Hazard

Class Ii recalls

1,428 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,428
Critical: 0
Severe: 0
Most recent: 2026-07-08

Of the 1,428 class ii recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all class ii recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

626–650 of 1428

HighFDA (Drugs)·D-0442-2026·2026-04-15
Fagron vancomycin infusion bags recalled over sterility and detaching port part
Fagron Sterile Services is recalling Vancomycin HCl 1 gram in 250 mL sodium chloride bags for lack of assurance of sterility and because a blue break-off part could detach from the administration port.
Product
Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0446-2026·2026-04-15
Teva isotretinoin 40 mg capsules recalled as superpotent and subpotent
Teva is recalling three lots of Isotretinoin Capsules, USP, 40 mg because the product was found to be superpotent and subpotent. 8,376 packages are affected.
Product
ISOTRETINOIN — ISOTRETINOIN (ISOTRETINOIN)
Category
Drug
Distribution
4 states
HighFDA (Devices)·Z-1804-2026·2026-04-15
Stryker tourniquet cuffs may detach from the bladder welding connection
Stryker Sustainability Solutions is recalling Color Cuff tourniquet cuffs because the cuff can detach from the bladder at the welding connection, leaving it unable to maintain pressure.
Product
Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solution Color Cuff 18" (Red), Quick Connect Dual Port Single Bladder REF 5921-018-135 Stryker Sustainability Solution Color Cuff 18" (Red)
Category
Medical Device
Distribution
41 states
HighFDA (Devices)·Z-1787-2026·2026-04-15
Cook Medical nitinol stone extractors labeled with overstated expiration dates
Cook Medical is recalling NCompass Nitinol Stone Extractors because affected lots were labeled with expiration dates that exceed the product's true shelf life. 70 units are affected.
Product
COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1781-2026·2026-04-15
Cook Medical tracheostomy introducer sets labeled with overstated expiration dates
Cook Medical is recalling Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Sets because affected lots were labeled with expiration dates that exceed the true shelf life. 484 units are affected.
Product
COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1782-2026·2026-04-15
Cook Medical extubation set labeled with an overstated expiration date
Cook Medical is recalling Staged Extubation Sets because affected lots were labeled with expiration dates that exceed the product's true shelf life. 95 units are affected.
Product
COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1790-2026·2026-04-15
Cook Medical chest tube tray labeled with an overstated expiration date
Cook Medical is recalling Thal-Quick Chest Tube Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. Two units are affected.
Product
COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1774-2026·2026-04-15
Molded Products Luer cap sets recalled after threaded sleeve detachment complaint
Molded Products is recalling the MPC-130 See Luer Cap Set following a confirmed complaint that the threaded sleeve was not engaged and became detached. 26,900 units are affected.
Product
See Luer Cap Set, MPC-130, set, administration, intravascular
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0473-2026·2026-04-15
Teva clonidine 0.2 mg patches recalled over unapproved raw material use
Teva is recalling two lots of Clonidine Transdermal System, USP, 0.2 mg/day, citing CGMP deviations involving the use of an unapproved raw material. 62,136 cartons are affected.
Product
CLONIDINE TRANSDERMAL SYSTEM — CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE)
Category
Drug
Distribution
0 states
ModerateFDA (Devices)·Z-1653-2026·2026-04-15
Siemens ARTIS imaging systems may display an inflated patient dose reading
Siemens ARTIS pheno and ARTIS Icono systems may sporadically display a major increase in the x-ray dose applied, although the actual dose applied remains within system settings and regulatory limits.
Product
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0472-2026·2026-04-15
Teva clonidine transdermal patches recalled over unapproved raw material use
Teva is recalling two lots of Clonidine Transdermal System, USP, 0.1 mg/day, citing CGMP deviations involving the use of an unapproved raw material. 124,054 cartons are affected.
Product
CLONIDINE TRANSDERMAL SYSTEM — CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0474-2026·2026-04-15
Teva clonidine 0.3 mg patches recalled over unapproved raw material use
Teva is recalling three lots of Clonidine Transdermal System, USP, 0.3 mg/day, citing CGMP deviations involving the use of an unapproved raw material. 113,943 cartons are affected.
Product
CLONIDINE TRANSDERMAL SYSTEM — CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE)
Category
Drug
Distribution
0 states
HighFDA (Devices)·Z-1654-2026·2026-04-08
Paradise renal denervation catheter unit distributed despite scrapping designation
One Paradise Ultrasound Renal Denervation catheter was distributed although it was a nonconforming product that should have been scrapped and not used in humans.
Product
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1753-2026·2026-04-08
Burlington Medical thyroid shields may lose radiation attenuation over time
Burlington Medical is recalling thyroid shields over the potential for attenuation degradation over time, which decreases the product's usable lifespan. 41,962 units are affected.
Product
Burlington Medical, Thyroid Shield.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1678-2026·2026-04-08
Philips Azurion 7 M20 X-ray may not start from foot switch
Philips has identified instances where X-ray imaging on the Azurion 7 M20 may not initiate, or may run intermittently, when the wired foot switch is used. 5,167 units are affected.
Product
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0409-2026·2026-04-08
Quality Choice irritation relief eye drops recalled over sterility assurance
Quality Choice Eye Drops Irritation Relief, containing tetrahydrozoline HCl and zinc sulfate, are being recalled for lack of assurance of sterility. 182,424 bottles are affected.
Product
QUALITY CHOICE EYE DROPS IRRITATION RELIEF — QUALITY CHOICE EYE DROPS IRRITATION RELIEF (TETRAHYDROZOLINE HCL, ZINC SULFATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2604-2025·2025-10-01
CT 6000 scanners recalled because the patient table may drop unexpectedly
Philips CT 6000 systems, model 728307, are recalled because the patient support table may descend unexpectedly due to ball screw misalignment after a replacement. 6 units are affected.
Product
Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2607-2025·2025-10-01
Sofmed Breathables contact lenses recalled over an invalid sterilization cycle
Sofmed Breathables contact lenses from one lot are recalled because the lot was manufactured with an invalid sterilization cycle. 180 units are affected.
Product
Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2596-2025·2025-10-01
Brilliance 16 and 6 slice scanners recalled over patient table descent
Philips Brilliance 16 Power, Brilliance CT 16 Slice and Brilliance CT 6 Slice systems are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 73 units are affected.
Product
Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Number: 728256.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2606-2025·2025-10-01
MyDay toric contact lenses recalled after one lot used invalid sterilization
MyDay Toric contact lenses from one lot are recalled because the lot was manufactured with an invalid sterilization cycle. 4,140 units are affected.
Product
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2629-2025·2025-10-01
Allura Xper FD20 Biplane OR Table recalled over internal component deterioration
Philips Allura Xper FD20 Biplane OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 5 units are affected.
Product
Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2636-2025·2025-10-01
Vessel harvesting systems recalled after out-of-box failures in harvesting tool jaws
Vasoview Hemopro 3 Endoscopic Vessel Harvesting Systems are recalled after out-of-box failures including deformed jaw attachments, jaws not fully closed and lifted heater wire. 98 units are affected.
Product
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting kit designed for use with a 7 mm endoscope to cut and cauterize vessel branches.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2628-2025·2025-10-01
Allura Xper FD20 OR Table recalled over CMOS battery and drive deterioration
Philips Allura Xper FD20 OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 174 units are affected.
Product
Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2600-2025·2025-10-01
Ingenuity CT scanners recalled because the patient couch may descend unexpectedly
Philips Ingenuity CT systems are recalled because the patient support table may descend unexpectedly to its lowermost position due to ball screw misalignment after a replacement. 285 units are affected.
Product
Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 728326.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2615-2025·2025-10-01
Orthopedic inserter adapters recalled over weld breakage between pin and holder
Ortoma Inserter Adapter OTD devices are recalled because of a weld breakage between the pin and the inserter holder. 261 devices are affected.
Product
Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle Straight REF 30-202 Model Number: 1001 UDI-DI code: 07350137520593 Reamer Adapter OTD REF 30-157 Model Number: 1003 UDI-
Category
Medical Device
Distribution
Distributed nationwide