Open, ClassifiedPosted Jul 1, 2026·Initiated Apr 21, 2026
Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back Section H V U component (product code 1909813) on Baxter operating tables
Reason: The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating tables.
Root cause: Device Design
Recalling firm: Baxter Healthcare CorporationType: Table, Operating-Room, ElectricalDistribution: Worldwide - US Nationwide distribution in the states of Minnesota, Maryland, and Pennsylvania and the countries of Canada, Hong Kong, India, Japan, Korea, Philippines, Taiwan, Thailand, Vietnam, Austria, Belgium, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iraq, Israel, Italy, Jordan, Kenya, Lebanon, Libya, Malta, Morocco, Netherlands, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Slovakia, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arabia Emrites, Ukraine, Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico, and Peru.Recall #Z-2638-2026
Open, ClassifiedPosted Jul 1, 2026·Initiated May 7, 2026
Brand Name: Pilling Wecksorb
Product Name: Pilling Wecksorb Neurosponges (Cotton)
Pilling Wecksorb Neurosponge Strips (Cotton)
Model/Catalog Number:
200100
200101
200102
200103
200104
200105
200106
200108
200110
200112
200120
200121
200123
200131
Software Version: N/A
Product Description: Wecksorb Neurosponges are made of an absorbent cotton material. Certain Neurosponge varieties are available with an x-ray detectable thread to assist with location within the surgical site. Some Neurosponges (patties) have a string for accountability during the post-surgical verification process. Wecksorb Neurosponges are for use in the protection of tissue during surgical procedures; tissues include the brain and other central nervous system tissues.
Neuro sponges are used during cranial and spine surgery to moisten the dura or to cushion against bone edges. They are also used to protect brain tissue under the dura or elsewhere during incision.
Component: N/A
Reason: Due to out-of-specification, or potential out-of-specification, levels of endotoxins
Root cause: Device Design
Recalling firm: TELEFLEX LLCType: Gauze/Sponge, InternalDistribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Panama.Recall #Z-2639-2026
Open, ClassifiedPosted Jul 1, 2026·Initiated Jun 16, 2026
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Reason: In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
Root cause: Software design
Recalling firm: Accuray IncorporatedType: Accelerator, Linear, MedicalDistribution: Worldwide distribution - US Nationwide and the countries of China, Colombia, Czech Republic, France, Hong Kong, Japan, Korea, Republic of, Latvia, Mexico, Myanmar, Saudi Arabia, Taiwan, Turkey, Ukraine.Recall #Z-2640-2026 Open, ClassifiedPosted Jul 1, 2026·Initiated May 20, 2026
ARTIS icono biplane. Model Number: 11327600.
Reason: Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Root cause: Software design
Recalling firm: Siemens Medical Solutions USA, IncType: Interventional Fluoroscopic X-Ray SystemDistribution: US Nationwide distribution.Recall #Z-2641-2026
Open, ClassifiedPosted Jul 1, 2026·Initiated May 20, 2026
ARTIS icono ceiling. Model Number: 11328100.
Reason: Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Root cause: Software design
Recalling firm: Siemens Medical Solutions USA, IncType: Interventional Fluoroscopic X-Ray SystemDistribution: US Nationwide distribution.Recall #Z-2642-2026
Open, ClassifiedPosted Jul 1, 2026·Initiated May 20, 2026
ARTIS icono floor. Model Number: 11327700.
Reason: Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Root cause: Software design
Recalling firm: Siemens Medical Solutions USA, IncType: Interventional Fluoroscopic X-Ray SystemDistribution: US Nationwide distribution.Recall #Z-2643-2026
Open, ClassifiedPosted Jul 1, 2026·Initiated Jun 16, 2026
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Reason: In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
Root cause: Software design
Recalling firm: Accuray IncorporatedType: Accelerator, Linear, MedicalDistribution: Worldwide - US Nationwide and and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kenya, Korea, Republic of, Liechtenstein, Lithuania, Luxembourg, Macao, Mexico, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.Recall #Z-2644-2026 Open, ClassifiedPosted Jul 1, 2026·Initiated Jun 5, 2026
Brand Name: Medela
Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN
Model/Catalog Number: ENF060182LD / 101033086
Software Version: N/A
Product Description: Enteral Extension Set, Length 60 Orange-Striped Minibore Tubing,
(Approx. Priming Vol. 2.00 mL), ENFit
Component: N/A
Reason: May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.
Root cause: Process change control
Recalling firm: Medela IncType: Set, Administration, IntravascularDistribution: US distribution to the following states: AZ, CA, CO, FL, HI, IL, IN, MD, MI, MN, MO, NC, NJ, NY,
OR, PA, TX, VA.Recall #Z-2645-2026
Open, ClassifiedPosted Jul 1, 2026·Initiated May 20, 2026
RayCare 2024A SP1. Oncology Information Systems.
Reason: Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
Root cause: Under Investigation by firm
Recalling firm: RAYSEARCH LABORATORIES ABType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide - US Nationwide distribution.Recall #Z-2646-2026
Open, ClassifiedPosted Jul 1, 2026·Initiated May 20, 2026
RayCare 2024A SP4. Oncology Information Systems.
Reason: Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
Root cause: Under Investigation by firm
Recalling firm: RAYSEARCH LABORATORIES ABType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide - US Nationwide distribution.Recall #Z-2647-2026
Open, ClassifiedPosted Jul 1, 2026·Initiated Jun 8, 2026
ARTIS icono ceiling. Model Number: 11328100.
Reason: Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.
Root cause: Device Design
Recalling firm: Siemens Medical Solutions USA, IncType: Interventional Fluoroscopic X-Ray SystemDistribution: US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.Recall #Z-2648-2026
Open, ClassifiedPosted Jul 1, 2026·Initiated Jun 1, 2026
Zeiss Intrabeam Spherical Applicator 1.5 cm
REF:304534-6000-557
Reason: Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Root cause: Employee error
Recalling firm: Carl Zeiss Meditec AGType: System, Therapeutic, X-RayDistribution: Worldwide - US Nationwide distribution in the state and territories of Florida and Puerto Rico. The countries of China, Germany, Ecuador, Spain, France, Malaysia, Philippines, Poland, and Romania.Recall #Z-2649-2026 Open, ClassifiedPosted Jun 30, 2026·Initiated May 29, 2026
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
Reason: Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal to overcome membrane adhesion or replacement
Root cause: Component design/selection
Recalling firm: Hamilton Medical AGType: Set, Tubing And Support, Ventilator (W Harness)Distribution: US Nationwide distribution including in the states of KS, WA, VT, TX, WI, AR, OH, PA, CA, CO, ID, AZ, ME, MO, MI, IL, OR, VA, FL, NJ, SD, NY, NM, TN, CT, NE, OK, AL, GA, KY, NH, WY, ND, IN, UT, WV, DE, IA, PR, MN, LA, AK, HI.Recall #Z-2463-2026
Open, ClassifiedPosted Jun 30, 2026·Initiated May 20, 2026
Omnipod 5 Pods. Includes the below Model/REF Numbers:
1. POD-OMNI-I1-6720.
2. POD-OMNI-I1-6220.
3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod).
4. OMNI-I1-6220.
5. OMNI-I1-6720.
6. BLE-H1-529 (10-Pack), BLE-H1-520 (Single Pod).
Reason: External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death.
Root cause: Process design
Recalling firm: Insulet CorporationType: Alternate Controller Enabled Insulin Infusion PumpDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Finland, France, UK, Greece, Israel, Italy, Kuwait, Leichtenstein, Netherlands, Norway, Saudi Arabia, Sweden and Turkey.Recall #Z-2603-2026
Open, ClassifiedPosted Jun 30, 2026·Initiated May 20, 2026
Omnipod DASH Pod. Includes the below Model/REF Numbers:
1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod).
2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod).
3. BLE-I1-529 (10-Pack), BLE-I1-520 (Single Pod).
4. BLE-C1-529 (10-Pack), BLE-C1-520 (Single Pod).
Reason: External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death.
Root cause: Process design
Recalling firm: Insulet CorporationType: Pump, Infusion, InsulinDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Finland, France, UK, Greece, Israel, Italy, Kuwait, Leichtenstein, Netherlands, Norway, Saudi Arabia, Sweden and Turkey.Recall #Z-2604-2026
Open, ClassifiedPosted Jun 30, 2026·Initiated May 20, 2026
Omnipod (Eros) Pod. Includes the below Model/REF Numbers:
1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod).
2. ZXR425 (10-Pack), ZXR420 (Single Pod).
3. ZXP425 (10 Pack), ZXP420 (Single Pod).
Reason: External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death.
Root cause: Process design
Recalling firm: Insulet CorporationType: Pump, Infusion, InsulinDistribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Finland, France, UK, Greece, Israel, Italy, Kuwait, Leichtenstein, Netherlands, Norway, Saudi Arabia, Sweden and Turkey.Recall #Z-2605-2026
Open, ClassifiedPosted Jun 30, 2026·Initiated Jun 3, 2026
GC Agar Base (150mm) 10/PK R04030;
GC Agar Base (100mm) 10/PK R01460
Reason: Reduced or no recovery of some strains of Neisseria gonorrhoeae.
Root cause: Under Investigation by firm
Recalling firm: Remel, IncType: Culture Media, For Isolation Of Pathogenic NeisseriaDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom.Recall #Z-2623-2026
Open, ClassifiedPosted Jun 29, 2026·Initiated May 21, 2026
Medline Convenience Kits:
1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145;
2) Universal Central/Art Line Insertion Kit, Model Number: ART155A;
3) ARTERIAL LINE INSERTION TRAY, Model Number: ART1010B
Reason: The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Arterial Blood Sampling KitDistribution: US Nationwide distribution.Recall #Z-2533-2026
Open, ClassifiedPosted Jun 29, 2026·Initiated May 21, 2026
Medline Convenience Kits:
1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L;
2) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1317;
3) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1579A;
4) CSE TRAY, Model Number: PAIN1885A;
5) REINFORCED CATH EPIDURAL TRAY, Model Number: PAIN1967A;
6) TRAY,CON EPID,19G REINF OPNTIP, Model Number: PAIN2269;
7) EPIDURAL TRAY, Model Number: PAIN2278;
8) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN2305;
9) CSE TRAY MEDLINE, Model Number: PAIN2334;
10) PNBT TRAY, Model Number: SAMPA0147
Reason: The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Spinal Epidural Anesthesia KitDistribution: US Nationwide distribution.Recall #Z-2534-2026
Open, ClassifiedPosted Jun 29, 2026·Initiated May 21, 2026
Medline Convenience Kits:
1) BLOCK TRAY, Model Number: DYNJRA1590
Reason: The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Nerve Block TrayDistribution: US Nationwide distribution.Recall #Z-2535-2026