State

South Dakota product recalls

72,966 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 72,966 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

5626–5650 of 75647

CriticalFDA (Devices)·Z-2273-2025·2025-08-20
Carotid stent delivery systems recalled over resistance during withdrawal after deployment
Certain batches of the Carotid WALLSTENT Monorail Endoprosthesis are being removed after complaints of greater than anticipated resistance withdrawing the delivery system. The most serious potential consequence is stroke.
Product
Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 CAROTID WALLSTENT MONORAIL 10.0-24; H7493915010310 CAROTID WALLSTENT MONORAIL 10.0-31; H749391506220 CAROTID WALLSTENT MONORAIL
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2181-2025·2025-08-20
Manual resuscitators recalled because blocked manometer port may disable pressure gauge
Ambu is recalling 87,156 SPUR II adult resuscitators because the manometer port may be blocked, leaving the manometer non-functional. The FDA classified the action as Class I.
Product
Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611057 4
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2290-2025·2025-08-20
HeartMate mobile power unit cords recalled over locking feature that may disconnect
Abbott is recalling 53 HeartMate Mobile Power Unit AC power cords, model 107760, because a misaligned V-Lock may not engage and can allow an unintended disconnect. The FDA classified this as Class I.
Product
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device desi
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2229-2025·2025-08-20
Non-continuous ventilators recalled over programming error causing incorrect device configuration
DreamStation Auto non-continuous ventilators are recalled because the devices may carry a programming error resulting in an incorrect device configuration. The FDA classified the action as Class I.
Product
DreamStation Auto. Non-Continuous Ventilator.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2173-2025·2025-08-20
Infusion pumps recalled over underinfusion when flow rate more than doubles
Baxter is issuing an urgent correction for 36,705 Novum IQ large volume pumps because the pump may underinfuse when moving to a flow rate more than double the current one.
Product
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·25V532000·2025-08-20
Aston Martin Recalls 2025 Vanquish for Brake Assist Software Defect
Aston Martin is recalling 2025 Vanquish vehicles because a vacuum pump defect may cause loss of power brake assist, increasing stopping distance and crash risk.
Product
ASTON MARTIN — ASTON MARTIN VANQUISH
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2291-2025·2025-08-20
HeartMate mobile power unit cords may disconnect from a misaligned lock
HeartMate Mobile Power Units are being recalled because misaligned V-Lock features on the power cords prevent the locking mechanism engaging properly and may cause unintended disconnect. 604 units affected.
Product
Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2228-2025·2025-08-20
DreamStation Auto BiPAP units may hold an incorrect device configuration
DreamStation Auto BiPAP non-continuous ventilators are being recalled because the devices may possess a programming error resulting in an incorrect device configuration. 8 units are affected.
Product
DreamStation Auto BiPAP. Non-Continuous Ventilator.
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·25V533000·2025-08-20
Mercedes steering coupling bolt may loosen from the steering rack
Mercedes-Benz is recalling certain 2023-2026 EQE and GLC vehicles because the steering coupling bolt may have been improperly tightened, allowing the coupling to loosen from the steering rack.
Product
MERCEDES-BENZ — MERCEDES-BENZ EQE 500 4MATIC, EQE 350 4MATIC, GLC 350 E 4MATIC, GLC 300 4MATIC
Category
Vehicle
Distribution
Distributed nationwide
SevereUSDA FSIS·028-2025·2025-08-20
Sabrositos Hondurenos Recalls Meat Products Produced Without Federal Inspection
Sabrositos Hondurenos, LLC is recalling approximately 32,000 pounds of meat products that were produced without federal inspection and bear false USDA marks.
Product
Sabrositos Hondurenos, LLC, Recalls Various Meat Products Produced Without Benefit of Inspection
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2227-2025·2025-08-20
DreamStation Auto CPAP units may hold an incorrect device configuration
DreamStation Auto CPAP non-continuous ventilators are being recalled because the devices may possess a programming error resulting in an incorrect device configuration. 57 units are affected.
Product
DreamStation Auto CPAP. Non-Continuous Ventilator.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0470-2025·2025-08-20
Helados Mexico choco dipped paletas list cream without declaring milk
Helados Mexico Choco Dipped Minis Variety Paletas 12-count are being recalled because the label includes the ingredient cream but does not include milk as the source. 70,044 units affected.
Product
Helados Mexico Choco Dipped Minis Variety Paletas 12-Count 18oz UPC: 6-82082-41215-7
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2297-2025·2025-08-20
3mensio workstation clock measurements may place stent graft fenestrations incorrectly
3mensio Workstation (Vascular Fenestrated) software is being recalled because changing the 12h position of a single clock does not update other clock measurements, which may place stent graft fenestrations incorrectly. 501 units affected.
Product
3mensio Workstation (Vascular Fenestrated) software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2295-2025·2025-08-20
Custom manifold kit tubing may separate and trap air in line
Custom Manifold Kits are being recalled because high pressure tubing may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 6,327 units affected.
Product
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2284-2025·2025-08-20
Kittner roll gauze with tail recalled over contamination and incorrect pack quantity
Carefree Surgical Specialties Kittner Roll Gauze + Tail, catalog 15506/25 lot 1607, is recalled for biological foreign matter that could compromise sterility and for incorrect gauze counts. 65 units are affected.
Product
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15506/25 Product Description: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2280-2025·2025-08-20
Cannulated fenestrated polyaxial screws recalled because they may be incorrectly labeled
PERLA TL MIS cannulated fenestrated polyaxial screws, model MPF-PS 55 45-S, lot 8-4266, are recalled because the screws may be incorrectly labeled.
Product
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2286-2025·2025-08-20
EMPOWR 3D knee tibial inserts recalled over incorrect size or side labeling
Enovis is recalling 40 EMPOWR 3D Knee tibial inserts, catalog number 342-16-707, because the implants carry incorrect size or side labeling.
Product
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2287-2025·2025-08-20
Neurostimulator patient controllers recalled over cable disconnect errors interrupting stimulation output
Sparrow Ascent Patient Controllers are recalled because a manufacturing issue may produce a cable disconnect error message and interrupt stimulation output. 78 units are affected.
Product
Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2322-2025·2025-08-20
Thyroglobulin assay reagent recalled after lot generated erroneously high patient results
Access Thyroglobulin assay reagent lot 439163 is recalled because it may generate erroneously high patient results, which could prompt unnecessary imaging or therapy changes. 453 units are affected.
Product
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0578-2025·2025-08-20
Carvedilol 12.5 mg tablets recalled over nitrosamine above acceptable intake level
Glenmark Carvedilol Tablets USP, 12.5 mg, lot 19243202, are recalled nationwide because N-Nitroso Carvedilol I impurity was found above the current Acceptable Intake level. 6,432 bottles are affected.
Product
CARVEDILOL — CARVEDILOL (CARVEDILOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0577-2025·2025-08-20
Carvedilol 3.125 mg tablets recalled for nitrosamine impurity above intake limit
Glenmark Carvedilol Tablets USP, 3.125 mg, in 100- and 500-count bottles are recalled nationwide because N-Nitroso Carvedilol I impurity exceeded the current Acceptable Intake level. 44,328 bottles are affected.
Product
CARVEDILOL — CARVEDILOL (CARVEDILOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·H-0461-2025·2025-08-20
Bubble gum paletas recalled because label lists cream without naming milk
La Michoacana Bubble Gum Single Serve Paletas, 3.75 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 12,163 units are affected.
Product
La Michoacana Bubble Gum Single Serve Paleta 3.75oz UPC: 7-67778-00003-7
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2293-2025·2025-08-20
High pressure tubing may separate and trap air in the line
High Pressure Tubing is being recalled because it may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 8,040 units affected.
Product
High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0467-2025·2025-08-20
Rompope bolis 6-count packs recalled over cream ingredient missing milk source
La Michoacana Rompope Bolis 6-Count 24 oz packs are recalled nationwide because the label lists cream but does not declare milk as its source. 11,274 units are affected.
Product
La Michoacana Rompope Bolis 6-Count 24oz UPC:7-67778-05004-9
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·H-0466-2025·2025-08-20
Variety paleta 16-count packs recalled over cream ingredient missing milk source
La Michoacana Variety Paletas, 16-count 44 oz packs, are recalled nationwide because the label lists cream but does not declare milk as its source. 2,241 units are affected.
Product
La Michoacana Variety Paletas 16-Count 44oz UPC:7-67778-03100-0
Category
Food
Distribution
Distributed nationwide