State

Wisconsin product recalls

72,940 recalls have nationwide distribution and so reach Wisconsin. 8,408 additional recalls listed Wisconsin specifically in their distribution scope.

What the numbers show

Total: 8,408
Critical: 1,547
Severe: 1,957
Most recent: 2026-09-09

Of the 8,408 recalls naming Wisconsin we have scored against our rubric, 1,547 (18%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,957 (23%) are Severe.

Which agencies issued them

These figures cover only the 8,408 recalls whose distribution notice names Wisconsin specifically. The 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

4426–4450 of 81348

HighFDA (Devices)·Z-0517-2026·2025-11-26
Laparotomy kits recalled over smoke pencils that may activate unprompted
Medline is recalling 28,679 laparotomy convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTOMY CDS, REF CDS860015X; 3) MINOR LAPAROTOMY CDS, REF CDS860016R; 4) MINOR LAPAROTOMY CDS, REF CDS860016S; 5) LAPAROTOMY CDS #31-RF, REF CDS860062S; 6) LAPAROSCOPY CDS, REF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0515-2026·2025-11-26
Breast biopsy packs recalled over smoke pencils that may activate
Medline is recalling 301 breast biopsy and mastectomy convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREAST PACK, REF DYNJ65361A; 3) BREAST BIOPSY/MASTECTOMY, REF DYNJ908839A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0572-2026·2025-11-26
Nephrostomy balloon kits recalled after containing the wrong sized catheter
Olympus is recalling 60 Nephro-EZDilate nephrostomy balloon catheter kits because they contained a 4mm x 4cm urinary tract balloon instead of the correct 8mm x 15cm nephrostomy balloon.
Product
Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0530-2026·2025-11-26
Neuro and joint kits recalled over smoke pencils that may activate
Medline is recalling 40,151 neurosurgery, back and joint convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS780147N; 3) INSTRUMENTED BACK CDS, REF CDS780148R; 4) NEURO-LAMI CDS, REF CDS780208I; 5) TOTAL HIP, REF CDS920027Y; 6) TOTAL KNEE, REF CDS940072Y; 7) TOTA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0503-2026·2025-11-26
Oncology software recalled because appended medication orders may mismatch the schedule
Elekta is recalling four systems running MOSAIQ Oncology Information System builds 3.1.3 through 3.2.3.0 because appended wave medication orders may not match the intended schedule.
Product
MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0516-2026·2025-11-26
Head and neck ENT kits recalled over smoke pencil activation defect
Medline is recalling 3,078 head and neck, ENT and thoracotomy convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2) HEAD AND NECK, REF CDS984259P; 3) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F; 4) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I; 5) THORACOTOMY HARPER PACK-LF, REF DYNJ0161795F; 6) MAJOR ENT MZ PAC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0529-2026·2025-11-26
Minor eye trays recalled over smoke pencils that may stay active
Medline is recalling 345 Minor Eye Tray #81 convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) MINOR EYE TRAY #81, REF DYNJ27466T.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0533-2026·2025-11-26
Hemostasis valves recalled because the valve cap may remain depressed
Merit Medical is recalling 217,141 PhD Hemostasis Valves because a manufacturing defect can leave the valve cap depressed, leading to potential leakage and possible hemorrhage.
Product
PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-0526-2026·2025-11-26
Caesarean section kits recalled over smoke pencils that may activate
Medline is recalling 11,032 C-section convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-SECTION CDS, REF CDS985282F; 4) C-SECTION PACK, REF DYNJ02577D; 5) C-SECTION PACK-LF, REF DYNJ0536924U; 6) C-SECTION PACK-LF, REF DYNJ0551169V; 7) C-SECT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0511-2026·2025-11-26
Local basic kits recalled over smoke pencils that may stay active
Medline is recalling 48 LOCAL BASIC convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0522-2026·2025-11-26
Neuro shunt and laminectomy kits recalled over smoke pencil activation defect
Medline is recalling 1,315 neurosurgery convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; 2) ACDF CDS, REF CDS941061M; 3) NEURO PACK-LF, REF DYNJ0038440C; 4) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S; 5) NEURO-ORTHO EXTRAS, REF DYNJ44882M; 6) LAMINECTOMY, REF DYNJ903870F.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0520-2026·2025-11-26
Basin packs recalled over smoke pencils that may activate unprompted
Medline is recalling 1,921 basin convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ37698L; 2) BASIN PACK, REF DYNJ50123D; 3) MAJOR BASIN PACK, REF DYNJ59816A; 4) OSC BASIN PACK, REF DYNJ68217A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0504-2026·2025-11-26
Luer tip caps recalled after trays failed routine biocompatibility testing
Becton Dickinson is recalling 4,180,000 BD Luer Tip Caps after internal testing confirmed that certain device trays failed routine biocompatibility testing.
Product
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0541-2026·2025-11-26
Flow cytometers recalled over software that crashes during sample acquisition
Beckman Coulter is recalling 25 DxFLEX Flow Cytometers because a software error crashes the system during acquisition on a patient sample when running a customer defined protocol.
Product
DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light s
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·26114·2025-11-26
Pressure mounted safety gates recalled over a torso sized opening
About 100 Ikuso pressure-mounted safety gates are being recalled because a child's torso can fit through the opening between the gate slat and the side wall.
Product
Ikuso Safety Gates
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0518-2026·2025-11-26
Port insertion packs recalled over smoke pencils that may stay live
Medline is recalling 12 Port Insertion Pack convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0509-2026·2025-11-26
ECMO consoles recalled after eleven reports of a blank touchscreen error
Medtronic is recalling 167 MC3 VitalFlow Consoles after eleven reports of an E70 error code that leaves the touchscreen blank for up to two minutes during operation.
Product
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0547-2026·2025-11-26
Clot activator microtubes recalled over an inadequate quality system
ASP Global is recalling 27,950 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with clot activator, over an inadequate quality system.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0554-2026·2025-11-26
Amber clot activator microtubes recalled over an inadequate quality system
ASP Global is recalling 1,500 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with clot activator in an amber microtube, over an inadequate quality system.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog Number: 07 7450 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger o
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0546-2026·2025-11-26
Serum separator microtubes recalled over unvalidated manufacturing processes
ASP Global is recalling 64,850 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with clot activator and serum separator gel, over an inadequate quality system.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7121 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the f
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0564-2026·2025-11-26
Capillary end caps recalled over an inadequate quality system
ASP Global is recalling 620,502 SAFE-T-FILL end caps for blood gas capillaries over an inadequate quality system with unvalidated manufacturing processes.
Product
SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0172-2026·2025-11-26
Perineal antiseptic recalled over contamination found at the manufacturing facility
DermaRite Industries is recalling 16,006 units of PeriGiene health care antiseptic because it was made at the same facility where other products were found contaminated.
Product
PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0171-2026·2025-11-26
McKesson skin protectant recalled over contamination found at the manufacturing facility
DermaRite Industries is recalling 5,876 units of McKesson Skin Protectant with lanolin because it was made at the same facility where other products were found contaminated.
Product
SKIN PROTECTANT WITH LANOLIN — SKIN PROTECTANT WITH LANOLIN (LANOLIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0176-2026·2025-11-26
Alcohol hand foam recalled over contamination found at the manufacturing facility
DermaRite Industries is recalling 15,465 cartridges of San-E-Foam alcohol hand sanitiser because it was made at the same facility where other products were found contaminated.
Product
San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-107-34
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0173-2026·2025-11-26
Petrolatum barrier ointment recalled over contamination found at the manufacturing facility
DermaRite Industries is recalling 381,619 units of PeriGuard Ointment because it was made at the same facility where other products and lots were found to be contaminated.
Product
PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC 61924-205-07) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Category
Drug
Distribution
Distributed nationwide