State

South Dakota product recalls

73,106 recalls have nationwide distribution and so reach South Dakota. 2,684 additional recalls listed South Dakota specifically in their distribution scope.

What the numbers show

Total: 2,684
Critical: 401
Severe: 567
Most recent: 2026-09-23

Of the 2,684 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 567 (21%) are Severe.

Which agencies issued them

These figures cover only the 2,684 recalls whose distribution notice names South Dakota specifically. The 73,106 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

12151–12175 of 75790

SevereFDA (Drugs)·D-0429-2024·2024-04-03
Treprostinil Injection recalled nationwide due to particulate matter contamination
Par Pharmaceutical is recalling Treprostinil Injection nationwide due to the presence of particulate matter. This FDA Class I recall affects 466 vials of lot 57014 distributed throughout the United States.
Product
Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-206-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1324-2024·2024-04-03
FDA Recalls stay-safe Luer Lock Adapter for Chemical Leachables
The FDA is recalling approximately 828,954 stay-safe Luer Lock Adapters due to chemical leachables identified in the peroxide cross-linked tubing. The nationwide recall affects all lots of Model Number 050-95003.
Product
stay-safe /Luer Lock Adapter 4 in
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1325-2024·2024-04-03
Stay-safe Luer Lock catheter extension recalled for chemical leachables
Fresenius is recalling 663,221 stay-safe Luer Lock catheter extension units nationwide due to chemical leachables (NDL PCBAs) identified in the tubing.
Product
stay-safe /Luer Lock Catheter Ext. 12 in
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1383-2024·2024-04-03
RELAY PRO Thoracic Stent-Graft System recalled for incorrect size
Bolton Medical Inc. is recalling 21 RELAY PRO Thoracic Stent-Graft Systems because the stent-graft inside the delivery system is the incorrect size.
Product
RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28-M4-34-100-34U; (b) Part number 28-M4-30-095-30U; (c) Part number 28-M4-46-155-46U; (d) Part number 28-M4-32-155-32S; (e) Part…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1388-2024·2024-04-03
Epix Universal Clip Applier Recalled for Potential Clip Loading Failure
Applied Medical Resources is recalling the Epix Universal Clip Applier because the device may fail to load the surgical clip after the trigger is actuated. Units were distributed worldwide.
Product
Epix Universal Clip Applier, REF: CA500, STERILEEO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0408-2024·2024-04-03
HYDROmorphone Injectable Recalled Due to Sterility Assurance Failure
SCA Pharmaceuticals is recalling HYDROmorphone HCl injections due to lack of assurance of sterility. Patients who received the affected lot should contact their healthcare provider.
Product
HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17, Bar Code 7004030317
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1358-2024·2024-04-03
Bio-Rad QXDx BCR-ABL diagnostic kit recalled for calibration errors
Bio-Rad Laboratories is recalling a diagnostic test kit due to incorrect calibrations and controls that may produce inaccurate test results. Patients and healthcare providers should contact the manufacturer.
Product
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1395-2024·2024-04-03
Emergency traction splint adhesive failure may compromise device function
Emergency Products & Research is recalling 190,000 O.T.D. traction splints because adhesive may fail to secure the pole insert, potentially compromising function in emergency medical situations.
Product
O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0414-2024·2024-04-03
Phenylephrine HCl Injections Recalled Nationwide for Sterility Assurance Issues
SCA Pharmaceuticals is recalling Phenylephrine HCl injections nationwide affecting approximately 33,000 units due to lack of assurance of sterility.
Product
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-12, Bar Code 70004081012
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1362-2024·2024-04-03
Thermalon Back Wrap Recalled for Potential Mold and Mildew Growth
Certain lots of Thermalon Back Wrap may have been exposed to excessive moisture, potentially resulting in mold and mildew growth. The product is distributed nationwide in the US and Canada.
Product
Thermalon Back Wrap, Item Number 24312
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0423-2024·2024-04-03
Succinylcholine chloride injection recalled for lack of sterility assurance
SCA Pharmaceuticals recalls Succinylcholine Chloride 200 mg/10mL injectable due to lack of assured sterility. The recall affects 8,755 syringes distributed nationwide.
Product
SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-12, Bar Code 70004090812
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0401-2024·2024-04-03
FDA Recalls Fentanyl-Bupivacaine Injection Due to Sterility Assurance Concerns
SCA Pharmaceuticals is recalling 130 cassettes of a fentanyl-bupivacaine epidural injection distributed nationwide due to lack of assurance of sterility.
Product
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0251-64, Bar Code…
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0417-2024·2024-04-03
Injectable Phenylephrine Recall Due to Sterility Assurance Failure
SCA Pharmaceuticals recalled approximately 8,050 syringes of PHENYLephrine HCl injection nationwide due to lack of assured sterility. Affected lots have expiration dates from November 2023 to June 2024.
Product
PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0418-2024·2024-04-03
Phenylephrine HCl Injectable Recalled Nationwide for Lack of Sterility Assurance
SCA Pharmaceuticals is recalling Phenylephrine HCl Injectable (400 mcg/10 mL) distributed nationwide due to lack of sterility assurance. Affected lot numbers have expiration dates through May 2024.
Product
PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0811-12, Bar Code 70004081112.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0397-2024·2024-04-03
Fentanyl-Bupivacaine Epidural Injection Recalled for Sterility Assurance Failure
SCA Pharmaceuticals is recalling 242 bags of fentanyl-bupivacaine epidural injection due to lack of assurance of sterility. The affected lot may not meet required sterility standards.
Product
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-32, Bar Code 70004023132
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1371-2024·2024-04-03
Aptima CMV Quant Assay Recalled for Invalid Results with Plasma Specimens
Hologic is recalling 684 kits of the Aptima CMV Quant Assay diagnostic test; when used with plasma specimens, the assay may generate error codes that invalidate test results. Lot number 402941 is affected.
Product
Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Promoter Reconstruction solution, Target capture Reagent…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0404-2024·2024-04-03
FDA Recalls HYDROmorphone Injection Cassettes Due to Sterility Concerns
SCA Pharmaceuticals recalls 256 units of HYDROmorphone HCl injection in Grey CADD Cassettes nationwide due to lack of assured sterility. The affected lot is #1223049529 with expiration date 01/03/24.
Product
HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-63, Bar Code 70004030063
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1381-2024·2024-04-03
Medivance Neonatal ArcticGel Pads Recalled for Reduced Water Flow
Medivance Inc. is recalling Neonatal ArcticGel Pads due to reduced water flow that may prevent proper heating or cooling performance in neonatal temperature management systems. No injuries have been reported.
Product
Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0412-2024·2024-04-03
Injectable midazolam HCl recalled due to sterility assurance failure
SCA Pharmaceuticals is recalling Midazolam HCl 100 mg/100 mL injectable nationwide because the manufacturer cannot assure sterility of the product. Users should consult their healthcare provider regarding affected lot numbers.
Product
Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0411-59, Bar Code 70004041159
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0413-2024·2024-04-03
Neostigmine methylsulfate injection recalled nationwide due to sterility concerns
SCA Pharmaceuticals is recalling 1,122 syringes of neostigmine methylsulfate injection nationwide due to inability to assure product sterility. The affected lot is 1223048138 (expiration 1/31/24).
Product
neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0750-09, Bar Code 70004075009
Category
Drug
Distribution
Distributed nationwide
HighNHTSA·24V249000·2024-04-03
2023-2024 Aston Martin DBX Oil Cooler Hoses May Burst
Aston Martin is recalling certain 2023-2024 DBX707 vehicles because oil cooler hoses may burst, causing sudden oil loss that could lead to engine failure and fire.
Product
ASTON MARTIN — ASTON MARTIN DBX
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0422-2024·2024-04-03
FDA Recalls Sodium Citrate Injectable Solution Due to Sterility Concerns
SCA Pharmaceuticals recalls Sodium Citrate 4% injectable solution syringes (9,624 units) distributed nationwide due to lack of assurance of sterility.
Product
Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0900-25, Bar Code 70004090025
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0416-2024·2024-04-03
PHENYLephrine Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals recalls PHENYLephrine HCl injectable syringes nationwide due to lack of sterility assurance. The recall affects 1,118 syringes across two lot numbers distributed throughout the USA.
Product
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Code 70004081011. (same finished product as F078140, but with RFID…
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0396-2024·2024-04-03
Fentanyl Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals recalls fentanyl 2,500 mcg injection due to lack of sterility assurance. Affected batches were distributed nationwide.
Product
fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0222-30 BAR code 70004022230
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1359-2024·2024-04-03
Thermalon Eye Compress Recalled Due to Potential Mold and Mildew Growth
Bruder Healthcare Company is recalling Thermalon Eye Compress Item 2434 from certain lots due to potential mold and mildew growth from excessive moisture exposure. Affected products were distributed in the US and Canada.
Product
Thermalon Eye Compress, Item Number 2434
Category
Medical Device
Distribution
Distributed nationwide