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.

9301–9325 of 73169

HighFDA (Devices)·Z-3200-2024·2024-10-02
MRI Scanner Loose Screws May Block Tabletop and Delay Diagnosis
The Ingenia Elition X MRI device may have loose screws that interfere with the horizontal tabletop, potentially delaying patient diagnosis and causing anxiety during extended bore exposure.
Product
Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782151; 2) 782119; 3) 781358; 4) 782107; 5) 78213
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3218-2024·2024-10-02
Karl Storz Hopkins Telescope 6 endoscope with unapproved reprocessing instructions
Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.
Product
Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3239-2024·2024-10-02
Medical Cath Lab Pack Recalled Due to Sterilization Assurance Failure
American Contract Systems is recalling Cath Lab Pack CECL02P medical kits because an inoperable chart recorder caused humidity readings to be out-of-specification, preventing confirmation that sterilization requirements were met.
Product
Cath Lab Pack, CECL02P; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3243-2024·2024-10-02
Medical device kit recalled due to inability to confirm sterilization assurance
American Contract Systems recalled its Cysto medical convenience kit (36 units, Lot 2405033) due to a humidity monitoring failure that prevented confirmation of adequate product sterilization.
Product
Cysto, FTCY03L; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3221-2024·2024-10-02
Medical endoscope recalled for unapproved sterilization instructions
Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing methods that lack FDA review and approval.
Product
Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3277-2024·2024-10-02
Boston Scientific Esophageal Stent Systems Recalled for Catheter Detachment Risk
Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment. The recall affects 79 units distributed worldwide.
Product
WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3279-2024·2024-10-02
Boston Scientific esophageal stent systems recalled for catheter tip detachment
Boston Scientific is recalling Wallflex and Agile esophageal stent systems due to potential delivery catheter tip detachment during stent placement procedures.
Product
WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3201-2024·2024-10-02
Philips MR 5300 MRI System Recalled for Loose Assembly Screws
Philips is recalling 68 MR 5300 MRI diagnostic systems worldwide because loose screws in the RF carrier assembly could block equipment movement and delay patient diagnosis.
Product
MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782110
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3302-2024·2024-10-02
Cardinal Health Salem Sump Stomach Tubes Recalled for Anti-Reflux Valve Breakage
Cardinal Health is recalling Salem Sump Dual Lumen Stomach Tubes due to reports of anti-reflux valve breakage caused by improper use. Product labeling has been updated.
Product
(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888266114, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888266122,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3287-2024·2024-10-02
Esophageal Stent Systems Recalled for Potential Delivery Catheter Detachment
Boston Scientific is recalling esophageal stent systems due to potential delivery catheter tip detachment during placement. Patients and providers with affected devices should contact the manufacturer for guidance.
Product
AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of con
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3275-2024·2024-10-02
Boston Scientific Esophageal Stents Recalled for Catheter Tip Detachment Risk
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The recall affects 231 units distributed worldwide.
Product
WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent e
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3248-2024·2024-10-02
Hologic Recalls Selenia Dimensions and 3Dimensions Breast Imaging Software
Hologic is recalling Selenia Dimensions and 3Dimensions software due to a defect that may cause blurry images and potential misdiagnosis.
Product
Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows Model/Catalog Number: 1. ASY-16824 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.1 SYSTEMS 2. ASY-16825 FMI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0668-2024·2024-10-02
Prescription immunosuppressant tablets recalled due to failed dissolution specifications
Ascend Laboratories recalled 117,493 bottles of Mycophenolic Acid tablets nationwide because the tablets failed to meet dissolution specifications. Patients taking this medication should consult their doctor.
Product
MYCOPHENOLIC ACID — MYCOPHENOLIC ACID (MYCOPHENOLIC ACID)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3251-2024·2024-10-02
Cook Biotech Fistula Plug recalled for expiring before labeled date
Cook Biotech is recalling 3 units of Biodesign Fistula Plug surgical implants because they expire before the printed expiration date. The devices were distributed worldwide.
Product
Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3259-2024·2024-10-02
Biodesign Recto-Vaginal Fistula Plug units expire before labeled date
Cook Biotech recalls Biodesign Recto-Vaginal Fistula Plug RVP-0.4 units because they expire before their labeled expiration dates. Affected lots were distributed worldwide.
Product
Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3267-2024·2024-10-02
Boston Scientific esophageal stents recalled due to catheter tip detachment risk
Boston Scientific is recalling Wallflex and Agile esophageal stent systems due to potential detachment of the delivery catheter tip during stent placement. These devices are used to maintain patency in esophageal strictures caused by malignant tumors or esophageal fistulas.
Product
WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esopha
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3236-2024·2024-10-02
Neuro Vascular Medical Kit Recalled for Sterilization Assurance Failure
American Contract Systems recalls the Neuro Vascular ANKV91A medical convenience kit due to inability to confirm sterilization. Affected units were distributed across MO, MN, MA, OH, and NE.
Product
Neuro Vascular, ANKV91A; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3198-2024·2024-10-02
Philips Ingenia Ambition X MRI Scanner Recalled Due to Loose Screws
Philips is recalling 63 units of the Ingenia Ambition X MRI scanner due to loose screws in the IRF carrier assembly that may block the imaging tabletop and potentially delay diagnosis.
Product
Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782109
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3244-2024·2024-10-02
Pacemaker COPM11B Medical Kits Recalled for Sterilization Verification Issue
American Contract Systems is recalling 3 units of the COPM11B pacemaker medical kits due to inability to confirm sterilization requirements were met. An inoperable chart recorder caused humidity readings to exceed specifications during manufacturing.
Product
Pacemaker, COPM11B; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3228-2024·2024-10-02
Endovascular AAA Pack recalled for sterilization assurance failure
American Contract Systems recalls 360 units of Endovascular AAA Pack due to inability to confirm sterilization requirements were met. An inoperable chart recorder prevented verification that environmental conditions during sterilization met required specifications.
Product
Endovascular AAA Pack, ESED52B; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3266-2024·2024-10-02
WallFlex and Agile Esophageal Stent Systems Recalled for Catheter Tip Detachment
Boston Scientific recalls WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The affected stents treat esophageal strictures and may cause procedural complications if detachment occurs.
Product
WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esopha
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3276-2024·2024-10-02
Boston Scientific Esophageal Stents Recalled for Delivery Catheter Tip Detachment
Boston Scientific is recalling Wallflex and Agile Esophageal Stent Systems due to potential for delivery catheter tip detachment. The recall involves 124 units distributed worldwide.
Product
WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3271-2024·2024-10-02
WallFlex Esophageal Stent System Recalled for Potential Catheter Tip Detachment
Boston Scientific Corporation is recalling WallFlex Esophageal Stent Systems and Agile Esophageal Over-the-Wire Stent Systems due to potential delivery catheter tip detachment during insertion procedures.
Product
WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esop
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3286-2024·2024-10-02
WallFlex and Agile esophageal stent systems recalled for delivery catheter tip detachment
Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential for delivery catheter tip detachment during insertion.
Product
WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3246-2024·2024-10-02
BD Phoenix M50 may misidentify E. coli bacteria in clinical samples
The BD Phoenix M50 instruments may misidentify Escherichia coli (E. coli) in clinical samples, potentially causing misdiagnosis and inappropriate treatment. About 4,295 affected units were distributed worldwide.
Product
BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number:
Category
Medical Device
Distribution
Distributed nationwide