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.

7976–8000 of 75667

HighFDA (Devices)·Z-1000-2025·2025-01-29
Olympus Thunderbeat Surgical Instruments Recalled for Damaged Probe Tips
Olympus Corporation is recalling Olympus Thunderbeat surgical hand instruments (Model TB-0545FCS) due to probe tips that are being damaged or breaking, which may affect instrument function during medical procedures.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423510 Software Version: N/A Product Description: Thunderbeat instrument is a s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0982-2025·2025-01-29
Stryker 3.0MM Neuro Precision Head Recalled for Package Labeling Mismatch
Stryker is recalling the 3.0MM Precision Neuro Match Head due to a packaging discrepancy where the device may not match the product label. Approximately 1,489 units distributed worldwide are affected, including lot numbers 22179047, 22179027, and 22160017.
Product
stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0966-2025·2025-01-29
Otological Ventilation Tubes Recalled for Lack of FDA Premarket Clearance
Adept Medical Ltd is recalling Otological Ventilation Tubes (T-Tube 9mm, Silicone) distributed without FDA 510(k) premarket notification clearance. Approximately 6,280 units were distributed in the US and internationally.
Product
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1014-2025·2025-01-29
Dressing Change Kits Recalled for Potential Package Sterility Compromise
Trinity Sterile is recalling Wolf-Pak Dressing Change Kits due to a potential hole in the package that could compromise the sterility of the medical kit. Lot #600022 (3,960 units) distributed nationwide.
Product
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 132 cases affected. Componen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0981-2025·2025-01-29
Stryker neurosurgical device labeling mismatch: wrong instruments shipped
Stryker is recalling 3.0MM Neuro Match Head devices (REF 5820-107-430) where the actual device may not match the product label, potentially causing surgeons to use wrong instruments during neurosurgery.
Product
stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0993-2025·2025-01-29
Olympus Thunderbeat surgical instrument probe tips breaking and detaching
Olympus is recalling Thunderbeat surgical instruments due to probe tip damage, breaking, and pad detachment.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: R5000687 Software Version: N/A Product Description: Thunderbeat instrument is a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1015-2025·2025-01-29
Dressing Change Kit Recalled Due to Package Integrity Concern
Trinity Sterile is recalling Wolf-Pak Premium Dressing Change Kits due to potential holes in packaging that could compromise sterility. The recall affects 5,940 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.
Product
Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600088, 198 cases affected. Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0206-2025·2025-01-29
First Aid Beauty Ultra Repair Cream Recalled for CGMP Deviations
First Aid Beauty is recalling Ultra Repair Cream due to CGMP (Current Good Manufacturing Practice) deviations. Product intended for quarantine was inadvertently distributed nationwide.
Product
First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1003-2025·2025-01-29
Olympus Thunderbeat Surgical Instruments Recalled for Probe Tip Damage
Olympus is recalling Thunderbeat hand instruments (Model TB-0535FCS) because probe tips can be damaged or break during use. The recall affects 27,352 units distributed internationally.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat, 5MM, 35CM, Front-actuated Grip Type S¿ Model Number: TB-0535FCS Catalog Number/Product Code: N5423810 Software Version: N/A Product Description: Thunderbeat instrument is a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0963-2025·2025-01-29
Otological Ventilation Tubes Recalled for Missing FDA 510(k) Clearance
Adept Medical Ltd is recalling 13,070 Otological Ventilation Tubes because they were distributed without FDA 510(k) clearance. Over 9,000 units were distributed in the US and 3,980 internationally.
Product
Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0985-2025·2025-01-29
Medtronic Recalls EOPA Arterial Cannula Models for Labeling Errors
Medtronic Perfusion Systems is recalling EOPA Arterial Cannula models 77418 and 77422 due to incorrect labeling on seven manufacturing lots. Approximately 930 units were distributed worldwide.
Product
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0989-2025·2025-01-29
CardioMEMS Heart Failure Monitoring System Cloud Migration Causes Inaccurate Pressure Readings
St. Jude Medical recalled 431 CardioMEMS HF pressure measurement systems after a cloud data migration reverted systems to outdated configuration, causing inaccurate pulmonary artery pressure readings.
Product
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1018-2025·2025-01-29
Randox Lipoprotein (a) Diagnostic Assay Lacks FDA Clearance, Recalled
Randox Laboratories is recalling 33 Randox Lipoprotein (a) diagnostic kits nationwide. The assay's claims for use on Roche Cobas c501 analyzers lack required FDA clearance or approval.
Product
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1001-2025·2025-01-29
Olympus Thunderbeat Hand Instruments Recalled for Probe Tip Damage and Breaking
Olympus is recalling Thunderbeat hand instruments because probe tips can be damaged or break, and pads can detach during use. No injuries have been reported.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5423930 Software Version: N/A Product Description: Thunderbeat instrument is a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0997-2025·2025-01-29
Olympus Thunderbeat Surgical Hand Instruments Recalled for Damaged Probe Tips
Olympus recalls 54,500 Thunderbeat surgical hand instruments due to probe tips that may be damaged or break. These sterile devices are used in ultrasonic surgical procedures.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm ,Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423630 Software Version: N/A Product Description: Thunderbeat instrument is a s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0988-2025·2025-01-29
CardioMEMS HF Pressure Measurement System Recalled for Inaccurate Readings
St. Jude Medical is recalling the CardioMEMS HF Pressure Measurement System due to a cloud data migration that caused the system to revert to an outdated configuration, resulting in inaccurate pulmonary artery pressure readings.
Product
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1010-2025·2025-01-29
Baxter Clearlink system solution sets recalled for clamp defect
Baxter Healthcare is recalling specific lots of Clearlink System Solution Sets with inverted clamps that render the tubing unusable. The affected units are distributed nationwide in eight U.S. states.
Product
Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0998-2025·2025-01-29
Olympus Thunderbeat Surgical Instrument Recalled for Damaged or Breaking Probe Tips
Olympus is recalling approximately 9,200 units of Thunderbeat surgical hand instruments distributed worldwide because probe tips can become damaged, break, or pads can detach during use.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423330 Software Version: N/A Product Description: Thunderbeat instrument is a s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0996-2025·2025-01-29
Olympus Thunderbeat Surgical Hand Instruments Recalled for Probe Damage
Olympus Corporation is recalling Olympus Thunderbeat front-actuated surgical hand instruments (Model TB-0535FCS) due to damaged or breaking probe tips and pad detachment. Approximately 128,608 units distributed outside the US are affected.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423730 Software Version: N/A Product Description: Thunderbeat instrument is a
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0986-2025·2025-01-29
Medtronic Arterial Cannula Recall Due to Incorrect Labeling
Medtronic Perfusion Systems is recalling Select Series Angled Tip Arterial Cannulas (Model 72422) due to incorrect labeling. The recall involves 440 units distributed nationwide.
Product
Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0968-2025·2025-01-29
Otological Ventilation Tubes recalled due to lack of FDA 510(k) clearance
Adept Medical Ltd is recalling 310 units of Otological Ventilation Tubes (Product Code NZ3312-2) distributed in the US and internationally due to lack of FDA 510(k) regulatory clearance. The devices were distributed without required FDA pre-market approval.
Product
Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0984-2025·2025-01-29
Medtronic Pediatric Arterial Cannulae Recalled for Incorrect Labeling
Medtronic is recalling 745 DLP Pediatric Arterial Cannulae (Models 77008 and 77014) due to incorrect labeling affecting seven manufactured lots distributed nationwide and worldwide.
Product
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0980-2025·2025-01-29
Stryker Surgical Burs Recalled Due to Package Label Mismatch
Stryker Corporation is recalling surgical burs that may be packaged with incorrect labels, causing a mismatch between the device model inside and the label. Approximately 491 affected devices were distributed worldwide.
Product
The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/ Otorhinolaryngology, orthopedic, and general surgic
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0205-2025·2025-01-29
Kissable Diabetics Foot Cream recalled nationwide for inadequate release testing
Brands International Corporation is recalling Kissable Diabetics Foot Cream nationwide due to lack of adequate release testing during manufacturing. The FDA has classified this as a Class II recall.
Product
Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0965-2025·2025-01-29
Otological Ventilation Tubes Recalled for Lack of FDA Premarket Clearance
Adept Medical Ltd is recalling 2,610 T-Tube 9mm otological ventilation tubes distributed without required FDA premarket 510(k) clearance. The affected silicone tubes were sold in the US and internationally.
Product
Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
Category
Medical Device
Distribution
Distributed nationwide