State

Minnesota product recalls

73,096 recalls have nationwide distribution and so reach Minnesota. 7,838 additional recalls listed Minnesota specifically in their distribution scope.

What the numbers show

Total: 7,838
Critical: 1,139
Severe: 1,904
Most recent: 2026-09-23

Of the 7,838 recalls naming Minnesota we have scored against our rubric, 1,139 (15%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,904 (24%) are Severe.

Which agencies issued them

These figures cover only the 7,838 recalls whose distribution notice names Minnesota specifically. The 73,096 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8476–8500 of 80934

HighFDA (Devices)·Z-0945-2025·2025-01-22
Gynecological Procedure Kits Recalled for Potential Sterile Barrier Packaging Defects
Sklar Instruments is recalling ECONO STERILE gynecological procedure kits due to packaging issues that may compromise the sterile barrier. The affected kits may no longer maintain their sterile condition.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, gynecological procedures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0927-2025·2025-01-22
Sklar Instruments Recalls ECONO STERILE Trousseau Dilator Kits for Packaging Defects
Sklar Instruments is recalling ECONO STERILE trousseau dilator kits (Model 941-0191) distributed nationwide due to packaging issues that may compromise the sterile barrier. Affected healthcare providers should stop use immediately.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0949-2025·2025-01-22
Sklar Instruments ECONO STERILE surgical procedure kits recalled due to packaging defect
Sklar Instruments is recalling ECONO STERILE ALFONSO INFANT SPEC STRL sterile surgical procedure kits nationwide due to packaging issues that may breach the sterile barrier.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814; eyelid surgery
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0961-2025·2025-01-22
VerifyNow P2Y12 Platelet Reactivity Test distributed without FDA market clearance
Accriva Diagnostics distributed the VerifyNow P2Y12 Platelet Reactivity Test (Lot WL1145) without required FDA clearance. Healthcare professionals could use the unapproved test to guide treatment decisions for P2Y12 inhibitor therapy.
Product
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0931-2025·2025-01-22
Medical Procedure Kits Recalled for Potential Sterile Barrier Breach
Sklar Instruments is recalling ECONO STERILE Curette Excavator surgical kits due to packaging issues that may compromise sterile barriers. Affected kits were distributed nationwide.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0953-2025·2025-01-22
ECONO STERILE Orthopedic Probes Recalled for Sterile Barrier Breach Risk
Sklar Instruments recalls 2,500 ECONO STERILE orthopedic probe kits due to packaging issues that may breach the sterile barrier. No illnesses or injuries have been reported.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0918-2025·2025-01-22
Portrait Core Services Software Loss of Patient Monitoring After 425 Days
A software issue in GE's Portrait Core Services medical device software causes loss of patient monitoring capability in the Portrait Central Viewer Application after 425 days of continuous operation.
Product
Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems, Model CSSXB
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0847-2025·2025-01-22
Intuitive Surgical Monopolar Curved Scissors Recalled for Frayed Grip Cables
Intuitive Surgical recalls 355,547 monopolar curved scissors due to increased complaints of frayed or broken grip cables on these reusable surgical instruments.
Product
8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-0835-2025·2025-01-22
Alcon Monarch III D Delivery Cartridge Recalled for Molding Defect Risk
Alcon is recalling 41,718 units of its Monarch III D Delivery Cartridge due to a molding defect that could scratch the intraocular lens during cataract surgery.
Product
Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D delivery cartridge Lens Guide, Intraocular Component: N/A
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-0923-2025·2025-01-22
Tenaculum Forceps for da Vinci Surgical Systems Recalled Due to Pitch Cable Failures
Intuitive Surgical is recalling 8MM Tenaculum Forceps used with da Vinci X/Xi Surgical Systems due to pitch cable failures. These instruments are used for tissue manipulation and retraction during surgical procedures.
Product
8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0866-2025·2025-01-22
Surgical Retractor Instruments Recalled Due to Frayed or Broken Grip Cables
Intuitive Surgical is recalling approximately 9,303 units of 8MM Small Grasping Retractor instruments due to increased complaints of frayed or broken grip cables affecting reusable surgical instruments distributed nationwide and internationally.
Product
8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-0933-2025·2025-01-22
Sklar Instruments Recalls ECONO STERILE Surgical Retractors Due to Packaging Issues
Sklar Instruments is recalling 1,050 ECONO STERILE surgical retractors nationwide due to packaging defects that may compromise sterility. The affected kits have potential breaches in their sterile barriers.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267; 4) ECONO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0962-2025·2025-01-22
Olympus LithoCrushV Mechanical Lithotriptor Recalled for Distal Tip Tearing Risk
Olympus Corporation recalls the LithoCrushV Single Use Mechanical Lithotriptor due to potential distal tip tearing during endoscopic procedures. The FDA Class II recall affects 989 units distributed nationwide.
Product
LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0851-2025·2025-01-22
Intuitive Surgical Micro Forceps Recalled Due to Grip Cable Defects
Intuitive Surgical is recalling 8MM Black Diamond Micro Forceps (Model 470033) due to complaints of frayed or broken grip cables. The defect affects 1,111 units distributed nationwide and internationally.
Product
8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-0943-2025·2025-01-22
ECONO STERILE medical procedure kits recalled for potential sterile barrier breach
Sklar Instruments is recalling three models of ECONO STERILE medical procedure kits nationwide due to packaging issues that may breach the sterile barrier. No injuries or illnesses have been reported.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A; 3) ECONO STERILE KEVORKIAN CURET W/O BAS STER25, Model Number 96-4145A; cervical
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0846-2025·2025-01-22
Stryker Blueprint Glenoid Pin Guide May Disassemble During Shoulder Surgery
The metal tube of the Stryker Blueprint Glenoid Pin Guide may disassemble from the plastic handle. This can prevent the guidance system from detecting the device, potentially prolonging surgery or requiring a switch to conventional surgical methods.
Product
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0936-2025·2025-01-22
ECONO STERILE Medical Procedure Kits Recalled for Sterile Barrier Compromise
Sklar Instruments recalls ECONO STERILE medical procedure kits (300 units nationwide) due to packaging issues that may compromise sterile barrier integrity.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630; 2) ECONO STERILE BACKHAUS TWL CLP STER 5.25 25, Model Number 96-2636; general purpose clips
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0938-2025·2025-01-22
Surgical Suction Tubes Recalled for Sterile Packaging Defects
ECONO STERILE suction tubes and surgical instruments (150 units, nationwide) are recalled for packaging defects that may breach the sterile barrier and create infection risk during medical procedures.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177; 3) ECONO STERILE FRAZIER TUBE 6FR STERILE CS/25, Model Number 96-5434; 4) ECONO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0876-2025·2025-01-22
8MM Maryland Bipolar Forceps Recalled for Frayed Grip Cable
Intuitive Surgical is recalling 68,458 units of its 8MM Maryland Bipolar Forceps due to increased complaints about frayed or broken grip cables on the reusable surgical instruments.
Product
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-0860-2025·2025-01-22
Intuitive Surgical Tenaculum Forceps Recalled for Frayed or Broken Grip Cables
Intuitive Surgical is recalling 11,162 units of 8MM Tenaculum Forceps (Model 470207) due to increased complaints of frayed or broken grip cables on reusable surgical instruments. Users should discontinue use immediately.
Product
8MM,TENACULUM FORCEPS,IS4000¿ REF 470207
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-0958-2025·2025-01-22
Change Healthcare Cardiology Hemo software autosave defect recall
A software defect in Change Healthcare Cardiology Hemo software may cause clinicians to administer incorrect medications. The defect affects the autosave mechanism in affected versions.
Product
Change Healthcare Cardiology Hemo software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0944-2025·2025-01-22
Gynecological Speculum Kits Recalled for Potential Sterile Barrier Breach
Sklar Instruments is recalling ECONO STERILE gynecological speculum kits due to packaging issues that may compromise sterility. No injuries have been reported.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERILE GRAVES SPEC STRL MD BX/25, Model Number 96-2605; 3) ECONO STERILE GRAVES SPEC STRL LG BX/25, Model Number 96-2607; 4) ECONO STERILE PEDER
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0926-2025·2025-01-22
ECONO STERILE Medical Procedure Kits Recalled for Packaging Defects
Sklar Instruments is recalling ECONO STERILE medical procedure kits due to packaging issues that may compromise the sterile barrier and allow contamination.
Product
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0929-2025·2025-01-22
Surgical Retractor Kits Recalled for Potential Sterile Barrier Breach
Sklar Instruments is recalling ECONO STERILE surgical retractor kits due to packaging defects that may result in a breach of the sterile barrier. 75 units nationwide have been affected.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A; 2) ECONO STERILE WEITLANER RETR BL 2X3 4.5"CS25, Model Numbers: 96-2203A; 3) ECONO STERILE WEITLANER RETR BL 3X4 5.5"CS25, Model Numbers: 96-2207A;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0856-2025·2025-01-22
8MM Maryland Bipolar Forceps Recalled Due to Frayed Grip Cables
Intuitive Surgical is recalling 8MM Maryland Bipolar Forceps due to increased complaints about frayed or broken grip cables on these reusable surgical instruments. Approximately 7,132 units have been distributed.
Product
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
Category
Medical Device
Distribution
52 states