State

Louisiana product recalls

73,092 recalls have nationwide distribution and so reach Louisiana. 6,958 additional recalls listed Louisiana specifically in their distribution scope.

What the numbers show

Total: 6,958
Critical: 1,109
Severe: 1,497
Most recent: 2026-09-23

Of the 6,958 recalls naming Louisiana we have scored against our rubric, 1,109 (16%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,497 (22%) are Severe.

Which agencies issued them

These figures cover only the 6,958 recalls whose distribution notice names Louisiana specifically. The 73,092 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

9976–10000 of 80050

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-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 (Drugs)·D-0663-2024·2024-10-02
Pyridoxine Injection Solution Recalled Due to Lack of Sterility Assurance
Empower Pharmacy is recalling a pyridoxine (B6) injection solution because sterility assurance could not be confirmed. The recalled product is lot 609763 with a beyond-use date of 04/18/2025.
Product
Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041 NDC 72627-2424-1.
Category
Drug
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 (Devices)·Z-3272-2024·2024-10-02
Esophageal stent systems recalled due to delivery catheter tip detachment risk
Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment during stent placement procedures.
Product
WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516300
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3278-2024·2024-10-02
FDA Recalls Esophageal Stent Systems Due to Delivery Catheter Tip Detachment Risk
Boston Scientific recalled 364 esophageal stent systems due to potential delivery catheter tip detachment during placement procedures. No injuries have been reported. Affected patients and providers should contact the manufacturer.
Product
WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- 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-3234-2024·2024-10-02
Medical Paracentesis Kit Recalled Over Sterilization Assurance Failure
504 paracentesis kits (Lot 2405102) are being recalled because the manufacturer cannot confirm that sterilization requirements were met during production.
Product
Paracentesis Thoracente, SLPT76H; Medical convenience kit
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-3250-2024·2024-10-02
Cook Biotech Biodesign Fistula Plug implants recalled for premature expiration
Cook Biotech is recalling Biodesign Fistula Plug C-FPB-0.4 implants because products expire before their printed expiration dates.
Product
Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24667
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3274-2024·2024-10-02
WallFlex Esophageal Stent System Recalled Due to Catheter Tip Detachment Risk
Boston Scientific recalls WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment affecting 77 units distributed worldwide.
Product
WALLFLEX FC ESO STENT RMV LL 23X155- 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-3255-2024·2024-10-02
Biodesign Fistula Plug Implants Recalled Due to Premature Expiration
Cook Biotech is recalling Biodesign Fistula Plug C-FPS-0.2-2 implants because affected units expire before their labeled expiration dates. The defect could compromise product performance.
Product
Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46374
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3257-2024·2024-10-02
Biodesign Fistula Plug implants recalled for premature expiration defect
Cook Biotech is recalling 130 units of Biodesign Fistula Plug C-FPS-0.7-2 surgical implants because the devices expire prior to the expiration date printed on the labeling. Devices were distributed worldwide including the US and 11 other countries.
Product
Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46373
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3241-2024·2024-10-02
American Contract Systems Recalls ENT Medical Convenience Kits Due to Sterilization Concerns
American Contract Systems is recalling 66 ENT medical convenience kits because humidity readings were out of specification, preventing confirmation of sterilization.
Product
ENT, COEN27N; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3197-2024·2024-10-02
MRI Device Ingenia Ambition S Screws May Loosen and Block Tabletop
Assembly screws in Philips Ingenia Ambition S MRI systems may loosen and protrude, potentially blocking the patient tabletop and delaying diagnosis. Philips is recalling 64 affected units worldwide.
Product
Ingenia Ambition S - 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) 782108 2) 781359 3) 782133
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3290-2024·2024-10-02
Esophageal stent systems recalled due to delivery catheter defect
Boston Scientific has recalled AGILE and WallFlex esophageal stent systems due to potential delivery catheter tip detachment. This defect could occur during stent deployment and affect proper stent placement.
Product
AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-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 concu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3245-2024·2024-10-02
FDA Recalls Surgical Instrument Handle That May Break During Use
The FDA is recalling LINK Universal Handles due to risk of material failure when first used. The surgical instrument may break during surgery, compromising patient safety.
Product
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3192-2024·2024-10-02
Biopsy instrument packaging holes compromise sterile barrier integrity
Argon Medical Devices recalls BioPince Ultra and Tru-Core II biopsy instruments due to holes in packaging trays compromising the sterile barrier, which may allow microorganism introduction and infection risk.
Product
BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-01, 370-1580-02, 370-1580-03; Tru-Core II Biopsy Instrument,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3216-2024·2024-10-02
ACUSON Redwood Ultrasound Systems Recall for Software Unit Conversion Error
Siemens ACUSON Redwood ultrasound systems may display measurements 10 times smaller than actual if operators change the software from factory defaults to milliliters per second or minute. This could lead to misdiagnosis and poor patient management.
Product
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
Category
Medical Device
Distribution
42 states
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-3213-2024·2024-10-02
Cervical disc implant recalled due to foreign contamination during assembly
Centinel Spine is recalling the Prodisc C SK cervical disc implant due to blue discoloration identified as foreign contamination on the inlay during assembly. The contamination was not fully evaluated in manufacturing validations.
Product
prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
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-3293-2024·2024-10-02
Boston Scientific Agile Esophageal Over-the-Wire Stent System recalled for catheter tip detachment
Boston Scientific is recalling the Agile Esophageal Over-the-Wire Stent System due to potential for delivery catheter tip detachment. Seven affected units distributed worldwide are identified by lot numbers 32889020 and 33178844.
Product
AGILE ESO FC RMV 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 concu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3203-2024·2024-10-02
MRI Diagnostic Device Screws May Loosen, Block Tabletop
Philips SmartPath to dStream 1.5T MRI devices may have loose assembly screws that could block the diagnostic tabletop and delay imaging. 32 units distributed worldwide.
Product
SmartPath to dStream for 1.5T - 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) 782112; 2) 781260
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3264-2024·2024-10-02
Stryker TMJ Unilateral Implant Recalled Due to Incorrect Components
TMJ Solutions Inc is recalling the Stryker TMJ Unilateral Implant because patient-fitted prostheses contained incorrect components. Patients should contact their healthcare provider immediately.
Product
Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, Mandibular Component, Right.
Category
Medical Device
Distribution
Distributed nationwide