The Recall Desk

State

South Dakota product recalls

73,213 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 73,213 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

16001–16025 of 75897

  • SevereFDA (Devices)·Z-1649-2023·2023-06-14

    Philips Respironics Ventilators Recalled for Flow Sensor Debris Accumulation

    Philips Respironics recalled approximately 57,395 ventilators due to environmental debris potentially accumulating on the flow sensor, which may prevent accurate delivery of pressure and volume to patients, risking hypoxemia.

    Product
    Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, DE2110X13B, BL2110X15B, GB2110X15B, EU2110X15B…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1630-2023·2023-06-14

    StealthStation Cranial Software Depth Gauge Synchronization Failure Risk

    A software anomaly in StealthStation Cranial Software causes depth gauge displays to lose synchronization during cranial biopsy procedures, risking inaccurate surgical guidance and tissue injury.

    Product
    StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1651-2023·2023-06-14

    Trilogy Evo O2 EV300 respiratory devices recalled for debris accumulation

    Philips Respironics recalled 18,855 Trilogy Evo O2 EV300 devices because environmental debris may accumulate on the flow sensor, potentially causing inaccurate delivery of pressure or flow. This could result in patient hypoxemia if not promptly addressed.

    Product
    Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V427000·2023-06-14

    Great Dane Recalls 2024 Trailers Due to Tire Pressure Loss Risk

    Great Dane is recalling 2024 Champion and Everest trailers because tire pressure may drop at speeds over 45 mph, increasing crash risk.

    Product
    GREAT DANE — GREAT DANE EVEREST, CHAMPION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1652-2023·2023-06-14

    Trilogy Evo Universal Ventilator Class I Recall—22,237 Units Affected

    The FDA has issued a Class I recall for the Trilogy Evo Universal Ventilator Model DS2000X11B, affecting 22,237 units distributed nationwide and globally. The device is manufactured by Philips Respironics, Inc.

    Product
    Trilogy Evo Universal Ventilator, Model Number DS2000X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0867-2023·2023-06-14

    Eye Drops Recalled: Travoprost Missing Tamper Evidence Seal

    Golden State Medical Supply is recalling Travoprost eye drops due to missing tamper evidence seals on some bottles. The missing seal prevents sterility assurance on 1,920 units distributed nationwide.

    Product
    TRAVOPROST — TRAVOPROST (TRAVOPROST)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1687-2023·2023-06-14

    Avanos Medical Recalls ambIT Reusable Cassettes Missing Air-Inline Filter

    Avanos Medical is recalling SMMT ambIT Reusable cassettes (Product Code 220568, Lot 30191805) that were potentially distributed without a required air-in-line filter. The missing component affects units in Texas, Oregon, and Australia.

    Product
    SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1676-2023·2023-06-14

    Diagnostic Test Recall: 4Kscore Test Software Anomalies May Produce Erroneous Results

    BioReference Health is recalling the 4Kscore Test system due to software anomalies in its processing module that may generate erroneous diagnostic results. The recall affects 662 patient test results distributed in New Jersey.

    Product
    The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1683-2023·2023-06-14

    QIAstat-Dx Respiratory SARS-CoV-2 Test Kit Recalled for False Result Risk

    Qiagen Sciences LLC recalls 347 QIAstat-Dx Respiratory SARS-CoV-2 test kits due to faulty cartridges that could produce false results. Affected kits were distributed nationwide in nine states.

    Product
    QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1675-2023·2023-06-14

    Elekta Unity Image-Guided Radiation Therapy System Electrical Connector Overheating Risk

    Elekta, Inc. is recalling 18 Elekta Unity Image-Guided Radiation Therapy Systems due to a potential electrical connector overheat hazard in the MR gradient coil. No injuries have been reported.

    Product
    Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1684-2023·2023-06-14

    AVNS ambIT Catheter System Kits Recalled for Missing Air Filter

    Avanos Medical recalls some AVNS ambIT System catheter kits that were potentially distributed without an air in-line filter. Affected units were distributed worldwide, including in Texas, Oregon, and Australia.

    Product
    AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1680-2023·2023-06-14

    DePuy Mitek surgical anchor inserter may fracture during use

    DePuy Mitek BIOKNOTLESS Rapid surgical anchor inserters may fracture during use, potentially retaining fragments in patients. Removal during surgery may cause bone damage and extended surgical time.

    Product
    DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1688-2023·2023-06-14

    Avanos Recalls ambIT Cassette Filters for Missing Air In-Line Filter

    Avanos Medical is recalling ambIT Cassette Filter Male Luer (Product Code 220266) because some units were potentially distributed without an air in-line filter component.

    Product
    ambIT Cassette Filter Male Luer, Product Code: 220266
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1681-2023·2023-06-14

    Surgical anchor inserter recalled for potential tip fracture and bone damage

    DePuy Mitek BIOKNOTLESS Rapid anchor inserters may fracture during use, potentially leaving fragments in the patient. If detected during surgery, removal could cause bone damage.

    Product
    DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1677-2023·2023-06-14

    Surgical Anchor Inserter Tip Fragmentation During Patient Procedures

    DePuy Mitek's BIOKNOTLESS Plus anchor inserter may fragment during surgical use if bending force is applied. Fragments retained in the patient may require surgical removal, potentially causing bone damage.

    Product
    DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1685-2023·2023-06-14

    AVNS ambIT System infusion kits recalled for missing air filter

    Avanos Medical is recalling certain AVNS ambIT System infusion kits because some units may lack the required air in-line filter. Affected kits were distributed worldwide including the US (Texas and Oregon) and Australia.

    Product
    AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1679-2023·2023-06-14

    DePuy Mitek surgical anchor inserter tip may fragment and be retained

    DePuy Mitek BIOKNOTLESS Plus surgical anchor inserters may have tips that break off during use and remain in the patient. This could require surgical removal that may cause bone damage.

    Product
    DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1678-2023·2023-06-14

    DePuy Mitek BIOKNOTLESS Plus Anchor Inserter Tip May Fracture During Surgery

    DePuy Mitek BIOKNOTLESS Plus anchor inserter tips may break and be retained in patients during surgery. Removal of fragments could cause bone damage and prolong surgery time.

    Product
    DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1691-2023·2023-06-14

    Sterile Surgical Procedure Packs Recalled for Defective Light Handle Covers

    DeRoyal Industries is recalling 2,972 sterile surgical procedure packs containing light handle covers that have been recalled by another manufacturer. The affected packs were distributed to hospitals in Virginia.

    Product
    Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital; (4) 89-10517.04, CNRV BASIC SETUP PACK, New River…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1689-2023·2023-06-14

    TREO Abdominal Stent-Graft Label Does Not Match Actual Device Size

    Bolton Medical is recalling the TREO Abdominal Stent-Graft System because the carton label may not match the actual stent-graft size inside. Implanting the wrong size stent-graft could result in surgical complications.

    Product
    The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-Graft. Each stent-graft is preloaded into its own delivery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0865-2023·2023-06-14

    Empower Pharmacy Ascorbic Acid Injection Mislabeled as Preserved

    Empower Pharmacy is recalling Ascorbic Acid 500 mg/mL injection solution because vials labeled as preserved are actually preservative-free. The 504 affected vials were distributed nationwide.

    Product
    ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower Pharmacy, 5980 W Sam Houston Pkwy N Ste 300 Houston, TX 77041, NDC 72627-2405-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1682-2023·2023-06-14

    BD Veritor System Instructions for Use Not FDA Approved

    The Instructions for Use for BD Veritor System rapid diagnostic tests for COVID-19 and flu were not FDA-approved, lacking proper specimen type specifications. Using the test with invalid specimen types could produce false positive or negative results, potentially delaying diagnosis or treatment.

    Product
    BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and influenza A and/or B Catalog Number: 256088
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1686-2023·2023-06-14

    SMMT ambIT Kit Basic Filter Luer Cass Recalled for Missing In-Line Filter

    Avanos Medical recalls SMMT ambIT Kit Basic Filter Luer Cass units that were distributed without the required air in-line filter component.

    Product
    SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1692-2023·2023-06-14

    Surgical Procedure Packs Recalled Due to Included Light Handle Covers

    DeRoyal Industries is recalling two models of custom surgical procedure packs because they contain light handle covers that were previously recalled by another manufacturer. The packs were distributed in Virginia.

    Product
    Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.
    Category
    Medical Device
    Distribution
    Distributed nationwide