Medical DeviceAug 26, 2026
SDI Dentsply Sirona Capsule Mixer Model No. 5546068 recall — FDA Z-2954-2026
Potential for electrical discharge from unit when unplugged.
Class IIFDA: OngoingSDI Limited
Recall records from August 2026
These records include useful source details for the selected month.
Medical DeviceAug 26, 2026
Maquet Critical Care AB GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662 recall — FDA Z-2963-2026
The module did not undergo electrical safety tests and functional tests during production.
Class IIFDA: OngoingMaquet Critical Care AB
Medical DeviceAug 26, 2026
Arrowhead DE Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530 recall — FDA Z-2958-2026
Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
Class IIFDA: OngoingArrowhead DE LLC
Medical DeviceAug 26, 2026
Tobii Dynavox TD Navio Maxi Speech Generating Device recall — FDA Z-2960-2026
Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may…
Class IIFDA: OngoingTobii Dynavox LLC
Medical DeviceAug 26, 2026
Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) recall — FDA Z-2973-2026
a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new…
Class IIFDA: OngoingBeckman Coulter Inc.
Medical DeviceAug 26, 2026
Gentherm Medical Innercool Coolblue Console, Model STx recall — FDA Z-2969-2026
Overheating of the 115V CPU board may cause the device to shut down.
Class IIFDA: OngoingGentherm Medical, LLC
Medical DeviceAug 26, 2026
Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131 recall — FDA Z-2983-2026
The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault…
Class IIFDA: OngoingFort Defiance Industries, LLC
Medical DeviceAug 26, 2026
Gentherm Medical Blanketrol III, Model 233 recall — FDA Z-2970-2026
Overheating of the 115V CPU board may cause the device to shut down.
Class IIFDA: OngoingGentherm Medical, LLC
Medical DeviceAug 26, 2026
Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) recall — FDA Z-2974-2026
a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new…
Class IIFDA: OngoingBeckman Coulter Inc.
Medical DeviceAug 26, 2026
Bard Access Systems BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle recall — FDA Z-2872-2026
After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience…
Class IFDA: OngoingBard Access Systems, Inc.
Medical DeviceAug 26, 2026
Medtronic MiniMed MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712 recall — FDA Z-2980-2026
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or…
Class IIFDA: OngoingMedtronic MiniMed, Inc.
Medical DeviceAug 26, 2026
Medtronic MiniMed MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782 recall — FDA Z-2981-2026
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or…
Class IIFDA: OngoingMedtronic MiniMed, Inc.
Medical DeviceAug 26, 2026
Paragon 28 Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog recall — FDA Z-2972-2026
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Class IIIFDA: OngoingParagon 28, Inc.
Medical DeviceAug 26, 2026
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD recall — FDA Z-2965-2026
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Class IIFDA: OngoingSiemens Healthcare Diagnostics Products Ltd.
Medical DeviceAug 26, 2026
ConvaTec Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704 recall — FDA Z-2986-2026
Urostomy Pouches may leak from cap during use.
Class IIFDA: OngoingConvaTec, Inc.
Medical DeviceAug 26, 2026
Philips Cardiac Workstation 7000 recall — FDA Z-2956-2026
Device will intermittently provide inaccurate data related to native heart rate.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceAug 26, 2026
Covidien EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 recall — FDA Z-2950-2026
The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.
Class IIFDA: OngoingCovidien, LLC
Medical DeviceAug 26, 2026
Paragon 28 Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog recall — FDA Z-2971-2026
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Class IIIFDA: OngoingParagon 28, Inc.
Medical DeviceAug 26, 2026
Boston Scientific Suture Cinch Long 1pk recall — FDA Z-2962-2026
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceAug 26, 2026
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085 recall — FDA Z-2966-2026
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Class IIFDA: OngoingSiemens Healthcare Diagnostics Products Ltd.
Medical DeviceAug 26, 2026
Philips Cardiac Workstation 5000 recall — FDA Z-2955-2026
Device will intermittently provide inaccurate data related to native heart rate.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceAug 26, 2026
Medtronic MiniMed MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW recall — FDA Z-2982-2026
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or…
Class IIFDA: OngoingMedtronic MiniMed, Inc.
Medical DeviceAug 26, 2026
American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK recall — FDA Z-2989-2026
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to…
Class IIFDA: OngoingAmerican Contract Systems Inc.
Medical DeviceAug 26, 2026
Kico Knee Innovation ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 recall — FDA Z-2957-2026
Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing
Class IIFDA: OngoingKico Knee Innovation Company
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.