State

Illinois product recalls

72,940 recalls have nationwide distribution and so reach Illinois. 11,603 additional recalls listed Illinois specifically in their distribution scope.

What the numbers show

Total: 11,603
Critical: 2,039
Severe: 2,516
Most recent: 2026-09-09

Of the 11,603 recalls naming Illinois we have scored against our rubric, 2,039 (18%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,516 (22%) are Severe.

Which agencies issued them

These figures cover only the 11,603 recalls whose distribution notice names Illinois specifically. The 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3501–3525 of 84543

HighFDA (Devices)·Z-1245-2026·2026-02-11
Surgical laser probes recalled over voids in sterile pouch seals
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Product
Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No. VS0130.25 4. 25GA Laser Probe Illuminated Curved Cat No. VS0125.25B 5. 25GA Laser Probe MaxReach Cat No. VS0140.25
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1267-2026·2026-02-11
Vivoo sodium and hydration tests recalled over missing premarket clearance
Changchun Wancheng Bio-Electron is recalling 3,300 units of Vivoo Sodium Test because tests requiring a 510(k) were distributed before they could be legally marketed.
Product
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0482-2026·2026-02-11
Frozen half shell oysters recalled over potential norovirus contamination
Khee Trading is recalling 7,306 cases of frozen half shell oysters imported from the Republic of Korea over potential norovirus contamination.
Product
Product is Frozen Half Shell Oysters in 15-16 pound blocks. Packaged in generic brown cardboard boxes. Side panel reads: HAFL SHELL OYSTER Spec: 144PCS; Imported by: Khee Trading Inc., Compton, CA Side panel reads: Method of harvest: Farm Raised Country of Origin: Republic of Kor
Category
Food
Distribution
7 states
HighFDA (Food)·H-0478-2026·2026-02-11
Soursop sea moss gel recalled over potential Clostridium botulinum contamination
Diva Fam is recalling Sea Moss Gel Superfood in the Soursop variety over potential Clostridium botulinum contamination.
Product
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Soursop- UPC# 5061033691875
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1249-2026·2026-02-11
Vitrectomy convenience kits recalled over voids in sterile pouch seals
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Product
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1244-2026·2026-02-11
Single use vitrectomy lenses recalled over voids in pouch seals
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Product
Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1299-2026·2026-02-11
X-ray systems recalled over welded contactor contacts that may overheat
FUJIFILM Healthcare Americas is recalling 16 FDR Visionary Suite systems because welded contactor contacts may keep supplying current after the device is switched off.
Product
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1232-2026·2026-02-11
Surgical robots recalled over a software error hiding failed arm diagnostics
Intuitive Surgical is recalling 219 da Vinci X, Xi and da Vinci 5 systems because a software error allowed instrument arms failing an important diagnostic test to remain in clinical use.
Product
Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components:
Category
Medical Device
Distribution
30 states
HighFDA (Devices)·Z-1237-2026·2026-02-11
Peripheral screws recalled after a lot was labeled the wrong length
Tornier is recalling 427 Perform Reversed peripheral screws because a lot labeled 5.0mm x 18mm actually contains 5.00mm x 14mm screws.
Product
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0477-2026·2026-02-11
Five blend sea moss gel recalled over potential Clostridium botulinum
Diva Fam is recalling Sea Moss Gel Superfood in the 5 Blend in 1 variety over potential Clostridium botulinum contamination.
Product
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. 5 Blend in 1- UPC# 5061033690052
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·H-0467-2026·2026-02-11
Mango sea moss gel recalled over potential Clostridium botulinum contamination
Diva Fam is recalling Sea Moss Gel Superfood in the Mango variety over potential Clostridium botulinum contamination.
Product
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Mango- UPC# 5065006235875
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1304-2026·2026-02-11
pTau 217 plasma controls recalled over falsely elevated ratio results
Fujirebio Diagnostics is recalling 148 units of Lumipulse pTau 217 Plasma Controls because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.
Product
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personn
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1251-2026·2026-02-11
Retractable membrane polishers recalled over voids in sterile pouch seals
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Product
Tecfen Retractable Membrane Polisher, QTPR1267-23
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1243-2026·2026-02-11
Prostate imaging software recalled over accessories that may fail on Windows 10
Focalyx Technologies is recalling 18 units of Focalyx Fusion because accessories may not function properly with Windows 10, which may cause patient harm during biopsy or delay treatment.
Product
Focalyx Fusion
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1264-2026·2026-02-11
Vivoo pH tests recalled over missing FDA premarket clearance
Changchun Wancheng Bio-Electron is recalling 500 units of the Vivoo pH Test because tests requiring a 510(k) were distributed before they could be legally marketed.
Product
Vivoo pH Test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1261-2026·2026-02-11
Typhoid antigen tests recalled over missing FDA premarket clearance
Changchun Wancheng Bio-Electron is recalling 1,000 units of the S. Typhi/Para Typhi A Antigen test because it was distributed before it could be legally marketed.
Product
S. Typhi/Para Typhi A Antigen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1303-2026·2026-02-11
pTau 217 plasma calibrators recalled over falsely elevated ratio results
Fujirebio Diagnostics is recalling 117 units of Lumipulse G pTau 217 Plasma Calibrators because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.
Product
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration cu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1256-2026·2026-02-11
Scleral IOL markers recalled over voids in sterile pouch seals
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Product
Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0470-2026·2026-02-11
Apple cinnamon sea moss gel recalled over potential Clostridium botulinum
Diva Fam is recalling Sea Moss Gel Superfood in the Apple and Cinnamon flavour over potential Clostridium botulinum contamination.
Product
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Apple and Cinnamon- UPC# 5065006235776
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·H-0476-2026·2026-02-11
Mango pineapple sea moss gel recalled over potential Clostridium botulinum
Diva Fam is recalling Sea Moss Gel Superfood in the Mango and Pineapple variety over potential Clostridium botulinum contamination.
Product
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Mango and Pineapple- UPC# 5065006235301
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1266-2026·2026-02-11
Vaginal pH tests recalled over missing FDA premarket clearance
Changchun Wancheng Bio-Electron is recalling 3,000 units of Vivoo Vaginal pH Test because tests requiring a 510(k) were distributed before they could be legally marketed.
Product
Vivoo Vaginal pH Test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1255-2026·2026-02-11
Backflush instruments recalled over voids in sterile pouch seals
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Product
Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1241-2026·2026-02-11
CT software applications recalled because they lack FDA clearance
Siemens is removing three software applications from five NAEOTOM Alpha.Prime CT systems because the applications have not received FDA 510(k) clearance.
Product
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1284-2026·2026-02-11
Sphincterotome KD-VC433Q-0730 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC433Q-0730, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency c
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1278-2026·2026-02-11
Distal wire guided sphincterotomes recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0720, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide