Medical DeviceSep 3, 2025
Diagnostica Stago STA-Liquid Anti-Xa 8 recall — FDA Z-2475-2025
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Class IIFDA: OngoingDiagnostica Stago, Inc.
September 2025 recalls — page 11
These records include useful source details for the selected month.
Medical DeviceSep 3, 2025
Medtronic Xomed IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834 recall — FDA Z-2461-2025
Due to out of the box wobble of the driver.
Class IIFDA: OngoingMedtronic Xomed, Inc.
Medical DeviceSep 3, 2025
Atlantis IO FLO-S Kit recall — FDA Z-2421-2025
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage approximately…
Class IIFDA: OngoingDentsply IH, Inc.
Medical DeviceSep 3, 2025
VANTIVE US HEALTHCARE TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes recall — FDA Z-2439-2025
Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not…
Class IIFDA: OngoingVANTIVE US HEALTHCARE LLC
Medical DeviceSep 3, 2025
Diagnostica Stago STA Satellite. Product Code: All references. All software versions. The recall — FDA Z-2473-2025
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Class IIFDA: OngoingDiagnostica Stago, Inc.
Medical DeviceSep 3, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT recall — FDA Z-2467-2025
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further…
Class IIFDA: OngoingAmerican Contract Systems Inc.
Medical DeviceSep 3, 2025
Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 recall — FDA Z-2444-2025
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Class IIFDA: OngoingOrascoptic Surgical Acuity
Medical DeviceSep 3, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK recall — FDA Z-2464-2025
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further…
Class IIFDA: OngoingAmerican Contract Systems Inc.
Medical DeviceSep 3, 2025
Diagnostica Stago STA-Liquid Anti-Xa 4 recall — FDA Z-2474-2025
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Class IIFDA: OngoingDiagnostica Stago, Inc.
Medical DeviceSep 3, 2025
Atlantis IO FLO-S Kit recall — FDA Z-2422-2025
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage approximately…
Class IIFDA: OngoingDentsply IH, Inc.
Medical DeviceSep 3, 2025
Bausch & Lomb Surgical Akreos, SKU: AO60P0300 recall — FDA Z-2451-2025
An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual…
Class IIIFDA: OngoingBausch & Lomb Surgical, Inc.
Medical DeviceSep 3, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK recall — FDA Z-2468-2025
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further…
Class IIFDA: OngoingAmerican Contract Systems Inc.
Medical DeviceSep 3, 2025
THOR NovoTHOR Gen 3.0 Reg PRX recall — FDA Z-2419-2025
The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
Class IIFDA: OngoingTHOR Photomedicine Ltd
Medical DeviceSep 3, 2025
Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. recall — FDA Z-2445-2025
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Class IIFDA: OngoingOrascoptic Surgical Acuity
Medical DeviceSep 3, 2025
GE Medical Systems GE HealthCare OEC 9800 recall — FDA Z-2341-2025
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceSep 3, 2025
Baxter Healthcare Spectrum IQ Infusion Pump, Product Code 3570009 recall — FDA Z-2415-2025
Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will…
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceSep 3, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL recall — FDA Z-2469-2025
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further…
Class IIFDA: OngoingAmerican Contract Systems Inc.
Medical DeviceSep 3, 2025
Medline ReNewal Reprocessed St recall — FDA Z-2460-2025
Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
Class IFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceSep 3, 2025
Tandem Diabetes Care Battery Operated infusion pumps. t:slim X2 G5, Replacement recall — FDA Z-2343-2025
Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing…
Class IFDA: OngoingTandem Diabetes Care, Inc.
Medical DeviceSep 3, 2025
HOMEDICS Air Compression Leg Massager recall — FDA Z-2463-2025
Regulatory documentation error and misleading color packaging claim.
Class IIFDA: OngoingZhejiang Luyao Electronics Technology Co., Ltd.
Medical DeviceSep 3, 2025
GE Medical Systems GE HealthCare OEC 9900 Elite C-arm Systems recall — FDA Z-2342-2025
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceSep 3, 2025
MEDLINE INDUSTRIES, LP - Northfield The Medline General Surgery Tray is customized to meet recall — FDA Z-2452-2025
Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange…
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceSep 3, 2025
MAQUET GMBH Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0 recall — FDA Z-2420-2025
Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur that could…
Class IIFDA: OngoingMAQUET GMBH
Medical DeviceSep 3, 2025
Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN recall — FDA Z-2479-2025
Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patient risk ranges from minor injury to…
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.