FDA Medical Device Recalls

Open, ClassifiedPosted Aug 20, 2026·Initiated Jul 9, 2026

Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter

Reason: Potential for arterial sheath tip separation or partial tip separation during use.

Root cause: Under Investigation by firm

Recalling firm: Boston Scientific CorporationType: Temporary Carotid Catheter For Embolic CaptureDistribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, JamaicaRecall #Z-2978-2026

Open, ClassifiedPosted Aug 20, 2026·Initiated May 19, 2026

American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item Number HSLM53AC; 3) CRANIAL PACK - 205992, Model Item Number MHCP75AH; 4) IMRI CRANI PACK - 213871, Model Item Number ANCI17AO; 5) CRANI PACK - 205942, Model Item Number ANCP30AP; 6) A-P PACK - 205936, Model Item Number ANAP22AP; 7) POSTERIOR PACK - 205960, Model Item Number ANPP15AR; 8) ANTERIOR CERVICAL PACK - 205935, Model Item Number ANAN51AI; 9) LAMINECTOMY PACK - 205957, Model Item Number ANLM40AG.

Reason: The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

Root cause: Nonconforming Material/Component

Recalling firm: American Contract Systems IncType: Neurological TrayDistribution: US distribution to states of: MN, MO, IARecall #Z-2989-2026

Open, ClassifiedPosted Aug 20, 2026·Initiated May 19, 2026

American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF.

Reason: The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

Root cause: Nonconforming Material/Component

Recalling firm: American Contract Systems IncType: Orthopedic TrayDistribution: US distribution to states of: MN, MO, IARecall #Z-2990-2026

Open, ClassifiedPosted Aug 19, 2026·Initiated Jul 15, 2026

BMC/REACTHEALTH Luna G3 APAP REF LG 3600

Reason: Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse

Root cause: No Marketing Application

Recalling firm: BMC Medical Co., Ltd.Type: Ventilator, Continuous, Non-Life-SupportingDistribution: US distribution to: FL OUS: NoneRecall #Z-2979-2026

Open, ClassifiedPosted Aug 19, 2026·Initiated Jul 6, 2026

Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 423725, 423726, 423727.

Reason: Urostomy Pouches may leak from cap during use.

Root cause: Material/Component Contamination

Recalling firm: ConvaTec, IncType: Bag, Urine Collecting, UreterostomyDistribution: US Nationwide distribution including in the states of AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA.Recall #Z-2986-2026

Open, ClassifiedPosted Aug 19, 2026·Initiated Jun 30, 2026

Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware product Product Description: The restor3d Reverse Total Shoulder Arthroplasty System is intended for patients requiring a reverse shoulder replacement for patients with a functional deltoid muscle and with a deficient rotator cuff. The restor3d Reverse Total Shoulder Arthroplasty System consists of the glenoid baseplate, glenosphere intraoperatively affixed to the baseplate, humeral stem, and polymer bearing component affixed to the humeral stem. Additionally, the system includes supporting standard instrument trays and all required accessories (e.g., security screws, peripheral screws). The restor3d rTSA System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The Veritas standard glenoid baseplate is the only component within scope of this field action. The patient-specific baseplate is unaffected by this defect and therefore not in scope. Component: Reverse Total Shoulder

Reason: Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.

Root cause: Device Design

Recalling firm: restor3d Inc.Type: Shoulder Prosthesis, Reverse ConfigurationDistribution: U.S. Nationwide distribution in the state of Texas.Recall #Z-2987-2026

Open, ClassifiedPosted Aug 18, 2026·Initiated Jul 13, 2026

MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;

Reason: 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 under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

Root cause: Process design

Recalling firm: Medtronic MiniMed, Inc.Type: Alternate Controller Enabled Insulin Infusion PumpDistribution: International distribution to the countries of Germany, Denmark, Austria, Netherlands, United Kingdom, Italy, Belgium, Ireland, Switzerland, Sweden, Northern Ireland.Recall #Z-2980-2026

Open, ClassifiedPosted Aug 18, 2026·Initiated Jul 13, 2026

MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;

Reason: 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 under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

Root cause: Process design

Recalling firm: Medtronic MiniMed, Inc.Type: Automated Insulin Dosing Device System, Single Hormonal ControlDistribution: International distribution to the countries of Germany, Denmark, Austria, Netherlands, United Kingdom, Italy, Belgium, Ireland, Switzerland, Sweden, Northern Ireland.Recall #Z-2981-2026

Open, ClassifiedPosted Aug 18, 2026·Initiated Jul 13, 2026

MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW

Reason: 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 under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

Root cause: Process design

Recalling firm: Medtronic MiniMed, Inc.Type: Alternate Controller Enabled Insulin Infusion PumpDistribution: International distribution to the countries of Germany, Denmark, Austria, Netherlands, United Kingdom, Italy, Belgium, Ireland, Switzerland, Sweden, Northern Ireland.Recall #Z-2982-2026

Open, ClassifiedPosted Aug 18, 2026·Initiated Jul 8, 2026

Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131

Reason: The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path.

Root cause: Component design/selection

Recalling firm: Fort Defiance Industries, LLCType: Sterilizer, SteamDistribution: Worldwide - US Nationwide distribution in the states of MD, VA, NJ, TN and the countries of Canada, Lithuania, Spain.Recall #Z-2983-2026

Open, ClassifiedPosted Aug 17, 2026·Initiated Jul 15, 2026

Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemistry Analyzers

Reason: a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.

Root cause: Software design (manufacturing process)

Recalling firm: Beckman Coulter Inc.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: Worldwide distribution - US Nationwide.Recall #Z-2973-2026

Open, ClassifiedPosted Aug 17, 2026·Initiated Jul 15, 2026

Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analyzers

Reason: a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.

Root cause: Software design (manufacturing process)

Recalling firm: Beckman Coulter Inc.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: Worldwide distribution - US Nationwide.Recall #Z-2974-2026

Open, ClassifiedPosted Aug 17, 2026·Initiated Jul 13, 2026

Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL

Reason: 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 of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.

Root cause: Unknown/Undetermined by firm

Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Enzyme Immunoassay, QuinidineDistribution: Worldwide - US Nationwide distribution in the state of CA and the country of Italy.Recall #Z-2975-2026

Open, ClassifiedPosted Aug 17, 2026·Initiated Jul 13, 2026

Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL

Reason: 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 of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.

Root cause: Unknown/Undetermined by firm

Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Enzyme Immunoassay, QuinidineDistribution: Worldwide - US Nationwide distribution in the state of CA and the country of Italy.Recall #Z-2976-2026

Open, ClassifiedPosted Aug 14, 2026·Initiated Jul 30, 2026

BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit for Powered Driver 35mm x 15Ga, REF: D015351NK, BD Needle Kit for Powered Driver 45mm x 15Ga, REF: D015451NK, BD Needle Kit for Powered Driver 55mm x 15Ga, REF: D015551NK

Reason: After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience difficulty/inability to remove obturator, due to it locking to the needle hub, due to out-of-tolerance dimensions and IFU unclarity, which may result in new needle placement, which may result in delayed therapy

Root cause: Component change control

Recalling firm: Bard Access Systems, Inc.Type: Needle, Hypodermic, Single LumenDistribution: US: MA, FL, IA, SC, IL, NY, UT, NJ, ID, IN, PA, CA, TX, OH, MO, VA, MD, NC, AL, MN, CO, KY, LA, NV, OK, MS, AZ, MI, GA, AR, KS, TN. OUS: CA, SGRecall #Z-2872-2026

Open, ClassifiedPosted Aug 14, 2026·Initiated Jul 24, 2026

Lago X

Reason: Momentary absence of On-Screen "X-Ray On" banner during run readiness check.

Root cause: Radiation Control for Health and Safety Act

Recalling firm: Spectral Instruments IncType: Cabinet X-Ray, IndustrialDistribution: United States.Recall #Z-2939-2026

Open, ClassifiedPosted Aug 14, 2026·Initiated Jul 24, 2026

Ami HTX

Reason: Momentary absence of On-Screen "X-Ray On" banner during run readiness check.

Root cause: Radiation Control for Health and Safety Act

Recalling firm: Spectral Instruments IncType: Cabinet X-Ray, IndustrialDistribution: United States.Recall #Z-2940-2026

Open, ClassifiedPosted Aug 14, 2026·Initiated May 13, 2026

EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684

Reason: Due to products are incorrectly flagged as expired due to the system's 24-hour usage limit, rendering the product unavailable for clinical procedures.

Root cause: Under Investigation by firm

Recalling firm: Covidien, LLCType: System, Gastrointestinal Motility (Electrical)Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Costa Rica, Denmark, France, Germany, Hong Kong, Ireland, Israel, Italy, Netherlands, New Zealand, Northern Ireland, Norway, Portugal, South Korea, Spain, Sweden, Switzerland, United Kingdom.Recall #Z-2950-2026

Open, ClassifiedPosted Aug 14, 2026·Initiated Jun 10, 2026

Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.

Reason: Software issue that can cause an increase in spontaneous software closures.

Root cause: Software design

Recalling firm: Foundation Medicine, Inc.Type: Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection SystemDistribution: US Nationwide distribution in the states of MA & NC.Recall #Z-2951-2026

Open, ClassifiedPosted Aug 14, 2026·Initiated Jun 15, 2026

One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.

Reason: Devices could potentially be occluded or partially occluded.

Root cause: Process control

Recalling firm: Intersurgical IncType: Airway, Oropharyngeal, AnesthesiologyDistribution: US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.Recall #Z-2952-2026

FDA Updates

Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter

American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF.

BMC/REACTHEALTH Luna G3 APAP REF LG 3600

Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 423725, 423726, 423727.

MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;

MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;

MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW

Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131

Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemistry Analyzers

Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analyzers

Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL

Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL

Lago X

Ami HTX

EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684

Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.

One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.