sterile product if the breather pouch seal is opened or compromised. The recall affects 320 units distributed in the US, Canada, and Panama.
Product
Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1854A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0170-2025·2024-10-30
Medline Tubal Ligation Kits Recalled for Potential Sterility Compromise
Medline is recalling certain tubal ligation procedure kits due to potential loss of sterility if the pouch seal becomes compromised during storage or handling.
Product
Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0024-2025·2024-10-30
Dietary supplement tablets recalled for undeclared diclofenac and acetaminophen
AK Forte Ortiga y Omega 3 tablets are recalled nationwide for containing undeclared diclofenac and acetaminophen without FDA approval. Consumers should stop using this product immediately.
Product
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
Category
Drug
Distribution
Distributed nationwide