State

South Dakota product recalls

72,986 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 72,986 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8301–8325 of 75667

HighFDA (Drugs)·D-0156-2025·2025-01-01
Duloxetine Delayed-Release Capsules Recalled Due to N-nitroso Impurity Contamination
Amerisource Health Services is recalling certain lots of Duloxetine Delayed-Release Capsules due to N-nitroso impurity levels exceeding recommended limits. Consumers with the medication should contact their healthcare provider.
Product
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0719-2025·2025-01-01
Surgical Patties and Strips Recalled for Endotoxin Contamination
Medline Industries recalls DIEP FLAP Convenience kits containing surgical patties and strips due to higher-than-expected endotoxin contamination that may not meet sterile product specifications.
Product
DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0766-2025·2025-01-01
EMPOWR 3D Knee Tibial Insert Package Mix-Up Causes Surgical Delays
Encore Medical recalls EMPOWR 3D Knee Tibial Insert packages that may contain the wrong size implant (5R 16MM with 3R 14MM and vice versa), potentially delaying surgery. The recall affects 33 units nationwide.
Product
EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0724-2025·2025-01-01
Medline Surgical Patties and Strips Recalled for Out-of-Spec Endotoxin Contamination
Medline is recalling surgical patties and strips in custom surgical kits due to higher-than-expected endotoxin levels in raw materials. These may result in out-of-specification endotoxin levels in finished sterile products.
Product
Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; 2) NEURO KIT, SKU CDS981327Q; 3) NEURO POSTERIOR SPINE PACK-LF, SKU DYNJ0311501I; 4) ACOUSTIC NEUROMA PACK-LF, SKU DYNJ37741D; 5) SCRIPPS SW NEURO PACK-LF, SKU D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0753-2025·2025-01-01
Merlin PCS 3650 Pacemaker Programmer Software Anomaly May Cause Loss of Pacing
A software anomaly in Abbott's Merlin PCS 3650 programmer may prevent proper finalization of leadless pacemakers, causing loss of pacing function. The issue occurs when specific actions combine with brief telemetry loss.
Product
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0757-2025·2025-01-01
Sterile Magill Forceps Recalled Due to Weak Seals and Contamination Risk
Medline has recalled Sterile Magill Forceps (Item No. 66790) due to weak seals that may compromise sterility. The defect affects approximately 21,440 units distributed nationwide.
Product
STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0755-2025·2025-01-01
Medline Surgical Scissors Recalled for Sterility Seal Defect
Medline O.R. scissors may have weak seals that compromise sterility, increasing risk of contamination and infection. Approximately 21,440 units from lot 2023052490 have been recalled nationwide.
Product
O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0740-2025·2025-01-01
Siemens Blood Analysis Device Recalled Over Patient Name Mix-up Software Defect
Siemens is recalling the epoc NXS blood analysis system due to a software flaw that can assign incorrect patient names to test results, risking misdiagnosis or mistreatment if the operator doesn't verify the patient name.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0718-2025·2025-01-01
Surgical patties and strips recalled due to endotoxin contamination
Medline Industries is recalling FESS-MB PACK-LF Convenience kits containing surgical patties and strips due to higher-than-expected endotoxin levels in raw materials, resulting in out-of-specification finished products.
Product
FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0739-2025·2025-01-01
Blood Analysis System Software Error Can Assign Wrong Patient Name
Siemens epoc NXS Host blood analysis devices have a software malfunction that may assign the wrong patient name to blood test results, potentially leading to misdiagnosis or mistreatment.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or ca
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0767-2025·2025-01-01
Siemens magnesium reagent cartridges recalled for false measurement results
Siemens is recalling two lots of Magnesium Flex reagent cartridges due to potential falsely low magnesium measurements. The intermittent error may not be detected by standard quality control procedures.
Product
Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0155-2025·2025-01-01
Duloxetine Delayed-Release Capsules Recalled for Nitrosamine Impurity
Amerisource Health Services LLC is recalling Duloxetine Delayed-Release Capsules 30 mg nationwide due to N-nitroso-duloxetine impurity above recommended limits. Patients should contact their healthcare provider.
Product
Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0720-2025·2025-01-01
Medline surgical procedure kits recalled due to endotoxin contamination
Medline brand surgical procedure convenience kits in specific lots contain higher-than-expected endotoxin levels in surgical patties and strips. The contamination was found in raw materials used to produce sterile components.
Product
Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU DYNJ33520A; 4) SINUS PACK, SKU DYNJ44845G; 5) SINUS PACK, SKU DYNJ48330B; 6) ENT PACK, SKU DYNJ50572; 7) ENT PACK, SKU DYNJ53573A; 8
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0754-2025·2025-01-01
Sterile Kelly Hemostat Recalled Due to Weak Seals
Medline's STERILE STRT KELLY HEMOSTAT (SK8039S) is being recalled due to weak seals that could compromise sterility, increasing the risk of contamination and infection. The recall affects 21,440 units distributed nationwide.
Product
STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0737-2025·2025-01-01
Blood Analysis System Software Malfunction May Assign Incorrect Patient Names
Siemens epoc NXS Host blood analysis systems contain a software malfunction that may assign incorrect patient names to blood measurements. This could result in clinicians making treatment decisions based on the wrong patient's test results.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0745-2025·2025-01-01
BD FACSLyric 2L4C Flow Cytometer Power Supply Failure Recall
BD FACSLyric 2L4C flow cytometers with specific power supplies (part 650781) may fail to power on or stay on. Potential fume inhalation could cause respiratory symptoms in laboratory staff.
Product
FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for in vitro diagnostic for the following: " Immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0762-2025·2025-01-01
MISHA Knee System Implants recalled due to fracture risk
Moximed is recalling 115 MISHA Knee System Implants in multiple US states due to a supplier component defect that may cause the implant to fracture, potentially leading to pain, swelling, and stiffness.
Product
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0749-2025·2025-01-01
BD FACSLyric Flow Cytometer Power Supply Failure Risk
BD is recalling FACSLyric flow cytometer power supplies that may fail to power on or stay on, creating risks of fume inhalation and requiring patients to return for repeat biospecimen collection procedures.
Product
FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0161-2025·2025-01-01
Duloxetine 30mg Capsules Recalled Due to Nitrosamine Impurity
Breckenridge Pharmaceutical is recalling 163,883 bottles of Duloxetine 30mg capsules nationwide due to N-nitroso-duloxetine impurity above FDA-recommended limits.
Product
DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0752-2025·2025-01-01
FDA Recalls Medical Spine Component Due to Manufacturing Defects
SEASPINE Orthopedics is recalling 191 Daytona Small Stature Ti Locking Caps due to manufacturing defects that prevent proper component mating.
Product
Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 Software Version: N/A Product Description: Locking Cap Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0728-2025·2025-01-01
O&M Halyard Procedure Masks Recalled for Unmet Bioburden Testing Requirements
O&M HALYARD is recalling O&M Halyard Procedure Masks (Product Code 47117) nationwide because they do not meet bioburden testing requirements printed on the packaging.
Product
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0721-2025·2025-01-01
Medline Surgical Patties and Strips Recalled for Endotoxin Contamination
Medline recalls surgical patties and strips from specific kit lots due to higher-than-expected endotoxin levels. The 318 kits were distributed in the United States and Canada.
Product
Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0729-2025·2025-01-01
O&M Halyard Surgical Masks Recalled for Failing Bioburden Testing
O&M Halyard SOFT TOUCH II Surgical Masks (lot AM4119961) are being recalled for not meeting EN 14683 bioburden testing standards printed on the packaging. No illnesses or injuries have been reported.
Product
O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0761-2025·2025-01-01
EMPOWR 3D Knee Tibial Insert Recalled for Wrong Product in Package
Encore Medical is recalling 9 units of EMPOWR 3D Knee Tibial Insert (Lot 076T1273A) because packages may contain an acetabular system instead of the intended knee insert, potentially causing surgical delays.
Product
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0750-2025·2025-01-01
BYTE Aligner System Recalled for Virtual-Only Approval Workflow Gaps
Straight Smile LLC is recalling BYTE Aligner systems due to a virtual-only clinical workflow that may not adequately screen patients with contraindications for aligner use. Approximately 5.3 million devices are affected.
Product
BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function o
Category
Medical Device
Distribution
Distributed nationwide