Fresh Recalls

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

Medline Convenience Kits recall — Medline Industries, LP

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

Medline Convenience Kits recall — Medline Industries, LP

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

Medline Convenience Kits recall — Medline Industries, LP

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

Medline Convenience Kits recall — Medline Industries, LP

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

Medline Convenience Kits recall — Medline Industries, LP

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

Medline Convenience Kits recall — Medline Industries, LP

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

Medline Convenience Kits recall — Medline Industries, LP

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

STA Staclot Protein S recall — Diagnostica Stago, Inc.

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

Halyard medical convenience kits labeled as recall — AVID Medical, Inc.

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

1) NEURO recall — AVID Medical, Inc.

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

Halyard medical convenience kits labeled as recall — AVID Medical, Inc.

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 Brilliance CT 64 recall — Philips North America Llc

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 Ingenuity CT Product Codes recall — Philips North America Llc

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 IQon Spectral CT Product Codes recall — Philips North America Llc

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 Brilliance recall — Philips North America Llc

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

FRU (Field replaceable unit) recall — GE Medical Systems Information Technologies Inc

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

PORTRAIT CORE SERVICES SOFTWARE V1 recall — GE Medical Systems Information Technologies Inc

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

PORTRAIT COMPUTE AND CORE SERVICES V1 recall — GE Medical Systems Information Technologies Inc

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

PORTRAIT CORE SERVICES SOFTWARE V1 recall — GE Medical Systems Information Technologies Inc

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

POWERSEAL 5 MM (in diameter) 23 CM (long) recall — Olympus Corporation of the Americas

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

ORT300 recall — IMRIS Imaging Inc

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

ORT200 recall — IMRIS Imaging Inc

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

healthmark ProChek-W Protein Test for Robotic Arms recall — Healthmark Industries Co., Inc.

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

healthmark ProChek-II recall — Healthmark Industries Co., Inc.

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

FUJIFILM Synapse PACS software v7 recall — FUJIFILM Healthcare Americas Corporation

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

Medline convenience kits labeled as recall — Medline Industries, LP

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

Medline convenience kits labeled as recall — Medline Industries, LP

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

Medline convenience kits labeled as recall — Medline Industries, LP

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

Medline convenience kits labeled as recall — Medline Industries, LP

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

Medline convenience kits labeled as recall — Medline Industries, LP

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

Medline convenience kits labeled as recall — Medline Industries, LP

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

Medline convenience kits labeled as recall — Medline Industries, LP

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

Medline convenience kits labeled as recall — Medline Industries, LP

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

Medline convenience kits labeled as recall — Medline Industries, LP

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

Medline convenience kits labeled as recall — Medline Industries, LP

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

Medline convenience kits labeled as recall — Medline Industries, LP

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

CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5 recall — ConMed Corporation

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 recall — Fresenius Medical Care Renal Therapies Group, LLC

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

Grandio Universal Nano-Hybrid Restorative Material - Capsules 0 recall — Henry Schein Inc.

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

Structur 2 SC Temporary Resin Cartridge Refill 75Gm recall — Henry Schein Inc.

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

Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluo recall — Canon Medical System, USA, INC.

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

Midmark Digital ECG HD+12 recall — Midmark Corporation

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

Midmark IQecg Digital ECG recall — Midmark Corporation

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

Halyard TOTAL JOINT Model/Catalog Number recall — AVID Medical, Inc.

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

Halyard TOTAL JOINT Model/Catalog Number recall — AVID Medical, Inc.

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

Halyard TOTAL JOINT Model/Catalog Number recall — AVID Medical, Inc.

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

Halyard TOTAL JOINT Model/Catalog Number recall — AVID Medical, Inc.

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

Halyard TOTAL JOINT Model/Catalog Number recall — AVID Medical, Inc.

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

Halyard TOTAL JOINT Model/Catalog Number recall — AVID Medical, Inc.

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

Brand Name recall — AVID Medical, Inc.

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

Merge PACS and Merge OrthoPACS recall — Merge Healthcare, Inc.

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

American Contract System Convenience Kit recall — American Contract Systems Inc

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

American Contract System Convenience Kits recall — American Contract Systems Inc

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

American Contract System Convenience Kit recall — American Contract Systems Inc

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

American Contract System Convenience Kit recall — American Contract Systems Inc

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

Medline medical convenience kit labeled as recall — Medline Industries, LP

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

Onli 17cm Hydrophilic Urethral Intermittent Catheter recall — Hollister Ulc

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

Medline medical convenience kits recall — Medline Industries, LP

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

Medline medical convenience kits recall — Medline Industries, LP

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

Medline medical convenience kits recall — Medline Industries, LP

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

Medline medical convenience kits recall — Medline Industries, LP

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

Medline breathing circuits labeled as recall — Medline Industries, LP

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

Medline breathing circuits labeled as recall — Medline Industries, LP

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

Medline Hudson RCI recall — Medline Industries, LP

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

Philips Incisive CT with software V4 recall — Philips Healthcare (Suzhou) Co., Ltd.

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

American Contract Systems medical procedure kits and trays labeled as recall — American Contract Systems Inc

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

American Contract Systems medical procedure kits and trays labeled as recall — American Contract Systems Inc

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

Brand Name recall — restor3d Inc.

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

Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers recall — ConvaTec, Inc

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

Fort Defiance Industries (FDI) recall — Fort Defiance Industries, LLC

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

MiniMed 780G Insulin Pump recall — Medtronic MiniMed, Inc.

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

MiniMed 670G Insulin Pump recall — Medtronic MiniMed, Inc.

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

MiniMed 640G Insulin Pump recall — Medtronic MiniMed, Inc.

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

BMC/REACTHEALTH Luna G3 APAP REF LG 3600 recall — BMC Medical Co., Ltd.

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

Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus recall — Boston Scientific Corporation

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

Boston Scientific ENROUTE Transcarotid Neuroprotection System recall — Boston Scientific Corporation

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

Beckman Coulter recall — Siemens Healthcare Diagnostics, Inc.

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

Syva EMIT 2000 Quinidine Assay REF recall — Siemens Healthcare Diagnostics, Inc.

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

Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1 recall — Beckman Coulter Inc.

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

Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1 recall — Beckman Coulter Inc.

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

Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A recall — Paragon 28, Inc.

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

Custom Made Device Implant 6123 Navicular Cage Small Right Rev A recall — Paragon 28, Inc.

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

Blanketrol III recall — Gentherm Medical, LLC

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

Innercool Coolblue Console recall — Gentherm Medical, LLC

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

Blanketrol II Model 222S recall — Gentherm Medical, LLC

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

Paragonix Technologies Inc recall — Paragonix Technologies Inc.

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

Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s) recall — Siemens Healthcare Diagnostics Products Ltd.

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

Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF recall — Siemens Healthcare Diagnostics Products Ltd.

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

Halyard LAVH PACK recall — AVID Medical, Inc.

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

GETINGE Y SENSOR Module recall — Maquet Critical Care AB

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

Suture Cinch Long 1pk recall — Boston Scientific Corporation

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

OverStitch Suture Cinch recall — Boston Scientific Corporation

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

TD Navio Maxi Speech Generating Device Model/Catalog Number recall — Tobii Dynavox Llc

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

TD Navio Midi Speech Generating Device Model/Catalog Number recall — Tobii Dynavox Llc

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

Arrow-LOK Implant recall — Arrowhead DE LLC

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

Brand Name recall — Kico Knee Innovation Company

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

Cardiac Workstation 7000 recall — Philips North America Llc

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

Cardiac Workstation 5000 recall — Philips North America Llc

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

Dentsply Sirona Capsule Mixer Model No recall — SDI Limited

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

One-Piece Guedel Airway recall — Intersurgical Inc

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

One-Piece Guedel Airway recall — Intersurgical Inc

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

Hamilton Microlab STAR Liquid Handler recall — Foundation Medicine, Inc.

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

EndoFLIP System that includes recall — Covidien, LLC

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

Ami HTX recall — Spectral Instruments Inc

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

Lago X recall — Spectral Instruments Inc

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

BD Needle Kit for Powered Driver 15mm x 15Ga recall — Bard Access Systems, Inc.

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

Cardinal Health Presource Kits recall — Cardinal Health 200, LLC

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

Cardinal Health Presource Kits recall — Cardinal Health 200, LLC

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

Cardinal Health Presource Kits recall — Cardinal Health 200, LLC

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

Cardinal Health Presource Kits recall — Cardinal Health 200, LLC

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

Cardinal Health Presource Kits recall — Cardinal Health 200, LLC

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

Cardinal Health Presource Kits recall — Cardinal Health 200, LLC

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

Cardinal Health Presource Kits recall — Cardinal Health 200, LLC

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

Cardinal Health Presource Kits recall — Cardinal Health 200, LLC

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

60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code recall — BD SWITZERLAND SARL

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

ERBECRYO 2 Cryosurgical Unit Model/Catalog Number recall — Erbe USA Inc

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

ProNephro AKI (NGAL) Reagent Kit (100 tests) recall — Bioporto Diagnostics A/S

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

BIOFIRE Respiratory Panel 2 recall — BioFire Diagnostics, LLC

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

Straumann Bone Level Tapered (BLT) Implant recall — Straumann USA LLC

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

Endo-Model recall — Waldemar Link GmbH & Co. KG (Mfg Site)

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

OBP Medical recall — OBP Medical Corporation

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

Philips Azurion recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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

Philips Azurion Rystem recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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

GLIDESHEATH SLENDER A-KIT 6F 10CM recall — Terumo Medical Corporation

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

GM Helix Implant recall — Straumann USA LLC

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

Allura Xper FD recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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

Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL recall — Remel Europe Ltd.

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 recall — Medline Industries, LP

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 recall — Medline Industries, LP

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 recall — Medline Industries, LP

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 recall — Medline Industries, LP

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

Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX recall — Covidien, LP

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

Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623 recall — Covidien, LP

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

Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU recall — Covidien, LP

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

V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY P recall — Covidien, LP

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

V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 G recall — Covidien, LP

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

Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF recall — Galt Medical Corporation

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

Brand Name recall — Spacelabs Healthcare, Inc.

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

GORE VIABIL Short Wire Biliary Endoprosthesis recall — W L Gore & Associates, Inc.

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

GORE VIABIL Short Wire Biliary Endoprosthesis recall — W L Gore & Associates, Inc.

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

navify Digital Pathology (on-prem) v2 recall — Ventana Medical Systems, Inc.

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

BOBBY Balloon Guide Catheter REF recall — MICROVENTION INC.

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

Brand Name recall — Spectra Medical Devices, Llc

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 Duo-Vent Solution Set and Male Luer Lock Adapter recall — Baxter Healthcare Corporation

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

Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embol recall — Contego Medical, Inc

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

Blom-Singer Classic Indwelling Voice Prosthesis recall — Freudenberg Medical, LLC

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

Blom-Singer Classic Indwelling Voice Prosthesis recall — Freudenberg Medical, LLC

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

Brand Name recall — TISSIUM SA

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

Brand Name recall — TISSIUM SA

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

Brand Name recall — TISSIUM SA

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

Brand Name recall — TISSIUM SA

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

Brand Name recall — TISSIUM SA

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

Brand Name recall — TISSIUM SA

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

Brand Name recall — TISSIUM SA

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

Brand Name recall — TISSIUM SA

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

GEM Premier 5000 PAK Part Numbers recall — Instrumentation Laboratory

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

GEM Premier 7000 with iQM3 Part Numbers recall — Instrumentation Laboratory

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

Brand Name recall — United Orthopedic Corp.

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

Brand Name recall — United Orthopedic Corp.

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

5-PLASMA Bivalirudin Control recall — Aniara Diagnostica LLC

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

5-PLASMA Bivalirudin Calibrator recall — Aniara Diagnostica LLC

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

5-PLASMA Bivalirudin AMR Verification Kit recall — Aniara Diagnostica LLC

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

Philips Allura recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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

Philips Azurion under the following System Descriptions and corresponding model numbers recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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

Philips Allura under the following System Descriptions and corresponding model numbers recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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

Atellica CH Urine Albumin REF recall — Siemens Healthcare Diagnostics, Inc.

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

REF # D23354 recall — Beckman Coulter Inc.

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

REF # D23352 recall — Beckman Coulter Inc.

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

HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) fo recall — Hardy Diagnostics

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

Brand Name recall — United Orthopedic Corp.

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

Brand Name recall — United Orthopedic Corp.

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

Brand Name recall — United Orthopedic Corp.

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

Brand Name recall — United Orthopedic Corp.

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

Happiest Baby recall — Happiest Baby, Inc

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

Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No recall — Siemens Healthcare Diagnostics, Inc.

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

Syva Emit Disopyramide Assay Enzyme Immunoassay recall — Siemens Healthcare Diagnostics, Inc.

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

INFINION CX LEAD KIT recall — Boston Scientific Neuromodulation Corporation

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

GE Healthcare Portrait Core Services SW V 1 recall — GE Medical Systems Information Technologies Inc

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

FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code recall — Biofire Defense

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

GE Healthcare MAC VU360 recall — GE Medical Systems Information Technologies Inc

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

Merge OrthoPACS recall — Merge Healthcare, Inc.

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

Merge PACS recall — Merge Healthcare, Inc.

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

Intramedullary Bone Saw Blade Assembly Model/Catalog Number recall — Biomet, Inc.

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

Intramedullary Bone Saw Blade Assembly Model/Catalog Number recall — Biomet, Inc.

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

Intramedullary Bone Saw Blade Assembly Model/Catalog Number recall — Biomet, Inc.

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

Intramedullary Bone Saw Blade Assembly Model/Catalog Number recall — Biomet, Inc.

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

Intramedullary Bone Saw Blade Assembly Model/Catalog Number recall — Biomet, Inc.

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

STRYKER PKG recall — Stryker Corporation

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

STRYKER PKG recall — Stryker Corporation

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

STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING recall — Stryker Corporation

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

STRYKER AHTO TUBE SET WITH TIP PACKAGING recall — Stryker Corporation

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

STRYKER AHTO TUBE SET PACKAGING recall — Stryker Corporation

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

Brand Name recall — Nuclein LLC

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

Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C2 recall — Maquet Critical Care AB

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

Anti-Torque recall — Innovasis, Inc

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

Brand Name recall — Medical Action Industries, Inc. 306

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

Brand Name recall — Oxos Medical Inc

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

munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smar recall — MUNEVO GMBH

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

Nerivio Infinity recall — THERANICA BIOELECTRONICS LTD

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

Brand Name recall — Copan WASP

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 ↗

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Sources last checked October 22, 2026 at 12:00 PM UTC.