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.

9176–9200 of 75673

HighFDA (Devices)·Z-0077-2025·2024-10-30
Datex-Ohmeda Aespire View Anesthesia Machines Recalled for Connection Error Risk
Datex-Ohmeda is recalling 10,338 Aespire View anesthesia machines due to a potential issue where a patient breathing circuit limb may be mistakenly connected to the Auxiliary Common Gas Outlet port.
Product
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0084-2025·2024-10-30
Datex-Ohmeda Auxiliary Common Gas Outlet Conversion Kits Recalled
Datex-Ohmeda is recalling 649 Auxiliary Common Gas Outlet (ACGO) conversion kits due to a potential issue if a patient breathing circuit limb is mistakenly connected to the ACGO port.
Product
Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due to being purchased with or later used to convert to ACGO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0224-2025·2024-10-30
Quantum Perfusion Systems CPB Roller Pumps Recalled for Mechanical Locking Defect
Spectrum Medical Ltd. is recalling 172 Quantum Perfusion Systems CPB Roller Pumps due to an out-of-tolerance ratchet and pawl defect preventing proper bobbin locking. This defect may affect blood circulation control during cardiac surgery.
Product
Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0175-2025·2024-10-30
Medline medical procedure kits recalled due to potential non-sterile product risk
Medline is recalling four types of medical procedure convenience kits that may contain non-sterile products if the pouch seal is opened. Approximately 197 units were distributed nationwide and internationally.
Product
Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B; c) GYN ANCILARY PACK, REF DYNJ84509; d) GYN LITHOTOMY MINOR, REF DYNJ907707
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0155-2025·2024-10-30
Medline Medical Procedure Kits Recalled for Potential Non-Sterile Product
Medline brand medical procedure convenience kits are recalled because their packaging may allow product sterility to be compromised. The affected units were packaged in breather pouch lot 323080002.
Product
Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH PACK-LF, REF DYNJ19010I; c) SUPPLEMENTAL NEURO ANGIO PK, REF DYNJ29207; d) ANGIO PACK, REF DYNJ43661C; e) LEFT HEART CATH TEGH-LF, REF DYNJ46746C; f) L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0016-2025·2024-10-30
Phenylephrine Injection Recalled Due to Manufacturing Quality Violations
Fresenius Kabi Compounding recalled phenylephrine HCl injectable due to cGMP violations. The recall affects 2,756 doses distributed to 125 direct accounts nationwide.
Product
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0169-2025·2024-10-30
Medline Pediatric Drape Kit Recalled Due to Potential Non-Sterile Product Risk
Medline recalled pediatric drape kits that may become non-sterile if the pouch seal is compromised. Affected units were distributed in the US, Canada, and Panama.
Product
Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0022-2025·2024-10-30
FDA recalls epinephrine injection for manufacturing compliance violations
Fresenius Kabi Compounding recalled epinephrine 0.9% sodium chloride injections due to current good manufacturing practice violations. The recall affecting 753 bags distributed to 125 healthcare accounts was terminated on August 15, 2025.
Product
EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0148-2025·2024-10-30
Medline Centurion Tracheostomy Kit Recalled Due to Non-Sterility Risk
Medline is recalling certain Centurion tracheostomy kits due to potential non-sterility if the packaging seal is compromised. The affected kits may allow non-sterile product use.
Product
Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0152-2025·2024-10-30
Medline CV Anesthesia Room Setup Kits Recalled for Sterility Risk
Medline is recalling 15 CV Anesthesia Room Setup kits because a packaging defect may allow non-sterile product use if the pouch seal is opened.
Product
Medline CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0024-2025·2024-10-30
Dietary supplement tablets recalled for undeclared diclofenac and acetaminophen
AK Forte Ortiga y Omega 3 tablets are recalled nationwide for containing undeclared diclofenac and acetaminophen without FDA approval. Consumers should stop using this product immediately.
Product
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0161-2025·2024-10-30
Medline medical procedure kits recalled for potential sterility breach
Medline medical procedure convenience kits with certain breather pouches may lose sterility if the vendor seal is opened. Approximately 5,972 units were distributed in the US, Canada, and Panama.
Product
Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF DYNJ25834B; 4) CYSTO PACK, REF DYNJ35569C; 5) PAVILION MINOR PACK, REF DYNJ40724D; 6) CYSTOSCOPY PACK, REF DYNJ41105C; 7)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0178-2025·2024-10-30
Medline Medical Procedure Convenience Kits Recalled for Potential Non-Sterility Risk
Medline is recalling certain medical procedure convenience kits due to a breather pouch seal defect. If the pouch seal is opened or compromised, the product may not be sterile and could pose a health risk during surgical use.
Product
Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ22354L; 3) EYE PACK, REF DYNJ24573K; 4) EYE PACK, REF DYNJ30327A; 5) BASIC CATARACT PACK, REF DYNJ36868F; 6) BASIC RETINA PACK, REF DYNJ40811A; 7) OPHTHALMOLO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0167-2025·2024-10-30
Medline chest tube insertion tray may contain non-sterile equipment due to breached seal
Medline is recalling certain chest tube insertion trays due to potential sterility loss if the vendor seal is breached. Non-sterile equipment poses a serious risk during invasive medical procedures.
Product
Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0179-2025·2024-10-30
Medline medical procedure kits recalled due to potential non-sterile packaging
Medline is recalling 2,371 medical procedure convenience kits because certain kits packaged in specific breather pouches may contain non-sterile product if the seal is compromised.
Product
Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CDS984003A; 3) SPECIAL PROCEDURE PACK, REF DYNJ32639C; 4) PK-ORTHO-MINOR, REF DYNJ39547B; 5) ANT CERV ADD ON PACK, REF DYNJ41229C; 6) NAV
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0021-2025·2024-10-30
Oxytocin Injection Recalled for Current Good Manufacturing Practice Violations
Fresenius Kabi Compounding is voluntarily recalling over 4,400 bags of Oxytocin 0.9% Sodium Chloride Injection due to current Good Manufacturing Practice violations. No illnesses have been reported.
Product
Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0015-2025·2024-10-30
Sterile drug injection bags recalled for manufacturing process violations
Fresenius Kabi Compounding recalled 1,631 bags of Phenylephrine HCl injection due to manufacturing process violations. The product was distributed to 125 healthcare facilities nationwide. The recall was concluded in August 2025.
Product
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0025-2025·2024-10-30
Stool Softener Laxative Recalled Due to Manufacturing Practice Deviations
Akron Pharma is recalling OneLAX Docusate Sodium Liquid stool softener due to manufacturing practice deviations. The recall affects 10,845 bottles distributed nationwide.
Product
OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0014-2025·2024-10-30
Drug injection product recalled due to manufacturing quality violations
Fresenius Kabi Compounding is recalling phenylephrine HCl injection bags due to manufacturing quality violations. The recall affects 1,313 bags distributed to 125 healthcare accounts.
Product
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0181-2025·2024-10-30
Olympus Gastrointestinal Videoscope Recalled Due to Incorrect Sensor Color Correction Programming
Olympus Corporation is recalling the Gastrointestinal Videoscope Model GIF-1100 due to incorrect color correction data programmed into CCD imaging sensors. The affected units do not meet device specifications.
Product
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0138-2025·2024-10-30
Quantimetrix Urine Chemistry Control Set Recalled for Temperature Exposure
Mckesson Medical-Surgical is recalling Quantimetrix Urine Chemistry Control Sets shipped without validated summer packaging, potentially exposing them to temperatures above 25°C.
Product
Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed test methods.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0209-2025·2024-10-30
Blue Ortho Recalls Predict+ Software for Lack of FDA Clearance
Blue Ortho is recalling 136 units of Predict+ software because it lacks FDA pre-market clearance or approval.
Product
Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0207-2025·2024-10-30
Diasol Acid Concentrate Recalled for Labeling Discrepancy
Diasol, Inc. is recalling 852 gallon bottles of Diasol Acid Concentrate because the gallon label shows a lower calcium concentration than the box label.
Product
Diasol Acid Concentrate REF G100325-10Dex 100
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0018-2025·2024-10-30
Vancomycin Injection Recalled Due to Manufacturing Process Violations
Fresenius Kabi Compounding is recalling Vancomycin HCl injectable medication due to cGMP manufacturing violations. The recall affects 1,082 bags distributed to 125 healthcare accounts nationwide.
Product
Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0019-2025·2024-10-30
Drug Recall: NORepinephrine Injectable Due to Manufacturing Compliance Violations
Fresenius Kabi Compounding recalls 2,151 bags of NORepinephrine Bitartrate injectable due to manufacturing violations. The voluntary recall affects 125 healthcare accounts nationwide.
Product
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58
Category
Drug
Distribution
Distributed nationwide