Medical device recalls — page 3
1,617 recent medical device recalls in our current data.
Showing 401–600, newest first.
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-3054-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-3053-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-3052-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-3051-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-3050-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-3049-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-3048-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
Company / brand: Diagnostica Stago recalls
Affected product: STA Staclot Protein S recall status
Official ID Z-3047-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 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 55998…
Company / brand: AVID Medical recalls
Affected product: Halyard medical convenience kits labeled as recall status
Official ID Z-3046-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 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 55998…
Company / brand: AVID Medical recalls
Affected product: 1) NEURO recall status
Official ID Z-3045-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 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 55998…
Company / brand: AVID Medical recalls
Affected product: Halyard medical convenience kits labeled as recall status
Official ID Z-3044-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
Company / brand: Philips North America recalls
Affected product: Philips Brilliance CT 64 recall status
Official ID Z-3043-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
Company / brand: Philips North America recalls
Affected product: Philips Ingenuity CT Product Codes recall status
Official ID Z-3042-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
Company / brand: Philips North America recalls
Affected product: Philips IQon Spectral CT Product Codes recall status
Official ID Z-3041-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
Company / brand: Philips North America recalls
Affected product: Philips Brilliance recall status
Official ID Z-3040-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and…
Company / brand: GE Medical Systems Information Technologies recalls
Affected product: FRU (Field replaceable unit) recall status
Official ID Z-3039-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and…
Company / brand: GE Medical Systems Information Technologies recalls
Affected product: PORTRAIT CORE SERVICES SOFTWARE V1 recall status
Official ID Z-3038-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and…
Company / brand: GE Medical Systems Information Technologies recalls
Affected product: PORTRAIT COMPUTE AND CORE SERVICES V1 recall status
Official ID Z-3037-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and…
Company / brand: GE Medical Systems Information Technologies recalls
Affected product: PORTRAIT CORE SERVICES SOFTWARE V1 recall status
Official ID Z-3036-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Company / brand: Olympus of the Americas recalls
Affected product: POWERSEAL 5 MM (in diameter) 23 CM (long) recall status
Official ID Z-3035-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This…
Company / brand: IMRIS Imaging recalls
Affected product: ORT300 recall status
Official ID Z-3034-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This…
Company / brand: IMRIS Imaging recalls
Affected product: ORT200 recall status
Official ID Z-3033-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Test manufactured with an expired ingredient which may present as either a false negative or positive.
Company / brand: Healthmark Industries Co recalls
Affected product: healthmark ProChek-W Protein Test for Robotic Arms recall status
Official ID Z-3032-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Test manufactured with an expired ingredient which may present as either a false negative or positive.
Company / brand: Healthmark Industries Co recalls
Affected product: healthmark ProChek-II recall status
Official ID Z-3031-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Software issue may cause the ruler measurement to be inaccurate.
Company / brand: FUJIFILM Healthcare Americas recalls
Affected product: FUJIFILM Synapse PACS software v7 recall status
Official ID Z-3030-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Kits contain a potentially contaminated component which were recalled by the manufacturer
Company / brand: Medline Industries recalls
Affected product: Medline convenience kits labeled as recall status
Official ID Z-3029-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Kits contain a potentially contaminated component which were recalled by the manufacturer
Company / brand: Medline Industries recalls
Affected product: Medline convenience kits labeled as recall status
Official ID Z-3028-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Kits contain a potentially contaminated component which were recalled by the manufacturer
Company / brand: Medline Industries recalls
Affected product: Medline convenience kits labeled as recall status
Official ID Z-3027-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Kits contain a potentially contaminated component which were recalled by the manufacturer
Company / brand: Medline Industries recalls
Affected product: Medline convenience kits labeled as recall status
Official ID Z-3026-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Kits contain a potentially contaminated component which were recalled by the manufacturer
Company / brand: Medline Industries recalls
Affected product: Medline convenience kits labeled as recall status
Official ID Z-3025-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Kits contain a potentially contaminated component which were recalled by the manufacturer
Company / brand: Medline Industries recalls
Affected product: Medline convenience kits labeled as recall status
Official ID Z-3024-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Kits contain a potentially contaminated component which were recalled by the manufacturer
Company / brand: Medline Industries recalls
Affected product: Medline convenience kits labeled as recall status
Official ID Z-3023-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Kits contain a potentially contaminated component which were recalled by the manufacturer
Company / brand: Medline Industries recalls
Affected product: Medline convenience kits labeled as recall status
Official ID Z-3022-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Kits contain a potentially contaminated component which were recalled by the manufacturer
Company / brand: Medline Industries recalls
Affected product: Medline convenience kits labeled as recall status
Official ID Z-3021-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Kits contain a potentially contaminated component which were recalled by the manufacturer
Company / brand: Medline Industries recalls
Affected product: Medline convenience kits labeled as recall status
Official ID Z-3020-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Kits contain a potentially contaminated component which were recalled by the manufacturer
Company / brand: Medline Industries recalls
Affected product: Medline convenience kits labeled as recall status
Official ID Z-3019-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.
Company / brand: ConMed recalls
Affected product: CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5 recall status
Official ID Z-3018-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis m…
Company / brand: Fresenius Medical Care Renal Therapies Group recalls
Affected product: Fresenius Medical Care recall status
Official ID Z-3017-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
Company / brand: Henry Schein recalls
Affected product: Grandio Universal Nano-Hybrid Restorative Material - Capsules 0 recall status
Official ID Z-3016-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
Company / brand: Henry Schein recalls
Affected product: Structur 2 SC Temporary Resin Cartridge Refill 75Gm recall status
Official ID Z-3015-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.
Company / brand: Canon Medical System recalls
Affected product: Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluo recall status
Official ID Z-3014-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
Company / brand: Midmark recalls
Affected product: Midmark Digital ECG HD+12 recall status
Official ID Z-3013-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
Company / brand: Midmark recalls
Affected product: Midmark IQecg Digital ECG recall status
Official ID Z-3012-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Company / brand: AVID Medical recalls
Affected product: Halyard TOTAL JOINT Model/Catalog Number recall status
Official ID Z-3011-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Company / brand: AVID Medical recalls
Affected product: Halyard TOTAL JOINT Model/Catalog Number recall status
Official ID Z-3010-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Company / brand: AVID Medical recalls
Affected product: Halyard TOTAL JOINT Model/Catalog Number recall status
Official ID Z-3009-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Company / brand: AVID Medical recalls
Affected product: Halyard TOTAL JOINT Model/Catalog Number recall status
Official ID Z-3008-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Company / brand: AVID Medical recalls
Affected product: Halyard TOTAL JOINT Model/Catalog Number recall status
Official ID Z-3007-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Company / brand: AVID Medical recalls
Affected product: Halyard TOTAL JOINT Model/Catalog Number recall status
Official ID Z-3006-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Company / brand: AVID Medical recalls
Affected product: Brand Name recall status
Official ID Z-3005-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Software issue may cause measurements to be displayed inaccurately.
Company / brand: Merge Healthcare recalls
Affected product: Merge PACS and Merge OrthoPACS recall status
Official ID Z-3004-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representativ…
Company / brand: American Contract Systems recalls
Affected product: American Contract System Convenience Kit recall status
Official ID Z-3003-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representativ…
Company / brand: American Contract Systems recalls
Affected product: American Contract System Convenience Kits recall status
Official ID Z-3002-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representativ…
Company / brand: American Contract Systems recalls
Affected product: American Contract System Convenience Kit recall status
Official ID Z-3001-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representativ…
Company / brand: American Contract Systems recalls
Affected product: American Contract System Convenience Kit recall status
Official ID Z-3000-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Component labeling discrepancy
Company / brand: Medline Industries recalls
Affected product: Medline medical convenience kit labeled as recall status
Official ID Z-2999-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary…
Company / brand: Hollister Ulc recalls
Affected product: Onli 17cm Hydrophilic Urethral Intermittent Catheter recall status
Official ID Z-2998-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification lev…
Company / brand: Medline Industries recalls
Affected product: Medline medical convenience kits recall status
Official ID Z-2997-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification lev…
Company / brand: Medline Industries recalls
Affected product: Medline medical convenience kits recall status
Official ID Z-2996-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification lev…
Company / brand: Medline Industries recalls
Affected product: Medline medical convenience kits recall status
Official ID Z-2995-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification lev…
Company / brand: Medline Industries recalls
Affected product: Medline medical convenience kits recall status
Official ID Z-2994-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke,…
Company / brand: Medline Industries recalls
Affected product: Medline breathing circuits labeled as recall status
Official ID Z-2993-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke,…
Company / brand: Medline Industries recalls
Affected product: Medline breathing circuits labeled as recall status
Official ID Z-2992-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke,…
Company / brand: Medline Industries recalls
Affected product: Medline Hudson RCI recall status
Official ID Z-2991-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Potential of failing to trigger clinical scan during Bolus Tracking.
Company / brand: Philips Healthcare (Suzhou) Co recalls
Affected product: Philips Incisive CT with software V4 recall status
Official ID Z-2988-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 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 55998…
Company / brand: American Contract Systems recalls
Affected product: American Contract Systems medical procedure kits and trays labeled as recall status
Official ID Z-2990-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 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 55998…
Company / brand: American Contract Systems recalls
Affected product: American Contract Systems medical procedure kits and trays labeled as recall status
Official ID Z-2989-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
Company / brand: restor3d recalls
Affected product: Brand Name recall status
Official ID Z-2987-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Urostomy Pouches may leak from cap during use.
Company / brand: ConvaTec recalls
Affected product: Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers recall status
Official ID Z-2986-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 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 f…
Company / brand: Fort Defiance Industries recalls
Affected product: Fort Defiance Industries (FDI) recall status
Official ID Z-2983-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 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 u…
Company / brand: Medtronic MiniMed recalls
Affected product: MiniMed 780G Insulin Pump recall status
Official ID Z-2982-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 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 u…
Company / brand: Medtronic MiniMed recalls
Affected product: MiniMed 670G Insulin Pump recall status
Official ID Z-2981-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 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 u…
Company / brand: Medtronic MiniMed recalls
Affected product: MiniMed 640G Insulin Pump recall status
Official ID Z-2980-2026 ·
Official record ↗
FDA Class I · Medical device · August 26, 2026
Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse
Company / brand: BMC Medical Co recalls
Affected product: BMC/REACTHEALTH Luna G3 APAP REF LG 3600 recall status
Official ID Z-2979-2026 ·
Official record ↗
FDA Class I · Medical device · August 26, 2026
Potential for arterial sheath tip separation or partial tip separation during use.
Company / brand: Boston Scientific recalls
Affected product: Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus recall status
Official ID Z-2978-2026 ·
Official record ↗
FDA Class I · Medical device · August 26, 2026
Potential for arterial sheath tip separation or partial tip separation during use.
Company / brand: Boston Scientific recalls
Affected product: Boston Scientific ENROUTE Transcarotid Neuroprotection System recall status
Official ID Z-2977-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk o…
Company / brand: Siemens Healthcare Diagnostics recalls
Affected product: Beckman Coulter recall status
Official ID Z-2976-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk o…
Company / brand: Siemens Healthcare Diagnostics recalls
Affected product: Syva EMIT 2000 Quinidine Assay REF recall status
Official ID Z-2975-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 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 …
Company / brand: Beckman Coulter recalls
Affected product: Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1 recall status
Official ID Z-2974-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 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 …
Company / brand: Beckman Coulter recalls
Affected product: Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1 recall status
Official ID Z-2973-2026 ·
Official record ↗
FDA Class III · Medical device · August 26, 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.
Company / brand: Paragon 28 recalls
Affected product: Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A recall status
Official ID Z-2972-2026 ·
Official record ↗
FDA Class III · Medical device · August 26, 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.
Company / brand: Paragon 28 recalls
Affected product: Custom Made Device Implant 6123 Navicular Cage Small Right Rev A recall status
Official ID Z-2971-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Overheating of the 115V CPU board may cause the device to shut down.
Company / brand: Gentherm Medical recalls
Affected product: Blanketrol III recall status
Official ID Z-2970-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Overheating of the 115V CPU board may cause the device to shut down.
Company / brand: Gentherm Medical recalls
Affected product: Innercool Coolblue Console recall status
Official ID Z-2969-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Overheating of the 115V CPU board may cause the device to shut down.
Company / brand: Gentherm Medical recalls
Affected product: Blanketrol II Model 222S recall status
Official ID Z-2968-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.
Company / brand: Paragonix Technologies recalls
Affected product: Paragonix Technologies Inc recall status
Official ID Z-2967-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Company / brand: Siemens Healthcare Diagnostics Products recalls
Affected product: Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s) recall status
Official ID Z-2966-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Company / brand: Siemens Healthcare Diagnostics Products recalls
Affected product: Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF recall status
Official ID Z-2965-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
Company / brand: AVID Medical recalls
Affected product: Halyard LAVH PACK recall status
Official ID Z-2964-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
The module did not undergo electrical safety tests and functional tests during production.
Company / brand: Maquet Critical Care AB recalls
Affected product: GETINGE Y SENSOR Module recall status
Official ID Z-2963-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Company / brand: Boston Scientific recalls
Affected product: Suture Cinch Long 1pk recall status
Official ID Z-2962-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Company / brand: Boston Scientific recalls
Affected product: OverStitch Suture Cinch recall status
Official ID Z-2961-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 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. …
Company / brand: Tobii Dynavox recalls
Affected product: TD Navio Maxi Speech Generating Device Model/Catalog Number recall status
Official ID Z-2960-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 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. …
Company / brand: Tobii Dynavox recalls
Affected product: TD Navio Midi Speech Generating Device Model/Catalog Number recall status
Official ID Z-2959-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
Company / brand: Arrowhead DE recalls
Affected product: Arrow-LOK Implant recall status
Official ID Z-2958-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing
Company / brand: Kico Knee Innovation Company recalls
Affected product: Brand Name recall status
Official ID Z-2957-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Device will intermittently provide inaccurate data related to native heart rate.
Company / brand: Philips North America recalls
Affected product: Cardiac Workstation 7000 recall status
Official ID Z-2956-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Device will intermittently provide inaccurate data related to native heart rate.
Company / brand: Philips North America recalls
Affected product: Cardiac Workstation 5000 recall status
Official ID Z-2955-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Potential for electrical discharge from unit when unplugged.
Company / brand: SDI recalls
Affected product: Dentsply Sirona Capsule Mixer Model No recall status
Official ID Z-2954-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Devices could potentially be occluded or partially occluded.
Company / brand: Intersurgical recalls
Affected product: One-Piece Guedel Airway recall status
Official ID Z-2953-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Devices could potentially be occluded or partially occluded.
Company / brand: Intersurgical recalls
Affected product: One-Piece Guedel Airway recall status
Official ID Z-2952-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Software issue that can cause an increase in spontaneous software closures.
Company / brand: Foundation Medicine recalls
Affected product: Hamilton Microlab STAR Liquid Handler recall status
Official ID Z-2951-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.
Company / brand: Covidien recalls
Affected product: EndoFLIP System that includes recall status
Official ID Z-2950-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
Company / brand: Spectral Instruments recalls
Affected product: Ami HTX recall status
Official ID Z-2940-2026 ·
Official record ↗
FDA Class II · Medical device · August 26, 2026
Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
Company / brand: Spectral Instruments recalls
Affected product: Lago X recall status
Official ID Z-2939-2026 ·
Official record ↗
FDA Class I · Medical device · August 26, 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 exp…
Company / brand: Bard Access Systems recalls
Affected product: BD Needle Kit for Powered Driver 15mm x 15Ga recall status
Official ID Z-2872-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200 recalls
Affected product: Cardinal Health Presource Kits recall status
Official ID Z-2949-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200 recalls
Affected product: Cardinal Health Presource Kits recall status
Official ID Z-2948-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200 recalls
Affected product: Cardinal Health Presource Kits recall status
Official ID Z-2947-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200 recalls
Affected product: Cardinal Health Presource Kits recall status
Official ID Z-2946-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200 recalls
Affected product: Cardinal Health Presource Kits recall status
Official ID Z-2945-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200 recalls
Affected product: Cardinal Health Presource Kits recall status
Official ID Z-2944-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200 recalls
Affected product: Cardinal Health Presource Kits recall status
Official ID Z-2943-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200 recalls
Affected product: Cardinal Health Presource Kits recall status
Official ID Z-2942-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Products may not have received adequate sterilization processing.
Company / brand: BD SWITZERLAND SARL recalls
Affected product: 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code recall status
Official ID Z-2941-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the r…
Company / brand: Erbe USA recalls
Affected product: ERBECRYO 2 Cryosurgical Unit Model/Catalog Number recall status
Official ID Z-2938-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring o…
Company / brand: Bioporto Diagnostics A/S recalls
Affected product: ProNephro AKI (NGAL) Reagent Kit (100 tests) recall status
Official ID Z-2937-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Due to increase in false negative results
Company / brand: BioFire Diagnostics recalls
Affected product: BIOFIRE Respiratory Panel 2 recall status
Official ID Z-2936-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest…
Company / brand: Straumann USA recalls
Affected product: Straumann Bone Level Tapered (BLT) Implant recall status
Official ID Z-2935-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified s…
Company / brand: Waldemar Link & Co. KG (Mfg Site) recalls
Affected product: Endo-Model recall status
Official ID Z-2934-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the hea…
Company / brand: OBP Medical recalls
Affected product: OBP Medical recall status
Official ID Z-2933-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss…
Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V recalls
Affected product: Philips Azurion recall status
Official ID Z-2932-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropria…
Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V recalls
Affected product: Philips Azurion Rystem recall status
Official ID Z-2931-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
Company / brand: Terumo Medical recalls
Affected product: GLIDESHEATH SLENDER A-KIT 6F 10CM recall status
Official ID Z-2930-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the i…
Company / brand: Straumann USA recalls
Affected product: GM Helix Implant recall status
Official ID Z-2929-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Firmware issue potentially leading to loss of geometry movements.
Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V recalls
Affected product: Allura Xper FD recall status
Official ID Z-2928-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
Company / brand: Remel Europe recalls
Affected product: Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL recall status
Official ID Z-2927-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…
Company / brand: Medline Industries recalls
Affected product: Medline Micro-Kill Bleach Germicidal Bleach Wipes recall status
Official ID Z-2926-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…
Company / brand: Medline Industries recalls
Affected product: Medline Micro-Kill Bleach Germicidal Bleach Wipes recall status
Official ID Z-2925-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…
Company / brand: Medline Industries recalls
Affected product: Medline Micro-Kill Bleach Germicidal Bleach Wipes recall status
Official ID Z-2924-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…
Company / brand: Medline Industries recalls
Affected product: Medline Micro-Kill Bleach Germicidal Bleach Wipes recall status
Official ID Z-2923-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v…
Company / brand: Covidien recalls
Affected product: Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX recall status
Official ID Z-2922-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v…
Company / brand: Covidien recalls
Affected product: Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623 recall status
Official ID Z-2921-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v…
Company / brand: Covidien recalls
Affected product: Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU recall status
Official ID Z-2920-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v…
Company / brand: Covidien recalls
Affected product: V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY P recall status
Official ID Z-2919-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v…
Company / brand: Covidien recalls
Affected product: V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 G recall status
Official ID Z-2918-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
Company / brand: Galt Medical recalls
Affected product: Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF recall status
Official ID Z-2917-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Due to off-the-shelf display port component that has audio/video failures
Company / brand: Spacelabs Healthcare recalls
Affected product: Brand Name recall status
Official ID Z-2916-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
Company / brand: W L Gore & Associates recalls
Affected product: GORE VIABIL Short Wire Biliary Endoprosthesis recall status
Official ID Z-2915-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
Company / brand: W L Gore & Associates recalls
Affected product: GORE VIABIL Short Wire Biliary Endoprosthesis recall status
Official ID Z-2914-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
Company / brand: Ventana Medical Systems recalls
Affected product: navify Digital Pathology (on-prem) v2 recall status
Official ID Z-2913-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Due to an increase rate of balloon pinhole defects.
Company / brand: MICROVENTION recalls
Affected product: BOBBY Balloon Guide Catheter REF recall status
Official ID Z-2912-2026 ·
Official record ↗
FDA Class I · Medical device · August 19, 2026
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganism…
Company / brand: Spectra Medical Devices recalls
Affected product: Brand Name recall status
Official ID Z-2873-2026 ·
Official record ↗
FDA Class I · Medical device · August 19, 2026
Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.
Company / brand: Baxter Healthcare recalls
Affected product: Baxter Duo-Vent Solution Set and Male Luer Lock Adapter recall status
Official ID Z-2766-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open followi…
Company / brand: Contego Medical recalls
Affected product: Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embol recall status
Official ID Z-2911-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flang…
Company / brand: Freudenberg Medical recalls
Affected product: Blom-Singer Classic Indwelling Voice Prosthesis recall status
Official ID Z-2910-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flang…
Company / brand: Freudenberg Medical recalls
Affected product: Blom-Singer Classic Indwelling Voice Prosthesis recall status
Official ID Z-2909-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device …
Company / brand: TISSIUM SA recalls
Affected product: Brand Name recall status
Official ID Z-2908-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device …
Company / brand: TISSIUM SA recalls
Affected product: Brand Name recall status
Official ID Z-2907-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device …
Company / brand: TISSIUM SA recalls
Affected product: Brand Name recall status
Official ID Z-2906-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device …
Company / brand: TISSIUM SA recalls
Affected product: Brand Name recall status
Official ID Z-2905-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device …
Company / brand: TISSIUM SA recalls
Affected product: Brand Name recall status
Official ID Z-2904-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device …
Company / brand: TISSIUM SA recalls
Affected product: Brand Name recall status
Official ID Z-2903-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device …
Company / brand: TISSIUM SA recalls
Affected product: Brand Name recall status
Official ID Z-2902-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device …
Company / brand: TISSIUM SA recalls
Affected product: Brand Name recall status
Official ID Z-2901-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result…
Company / brand: Instrumentation Laboratory recalls
Affected product: GEM Premier 5000 PAK Part Numbers recall status
Official ID Z-2900-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunctio…
Company / brand: Instrumentation Laboratory recalls
Affected product: GEM Premier 7000 with iQM3 Part Numbers recall status
Official ID Z-2899-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Company / brand: United Orthopedic recalls
Affected product: Brand Name recall status
Official ID Z-2898-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Company / brand: United Orthopedic recalls
Affected product: Brand Name recall status
Official ID Z-2897-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin…
Company / brand: Aniara Diagnostica recalls
Affected product: 5-PLASMA Bivalirudin Control recall status
Official ID Z-2896-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin…
Company / brand: Aniara Diagnostica recalls
Affected product: 5-PLASMA Bivalirudin Calibrator recall status
Official ID Z-2895-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin…
Company / brand: Aniara Diagnostica recalls
Affected product: 5-PLASMA Bivalirudin AMR Verification Kit recall status
Official ID Z-2894-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V recalls
Affected product: Philips Allura recall status
Official ID Z-2893-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V recalls
Affected product: Philips Azurion under the following System Descriptions and corresponding model numbers recall status
Official ID Z-2892-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V recalls
Affected product: Philips Allura under the following System Descriptions and corresponding model numbers recall status
Official ID Z-2891-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH En…
Company / brand: Siemens Healthcare Diagnostics recalls
Affected product: Atellica CH Urine Albumin REF recall status
Official ID Z-2890-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
Company / brand: Beckman Coulter recalls
Affected product: REF # D23354 recall status
Official ID Z-2889-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
Company / brand: Beckman Coulter recalls
Affected product: REF # D23352 recall status
Official ID Z-2888-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an…
Company / brand: Hardy Diagnostics recalls
Affected product: HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) fo recall status
Official ID Z-2887-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Company / brand: United Orthopedic recalls
Affected product: Brand Name recall status
Official ID Z-2886-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Company / brand: United Orthopedic recalls
Affected product: Brand Name recall status
Official ID Z-2885-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Company / brand: United Orthopedic recalls
Affected product: Brand Name recall status
Official ID Z-2884-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Company / brand: United Orthopedic recalls
Affected product: Brand Name recall status
Official ID Z-2883-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
This recall is retroactively being reported. Refurbished bassinets failed to meet quality standards prior to distribution.
Company / brand: Happiest Baby recalls
Affected product: Happiest Baby recall status
Official ID Z-2882-2026 ·
Official record ↗
FDA Class III · Medical device · August 12, 2026
out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall h…
Company / brand: Siemens Healthcare Diagnostics recalls
Affected product: Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No recall status
Official ID Z-2881-2026 ·
Official record ↗
FDA Class III · Medical device · August 12, 2026
Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk t…
Company / brand: Siemens Healthcare Diagnostics recalls
Affected product: Syva Emit Disopyramide Assay Enzyme Immunoassay recall status
Official ID Z-2880-2026 ·
Official record ↗
FDA Class I · Medical device · August 12, 2026
Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate…
Company / brand: Boston Scientific Neuromodulation recalls
Affected product: INFINION CX LEAD KIT recall status
Official ID Z-2879-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or acc…
Company / brand: GE Medical Systems Information Technologies recalls
Affected product: GE Healthcare Portrait Core Services SW V 1 recall status
Official ID Z-2878-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic …
Company / brand: Biofire Defense recalls
Affected product: FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code recall status
Official ID Z-2877-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of i…
Company / brand: GE Medical Systems Information Technologies recalls
Affected product: GE Healthcare MAC VU360 recall status
Official ID Z-2876-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
Company / brand: Merge Healthcare recalls
Affected product: Merge OrthoPACS recall status
Official ID Z-2875-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
Company / brand: Merge Healthcare recalls
Affected product: Merge PACS recall status
Official ID Z-2874-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused…
Company / brand: Biomet recalls
Affected product: Intramedullary Bone Saw Blade Assembly Model/Catalog Number recall status
Official ID Z-2871-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused…
Company / brand: Biomet recalls
Affected product: Intramedullary Bone Saw Blade Assembly Model/Catalog Number recall status
Official ID Z-2870-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused…
Company / brand: Biomet recalls
Affected product: Intramedullary Bone Saw Blade Assembly Model/Catalog Number recall status
Official ID Z-2869-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused…
Company / brand: Biomet recalls
Affected product: Intramedullary Bone Saw Blade Assembly Model/Catalog Number recall status
Official ID Z-2868-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused…
Company / brand: Biomet recalls
Affected product: Intramedullary Bone Saw Blade Assembly Model/Catalog Number recall status
Official ID Z-2867-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Company / brand: Stryker recalls
Affected product: STRYKER PKG recall status
Official ID Z-2866-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Company / brand: Stryker recalls
Affected product: STRYKER PKG recall status
Official ID Z-2865-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Company / brand: Stryker recalls
Affected product: STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING recall status
Official ID Z-2864-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Company / brand: Stryker recalls
Affected product: STRYKER AHTO TUBE SET WITH TIP PACKAGING recall status
Official ID Z-2863-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Company / brand: Stryker recalls
Affected product: STRYKER AHTO TUBE SET PACKAGING recall status
Official ID Z-2862-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
Company / brand: Nuclein recalls
Affected product: Brand Name recall status
Official ID Z-2861-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient …
Company / brand: Maquet Critical Care AB recalls
Affected product: Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C2 recall status
Official ID Z-2860-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with unde…
Company / brand: Innovasis recalls
Affected product: Anti-Torque recall status
Official ID Z-2859-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.
Company / brand: Medical Action Industries recalls
Affected product: Brand Name recall status
Official ID Z-2858-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Due to a defective circuit board that overheats
Company / brand: Oxos Medical recalls
Affected product: Brand Name recall status
Official ID Z-2857-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs, the device may experience unexpected steering drift or imprecise control…
Company / brand: MUNEVO recalls
Affected product: munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smar recall status
Official ID Z-2856-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
Company / brand: THERANICA BIOELECTRONICS recalls
Affected product: Nerivio Infinity recall status
Official ID Z-2855-2026 ·
Official record ↗
FDA Class II · Medical device · August 12, 2026
Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.
Company / brand: Copan WASP recalls
Affected product: Brand Name recall status
Official ID Z-2854-2026 ·
Official record ↗
Sources last checked October 22, 2026 at 12:00 PM UTC.