State

South Dakota product recalls

72,992 recalls have nationwide distribution and so reach South Dakota. 2,681 additional recalls listed South Dakota specifically in their distribution scope.

What the numbers show

Total: 2,681
Critical: 401
Severe: 565
Most recent: 2026-09-02

Of the 2,681 recalls naming South Dakota we have scored against our rubric, 401 (15%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 565 (21%) are Severe.

Which agencies issued them

These figures cover only the 2,681 recalls whose distribution notice names South Dakota specifically. The 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

9426–9450 of 75673

HighFDA (Devices)·Z-3288-2024·2024-10-02
Boston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Detachment Risk
Boston Scientific is recalling Agile Esophageal Stent Systems because the delivery catheter tip may detach. The recall affects 15 units distributed worldwide.
Product
AGILE ESO OTW PC 23MM X 10.1CM 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-3202-2024·2024-10-02
Philips MR 7700 MRI Scanner Recall for Loose Screws
Philips is recalling 7 MR 7700 MRI scanners because loose screws may block the tabletop, potentially delaying diagnosis or causing patient anxiety.
Product
MR 7700 -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: 782120
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3269-2024·2024-10-02
Boston Scientific Recalls WallFlex Esophageal Stent Systems Due to Catheter Tip Detachment
Boston Scientific is recalling WallFlex and Agile esophageal stent systems because the delivery catheter tip may detach. The recall covers 176 units distributed worldwide.
Product
WALLFLEX FC ESO STENT RMV 23X125MM- 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 esoph
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3281-2024·2024-10-02
Boston Scientific Recalls WallFlex Esophageal Stents Due to Catheter Tip Detachment
Boston Scientific is recalling WallFlex and Agile esophageal stent systems because the delivery catheter tip may detach during use.
Product
WALLFLEX PC ESOPH STENT 18/23MM X 103MM- 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-3230-2024·2024-10-02
American Contract Systems Recalls Open Shoulder Medical Convenience Kits
American Contract Systems is recalling 12 Open Shoulder medical convenience kits because a faulty chart recorder prevented verification of sterilization requirements.
Product
Open Shoulder, LWOS39L; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3204-2024·2024-10-02
MRI Diagnostic Device Loose Screws May Block Patient Tabletop
Philips SmartPath dStream MRI devices have loose screws in the RF carrier assembly that may interfere with the moving tabletop, potentially delaying diagnosis. Affected units should be inspected and repaired immediately.
Product
SmartPath to dStream for XR and 3.0T- 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) 782113; 2) 781270; 3) 782129
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-3191-2024·2024-10-02
Custom Procedure Kit Sheath Introducers Mislabeled by Size
Merit Medical Systems is recalling Custom Procedure Kits (REF: K12T-11077) with 7F sheath introducers that are incorrectly labeled as 7.5F, a labeling discrepancy affecting 24 units distributed nationwide.
Product
Custom Procedure Kit, REF: K12T-11077
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3268-2024·2024-10-02
FDA Recalls Esophageal Stent Systems for Potential Catheter Tip Detachment
Boston Scientific's Wallflex and Agile esophageal stent systems are recalled due to the potential for delivery catheter tip detachment. The recall affects 146 units distributed worldwide.
Product
WALLFLEX FC ESO STENT RMV 23X105MM- 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 esoph
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-3195-2024·2024-10-02
Philips Ingenia 3.0T MRI Scanner Tabletop Blockage Risk
Philips is recalling 33 Ingenia 3.0T MRI scanners whose Integrated Radio Frequency Carrier assembly screws may come loose and block the horizontal tabletop, potentially causing diagnostic delays.
Product
Ingenia 3.0T - 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: 782103
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3300-2024·2024-10-02
Custodiol HTK Solution Recalled for Potential Particle Contamination
Custodiol HTK Solution is subject to a Class II recall due to the potential for particles in the solution. The affected product consists of 48 cartons distributed in North Carolina.
Product
Custodiol HTK Solution, 500ml bottle. 10 per carton.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0664-2024·2024-10-02
FDA Recalls Refresh P.M. Eye Ointment Due to Potential Sterility Breach
AbbVie is recalling Refresh P.M. lubricant eye ointment due to potential breaches in tube seals that may compromise product sterility. Approximately 2.4 million tubes were distributed nationwide and internationally.
Product
Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043,
Category
Drug
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-3232-2024·2024-10-02
Medical Device Kit Recall: Sterilization Assurance Cannot Be Confirmed
American Contract Systems is recalling 60 Shoulder SESH18I medical convenience kits nationwide due to equipment failure that resulted in out-of-specification humidity readings, preventing sterilization assurance confirmation.
Product
Shoulder, SESH18I; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3231-2024·2024-10-02
Day Surgery General Pack medical kit recalled for sterilization concern
American Contract Systems recalled 280 units of its Day Surgery General Pack due to humidity control failures that prevent confirmation of adequate sterilization.
Product
Day Surgery General Pack, FHGE18T; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3193-2024·2024-10-02
MRI Diagnostic Device Recalls Due to Loose Screw Assembly Risk
Philips recalls Evolution Upgrade 3.0T MRI devices due to loose screws that may block the tabletop and delay diagnosis. Devices with the affected serial numbers should be taken out of service.
Product
Evolution Upgrade 3.0T - 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) 782117 (2) 782143
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3260-2024·2024-10-02
Biodesign Recto-Vaginal Fistula Plug Recalled for Premature Expiration
Cook Biotech is recalling 8 units of Biodesign Recto-Vaginal Fistula Plug devices because they expire before the date printed on the label. The affected products may lose sterility if used after actual expiration.
Product
Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46603
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3215-2024·2024-10-02
Siemens ACUSON Juniper ultrasound systems software unit conversion error
Siemens is recalling ACUSON Juniper ultrasound systems that may perform incorrect unit conversions when configured with non-default settings, potentially producing measurements 10 times smaller than actual values and risking patient misdiagnosis.
Product
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software.
Category
Medical Device
Distribution
42 states
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-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-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-3297-2024·2024-10-02
CooperSurgical Recalls Origio Sperm Wash Medium Due to Low Sodium Pyruvate
CooperSurgical is recalling Origio Sperm Wash Medium because low sodium pyruvate levels could compromise gamete development.
Product
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A
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-3242-2024·2024-10-02
Nasal Sinus Pack Recalled Due to Sterilization Verification Failure
American Contract Systems is recalling Nasal Sinus Pack units due to manufacturing control failures that prevent confirmation of sterilization. Affected units were distributed to multiple states.
Product
Nasal Sinus Pack, MTSN26B; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide