State

South Dakota product recalls

72,936 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 72,936 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3076–3100 of 75617

HighFDA (Devices)·Z-1401-2026·2026-02-25
Line insertion kits recalled over sterilization equipment calibration issues
Medline is recalling 553 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 4) NICU LINE CHANGE TRAY, Model Number: LC295; 5) OSC SHERMAN KNEE ARTHRO BASIC, M
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1424-2026·2026-02-25
Surgical gowns recalled over sterilization equipment calibration issues
Medline is recalling 70,376,042 units of surgical gowns because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 2) GOWN,SIRUS,NONRNF,SETINSLV,L,20/CS, Model Number: DYNJP2001S; 3) GOWN,ECLIPSE,NONRNF,XL,ST,30/CS, Model Number: DYNJP2002; 4) GOWN,SIRUS,NONRNF,SETINSLV,XL,20/CS, Model Number: DYNJP2002S; 5) GOW
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1426-2026·2026-02-25
Cervical disc implants recalled after 5mm product was labeled 6mm
Centinel Spine is recalling 20 Prodisc C SK total cervical disc replacements because products were mislabeled as the 6mm product but included the 5mm product.
Product
Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1408-2026·2026-02-25
PPE kits recalled over sterilization equipment calibration issues
Medline is recalling 7,575 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1388-2026·2026-02-25
Endoscopy and angiography kits recalled over sterilization calibration issues
Medline is recalling 3,561 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0800934D; 3) GENERAL ENDO PACK-LF, Model Number: DYNJ0842873J; 4) OR ANGIO PACK-LF, Model Number: DYNJ43415C; 5) ANGIO PACK II, Model Number: DYNJ44066
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·26C002000·2026-02-25
Evenflo Recalls LiteMax Child Seats Due to Incorrect Spanish Manual
Evenflo is recalling LiteMax Factory Select child seats because the Spanish manual lists incorrect weight and height limits, which could lead to improper restraint.
Product
EQUIPMENT:OTHER:OWNERS/SERVICE/OTHER MANUAL recall
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1378-2026·2026-02-25
Olympus Thunderbeat Pistol Grip Medical Device Recalled Due to Adverse Events
Olympus Corporation of the Americas is removing Olympus Thunderbeat 5mm, 35 cm, Pistol Grip devices due to reports of adverse events.
Product
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1411-2026·2026-02-25
LVAD driveline trays recalled over sterilization equipment calibration issues
Medline is recalling 9,720 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1405-2026·2026-02-25
General closure kits recalled over sterilization equipment calibration issues
Medline is recalling 108 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1410-2026·2026-02-25
Admit kits recalled over sterilization equipment calibration issues
Medline is recalling 1,070 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1372-2026·2026-02-25
Olympus Thunderbeat 5 mm 35 cm Surgical Device Recalled Due to Adverse Events
Olympus Corporation of the Americas is removing Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip Type S devices due to reports of adverse events.
Product
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1398-2026·2026-02-25
Lithotomy packs recalled over sterilization equipment calibration issues
Medline is recalling 808 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1402-2026·2026-02-25
Driveline and central venous kits recalled over sterilization calibration issues
Medline is recalling 684 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1367-2026·2026-02-25
Catheter cutdown trays recalled over damage to the outer tray
Bard Peripheral Vascular is recalling 14,935 Broviac 4.2 Fr single-lumen CV catheter cutdown trays because damage to the outer tray can potentially compromise the sterile barrier.
Product
Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1422-2026·2026-02-25
Arthroscopy kits recalled over sterilization equipment calibration issues
Medline is recalling 175 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501G; 3) ARTHROSCOPY PACK, Model Number: DYNJ32715F; 4) CHS ARTHROSCOPY PACK, Model Number: DYNJ50834C; 5) ARTHROSCOPY TRAY-LF, Model Number: DYNJ51069
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1390-2026·2026-02-25
Medline Cardiac Surgical Convenience Kits Recalled Due to Sterility Calibration Issues
Medline Industries is recalling cardiac surgical convenience kits due to sterilization equipment calibration issues that could affect device sterility assurance levels.
Product
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; 3) OFF PUMP CABG CDS, Model Number: CDS840087AI; 4) OFF PUMP CABG CDS, Model Number: CDS840087AK; 5) OFF PUMP CABG CDS, Model Number: CDS840087AL; 6) OP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1383-2026·2026-02-25
Bronchoscopy robots recalled over arms that may move toward patient-left
Auris Health is recalling 173 MONARCH Platform bronchoscopy systems because a software restart can re-initialize the system to patient-left, leading to unanticipated robotic arm positioning.
Product
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1406-2026·2026-02-25
Choice drape packs recalled over sterilization equipment calibration issues
Medline is recalling 72 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1413-2026·2026-02-25
Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues
Medline Industries, LP is recalling various Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the products.
Product
Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138; 4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142; 5) KIT NEURO FUS LUM P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1396-2026·2026-02-25
GI endoscopy kits recalled over sterilization equipment calibration issues
Medline is recalling 23,238 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1427-2026·2026-02-25
Stryker MOLLI 2 System Recall: Marker Dislodgement Risk
Stryker is recalling the MOLLI 2 System due to magnetized surgical tools that may dislodge markers during target tissue removal procedures. The recall affects 5,864 units distributed worldwide.
Product
MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 008500241951
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1407-2026·2026-02-25
Triple lumen insertion kits recalled over sterilization calibration issues
Medline is recalling 15 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1366-2026·2026-02-25
Medline Industries IV Administration and Extension Sets Recalled Due to Potential Leaks
Medline Industries, LP is recalling various IV administration and extension sets because male luer connectors may leak, crack, or break during use.
Product
Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516; 4) DBD-IV ADMIN SE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1425-2026·2026-02-25
Universal and shoulder packs recalled over sterilization calibration issues
Medline is recalling 193,157 units of surgical packs because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CSModel Number: DYNJP8401
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1423-2026·2026-02-25
Surgical drapes recalled over sterilization equipment calibration issues
Medline is recalling 14,927,765 units of surgical drapes because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: DYNJP2411; 3) SHEET,DRAPE, 40X70,STERILE, Model Number: DYNJP2412; 4) DRAPE,MEDIUM,TAPE,40X70",ST,50/CS, Model Number: DYNJP2412T; 5) SHE
Category
Medical Device
Distribution
Distributed nationwide