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.

901–925 of 1428

HighFDA (Devices)·Z-2479-2025·2025-09-03
Surgical kits recalled because Foley tray inserts carry incorrect product information
Medline kits containing BD SureStep Foley Tray Systems are recalled because the trays include incorrect product information insert sheets. Four units were distributed, all from the LAVH MINOR SKU.
Product
Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTOMY DYNJ908819B KIT CRANIOTOMY (only units from SKU DYNJG001004A LAVH MINOR were distributed)
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2342-2025·2025-09-03
C-arm imaging systems recalled over missing lead tape in collimator covers
GE HealthCare OEC 9800 and OEC 9900 Elite C-arm systems are recalled because impacted units are missing the full layer of lead tape in the collimator covers, slightly increasing radiation exposure.
Product
GE HealthCare OEC 9900 Elite C-arm Systems.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2418-2025·2025-09-03
NovoTHOR Gen 3.0 unit recalled because gas strut may detach from canopy
A single NovoTHOR Gen 3.0 Reg PRX unit, model S2189, is recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift.
Product
Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissu
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2416-2025·2025-09-03
NovoTHOR light therapy devices recalled over welded nut that may shear
NovoTHOR devices, model S2188, are recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift. 80 units are affected.
Product
Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature fo
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2461-2025·2025-09-03
Surgical driver systems recalled over out of the box driver wobble
IPC Powerease System units, REF 2300000, are recalled because of out of the box wobble of the driver. 214 units are affected.
Product
IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE S
Category
Medical Device
Distribution
25 states
ModerateFDA (Devices)·Z-2475-2025·2025-09-03
Anti-Xa test kits recalled over potential contamination by fibrinogen reagents
STA-Liquid Anti-Xa 8 kits are recalled because of the potential for contamination by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 126,200 units are affected.
Product
STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2474-2025·2025-09-03
Anti-Xa 4 test kits recalled over potential fibrinogen reagent contamination
STA-Liquid Anti-Xa 4 kits are recalled because of the potential for contamination by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 116,600 units are affected.
Product
STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2438-2025·2025-09-03
Dialysis control units recalled over false blood leak detection alarms
PrisMax V3 Control Units are recalled because of unexpected blood leak alarms when no leak is present, or difficulty normalizing the blood leak detector. 2,449 units are affected.
Product
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2437-2025·2025-09-03
Hemodialysis delivery systems recalled over priming alarm requiring additional priming cycles
PrisMax V2-US hemodialysis delivery systems are recalled because a low deaeration chamber level at post-priming tests may trigger alarm T2309, resulting in multiple additional priming cycles. 4,772 units are affected.
Product
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Category
Medical Device
Distribution
0 states
ModerateFDA (Drugs)·D-0596-2025·2025-09-03
Acetaminophen injection containers recalled after discoloration found in one lot
Baxter Acetaminophen Injection 1000 mg/100 mL in Viaflo containers, lot 24A27G66, is recalled nationwide because of discoloration. 13,000 containers are affected.
Product
ACETAMINOPHEN — ACETAMINOPHEN (ACETAMINOPHEN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2473-2025·2025-09-03
Coagulation analyzers recalled over potential reagent contamination in anti-Xa testing
STA Satellite analyzers are recalled because of the potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 3,650 units are affected.
Product
STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologic assays.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2421-2025·2025-09-03
Dental implant locating kits recalled over thread defect limiting full engagement
Atlantis IO FLO-S Kits are recalled because a thread defect stops the device fully engaging an implant or analog, engaging about two rotations instead of five. 102 units are affected.
Product
Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure wit
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2453-2025·2025-09-03
Drug transfer devices recalled for shipping without US instructions for use
BD PhaSeal closed system drug transfer devices are recalled because they were shipped to the US market without a US version of the instructions for use. 3,884,670 units are affected.
Product
BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 515004 BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 515005 BD PhaSeal Protector (P14), REF: 515100 BD PhaSeal Protector (P21), REF:
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2419-2025·2025-09-03
Light therapy devices recalled over welded nut that may shear off
Two NovoTHOR Gen 3.0 Reg PRX units are recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift.
Product
Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissu
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0523-2025·2025-09-03
Tzatziki sauce recalled because label omits keep refrigerated storage instruction
Gelson's Tzatziki, 8 oz, sold in the firm's Southern California grocery stores, is recalled because the label does not carry the storage instruction to keep refrigerated.
Product
Gelson's Tzatziki; Old-World Family Recipe Real Greek Yogurt California-Made; NET WT. 8OZ (226g) UPC: 23631-10268
Category
Food
Distribution
1 state
ModerateFDA (Food)·H-0524-2025·2025-09-03
Low sodium classic hummus recalled over missing keep refrigerated storage instruction
Gelson's Low Sodium No Cholesterol Classic Hummus, 10 oz, sold in the firm's Southern California grocery stores, is recalled because the label does not carry the storage instruction to keep refrigerated.
Product
Gelson's Hummus; Low Sodium No Cholesterol Classic NET WT 10OZ (283g) UPC: 23631-10260
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-2477-2025·2025-09-03
Medication dispensing stations recalled because antivirus software was not consistently installed
BD Pyxis MedStation and Anesthesia Station devices are recalled because antivirus software was not consistently installed during implementation. 8,353 devices are affected, 6,738 of them in the US.
Product
BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES / 10885403477836 / 327 BD Pyxis" MedStation" ES (Main) / 10885403512667 / 323
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0532-2025·2025-09-03
Passionflower herb extract recalled over misbranding of the bulk ingredient
Passionflower Herb Powdered Extract 4% in bulk packaging is recalled for misbranding of the ingredient. The recall covers 775 kg sent to a single consignee in North Carolina.
Product
Passionflower Herb Powdered Extract 4%, bulk packaging, individual large box, corrugated cardboard box with plastic liner .
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-2417-2025·2025-09-03
NovoTHOR XL devices recalled over failed welded nut detaching gas strut
NovoTHOR XL devices, model S2190, are recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift. 55 units are affected.
Product
Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2439-2025·2025-09-03
Blood warmer units recalled because system may not detect inserted bag
TherMax Blood Warmer Units, an accessory to the PrisMax system, are recalled because the system may be unable to detect a bag on the unit, causing setup difficulty or alarm T2284. 7,432 units are affected.
Product
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2476-2025·2025-09-03
Fibrinogen test kits recalled over potential cross-contamination in heparin assays
STA-Fibrinogen 5 kits are recalled because of the potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in heparin applications. 829,800 units are affected, 245,200 of them in the US.
Product
STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen levels in human citrated plasma by the clotting method of
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0525-2025·2025-09-03
Hummus recalled because labels omit keep refrigerated storage instructions
Gelson's Hummus, 8 oz, sold in the firm's Southern California grocery stores, is recalled because the label does not carry the storage instruction to keep refrigerated.
Product
Gelson's Hummus; Mediterranean Old World Family Recipe California-Made No Added Oils NET WT 8OZ (226g) UPC: 23631-10261
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-2422-2025·2025-09-03
Atlantis IO FLO-S kits recalled over thread defect limiting implant engagement
Atlantis IO FLO-S Kits, catalog A04S / 68020034, are recalled because a thread defect stops the device fully engaging an implant or analog, engaging about two rotations instead of five. 780 units are affected.
Product
Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring che
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0526-2025·2025-09-03
Red bell pepper hummus recalled because label omits keep refrigerated instruction
Gelson's Red Bell Pepper Hummus, 8 oz, sold in the firm's Southern California grocery stores, is recalled because the label does not carry the storage instruction to keep refrigerated.
Product
Gelson's Hummus; Red Bell Pepper Old World Family Recipe California-Made No Added Oils NET WT 8OZ (226g) UPC: 23631-10262
Category
Food
Distribution
1 state
LowFDA (Devices)·Z-2463-2025·2025-09-03
Leg massagers recalled over documentation error and misleading color packaging claim
HoMedics Air Compression Leg Massagers, model SR-160HJ, are recalled for a regulatory documentation error and a misleading color packaging claim. The record states the affected lots do not present a risk of harm.
Product
Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description: Powered Inflatable Tube Massager used on the leg. The Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and f
Category
Medical Device
Distribution
Distributed nationwide