Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

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2401–2425 of 13381

HighFDA (Devices)·Z-2453-2025·2025-09-03
BD PhaSeal Closed System Drug Transfer Devices Missing U.S. Instructions
BD PhaSeal closed system drug transfer devices sold in the U.S. lacked required instructions for use. Proper guidance is critical for safe operation and protecting healthcare workers from hazardous drug exposure.
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
HighFDA (Devices)·Z-2475-2025·2025-09-03
STA-Liquid Anti-Xa 8 Laboratory Test Kit Recall Due to Potential Reagent Contamination
Diagnostica Stago is recalling STA-Liquid Anti-Xa 8 test kits used to measure heparin levels in blood due to potential contamination by Fibrinogen reagents. No patient harm has been reported.
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
HighFDA (Devices)·Z-2470-2025·2025-09-03
Medical Surgery Kits Recalled for Sterilization Assurance Failure
American Contract Systems is recalling 1,094 laparoscopy and pelviscopy procedure kits distributed to Illinois and Louisiana because the company cannot confirm sterilization requirements were met for certain components.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2441-2025·2025-09-03
Orascoptic surgical loupes recalled due to nickel allergy risk
Orascoptic Surgical Acuity is recalling surgical loupes with Phantom Frames because the nickel in the nose pads can cause allergic reactions. The recall affects 10,611 units distributed worldwide.
Product
Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2438-2025·2025-09-03
Hemodialysis Delivery System Blood Leak Detector False Alarms Recall
VANTIVE US HEALTHCARE recalls PrisMax V3 hemodialysis control units due to false blood leak detection alarms and detector normalization failures that could interfere with actual leak detection.
Product
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2423-2025·2025-09-03
Orthopedic Canal Filling Stem Implants Recalled for Unknown Substance
Onkos Surgical is recalling 30 units of ELEOS BOWED CANAL FILLING STEMS nationwide due to an unidentified substance found during a retrospective evaluation. The substance's impact is unknown.
Product
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2474-2025·2025-09-03
STA-Liquid Anti-Xa Diagnostic Test Kit Recalled for Potential Contamination
Diagnostica Stago is recalling STA-Liquid Anti-Xa diagnostic test kits due to potential contamination from fibrinogen reagents. The kits measure anticoagulant medication levels in clinical laboratories nationwide and internationally.
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
HighFDA (Devices)·Z-2467-2025·2025-09-03
Medical Procedure Kits Recalled Due to Unconfirmed Sterilization
American Contract Systems is recalling 6,617 medical procedure kits because the company cannot confirm sterilization requirements were met. The affected kits were distributed to healthcare facilities in Illinois and Louisiana.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G; 4) CYSTO PACK, Model/Item N
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2443-2025·2025-09-03
Surgical Loupes Recalled Due to Nickel Allergy Risk in Nose Pads
Orascoptic Surgical Acuity is recalling 74 Orascoptic Superior Visualization Phantom Essential kits because the nose pads contain nickel, which may cause allergic reactions in users with nickel sensitivity. The kits were manufactured between June 6, 2023, and May 14, 2025.
Product
Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2341-2025·2025-09-03
GE HealthCare OEC C-Arm Systems: Missing Lead Shielding Increases Radiation Exposure
GE Medical Systems is recalling certain OEC 9800 and OEC 9900 Elite C-arm systems with missing lead tape in collimator covers, causing small increases in radiation exposure to patients and operators. The defect is not detectable by users.
Product
GE HealthCare OEC 9800.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2415-2025·2025-09-03
Spectrum IQ Infusion Pumps Recalled for Potential Lubricant Failure
Baxter is recalling six Spectrum IQ Infusion Pumps distributed to Arizona and Florida due to potential grease breakdown in the motor mechanism, which could result in excessive medication delivery.
Product
Spectrum IQ Infusion Pump, Product Code 3570009
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2461-2025·2025-09-03
Medtronic IPC Powerease Surgical System Recalled for Driver Wobble
Medtronic is recalling 214 IPC Powerease surgical systems due to out-of-box wobble of the driver component. Units were distributed across 25 U.S. states and multiple countries.
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
HighFDA (Devices)·Z-2464-2025·2025-09-03
Cardiac and Vascular Surgical Procedure Kits Recalled for Sterilization Assurance Issues
American Contract Systems is recalling 31,506 surgical procedure kits due to inability to confirm sterilization assurance. An internal investigation found that certain components may not have been properly sterilized.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB; 3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O; 4) OFF PUMP CABG PACK - 170316, M
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2420-2025·2025-09-03
Corin Operating Tables recalled due to electromagnetic interference risk
Corin Operating Tables (6 models) may become unresponsive to commands when used with high-frequency surgical equipment. The issue affects 315 units in the US and worldwide locations.
Product
Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2468-2025·2025-09-03
Medical procedure kits recalled for unconfirmed sterilization assurance
American Contract Systems is recalling surgical procedure kits (cranial and shunt packs) because the manufacturer cannot confirm that sterilization assurance requirements were met for certain components.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2422-2025·2025-09-03
Dental Atlantis IO FLO-S prosthetic device recalled for thread engagement defect
The Atlantis IO FLO-S dental prosthetic device has a thread engagement defect that prevents proper fitting with implants. Affected units may not seat correctly, potentially compromising prosthetic accuracy and function.
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
HighFDA (Devices)·Z-2416-2025·2025-09-03
Phototherapy Device Canopy May Detach Due to Weld Failure
THOR NovoTHOR phototherapy devices (Model S2188) may have a failed welded nut causing the canopy gas strut to detach, making the canopy difficult to lift. Eighty units have been recalled.
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
HighFDA (Devices)·Z-2445-2025·2025-09-03
Orascoptic Phantom Nose Pad Kits Recalled for Nickel Allergy Risk
Orascoptic nose pad kits may contain nickel that could cause allergic reactions. The affected kits were manufactured between June 2023 and May 2025 and distributed nationwide and internationally.
Product
Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2425-2025·2025-09-03
Onkos Surgical Recalls Stem Extension Implants Over Unidentified Substance
Onkos Surgical is recalling 554 ELEOS stem extension implants because an unidentified substance was found on the devices during retrospective testing. No illnesses or injuries have been reported.
Product
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2479-2025·2025-09-03
Medline Surgical Kits Recalled for Incorrect Foley Tray Information
Medline surgical kits containing BD SureStep Foley Tray Systems have been recalled due to incorrect product information insert sheets that could lead to patient injury, including infection or allergic reaction.
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-2442-2025·2025-09-03
Surgical Loupes with Nickel-Containing Nose Pads Recalled for Allergic Reaction Risk
Orascoptic Surgical Acuity is recalling Dragonfly Essentials Kits because the nose pads may contain nickel, which can cause allergic reactions in people with nickel sensitivity.
Product
Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2421-2025·2025-09-03
Dental Prosthetics Device Atlantis IO FLO-S Recalled for Thread Engagement Defect
The Atlantis IO FLO-S dental prosthetics device has a defect preventing proper thread engagement with dental implants. Threads engage only about 2 rotations instead of the required 5, resulting in approximately 1mm less depth of engagement.
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
HighFDA (Devices)·Z-2417-2025·2025-09-03
THOR NovoTHOR XL Heating Device Recalled for Canopy Detachment Risk
THOR is recalling 55 NovoTHOR XL heating devices due to potential failure of the welded nut securing the gas strut. If the nut shears, the canopy may become difficult to lift.
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
HighFDA (Devices)·Z-2342-2025·2025-09-03
GE HealthCare OEC C-arm Systems recalled for missing radiation shielding
GE HealthCare is recalling certain OEC 9800 and OEC 9900 Elite C-arm Systems due to missing lead tape in collimator covers, which increases radiation exposure to patients and operators.
Product
GE HealthCare OEC 9900 Elite C-arm Systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2439-2025·2025-09-03
TherMax Blood Warmer Unit may fail to detect blood bags correctly
The TherMax Blood Warmer Unit may not detect when a blood bag is present, making it difficult to set up therapy. Approximately 7,432 units are affected, distributed worldwide.
Product
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
Category
Medical Device
Distribution
0 states

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