Open, ClassifiedPosted May 1, 2026·Initiated Mar 13, 2026
Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.
Reason: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: Cardiac Catheterization KitDistribution: US distribution to FL, IL, MO, MS, NC, NE, TX.Recall #Z-1978-2026
Open, ClassifiedPosted May 1, 2026·Initiated Mar 13, 2026
Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.
Reason: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: Cardiac Catheterization KitDistribution: US distribution to FL, IL, MO, MS, NC, NE, TX.Recall #Z-1979-2026
Open, ClassifiedPosted May 1, 2026·Initiated Apr 2, 2026
Brand Name: Da Vinci X and Da Vinci Xi
Product Name: da Vinci X, Xi Surgical System
Model/Catalog Number: IS4000; IS4200
Software Version: N/A
Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery.
Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument
Reason: Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
Root cause: Nonconforming Material/Component
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Malta, Mexico, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.Recall #Z-2046-2026
Open, ClassifiedPosted May 1, 2026·Initiated Mar 30, 2026
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
Reason: For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)Distribution: Worldwide distribution - US Nationwide and the country of Belgium.Recall #Z-2048-2026 Open, ClassifiedPosted May 1, 2026·Initiated Mar 30, 2026
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
Reason: For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)Distribution: Worldwide distribution - US Nationwide and the country of Belgium.Recall #Z-2049-2026 Open, ClassifiedPosted May 1, 2026·Initiated Mar 20, 2026
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5
Total cervical disc replacement.
Reason: Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
Root cause: Labeling mix-ups
Recalling firm: Centinel Spine, Inc.Type: Prosthesis, Intervertebral DiscDistribution: US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.Recall #Z-2050-2026
Open, ClassifiedPosted May 1, 2026·Initiated Mar 20, 2026
Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6.
Total cervical disc replacement.
Reason: Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
Root cause: Labeling mix-ups
Recalling firm: Centinel Spine, Inc.Type: Prosthesis, Intervertebral DiscDistribution: US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.Recall #Z-2051-2026
Open, ClassifiedPosted May 1, 2026·Initiated Mar 26, 2026
Brand Name: Spacelabs Ultraview SL Command Module
Product Name: SL Command Module
Model/Catalog Number: 91496
Software Version: N/A
Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic parameters. The Command Module inserts into the side of a Spacelabs patient monitor. A variety of configurations can be selected to suit the monitoring needs of specific patients or care units in the hospital.
Component: N/A
Reason: Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
Root cause: Process control
Recalling firm: Spacelabs Healthcare, Inc.Type: Detector And Alarm, ArrhythmiaDistribution: Worldwide - US Nationwide di GA, KS, MI, OH, SC, TX, WA and the country of ARGENTINA.Recall #Z-2052-2026
Open, ClassifiedPosted May 1, 2026·Initiated Mar 31, 2026
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 20325-207; ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Set for Fujifilm Scopes, REF: 20325-248; Hybrid CO2 Tubing/Cap Set for Fujinon Scopes, REF: 20325-208
Reason: Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
Root cause: Component change control
Recalling firm: Erbe Medical, LLCType: Pump, Air, Non-Manual, For EndoscopeDistribution: US Nationwide distribution including in the states of IL, NY, CA, WA, UT, KY, PA, TX, AL, OH, FL, IN, NJ, NH, MI, CT, AR, MN, WI, AZ, CO, WV, MT, HI, TN, GA, VA, OK, RI, MO, NM, ID, SC, WY, KS, NC, MS, OR, MD, MA, DE, NE, AK, IA, DC, ME, LA, SD, ND, VT, PR, NV.Recall #Z-2062-2026
Open, ClassifiedPosted May 1, 2026·Initiated Mar 31, 2026
ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;
Reason: Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
Root cause: Component change control
Recalling firm: Erbe Medical, LLCType: Endoscopic Irrigation/Suction SystemDistribution: US Nationwide distribution including in the states of IL, NY, CA, WA, UT, KY, PA, TX, AL, OH, FL, IN, NJ, NH, MI, CT, AR, MN, WI, AZ, CO, WV, MT, HI, TN, GA, VA, OK, RI, MO, NM, ID, SC, WY, KS, NC, MS, OR, MD, MA, DE, NE, AK, IA, DC, ME, LA, SD, ND, VT, PR, NV.Recall #Z-2063-2026
Open, ClassifiedPosted May 1, 2026·Initiated Mar 31, 2026
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
Reason: Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
Root cause: Component change control
Recalling firm: Erbe Medical, LLCType: Endoscopic Irrigation/Suction SystemDistribution: US Nationwide distribution including in the states of IL, NY, CA, WA, UT, KY, PA, TX, AL, OH, FL, IN, NJ, NH, MI, CT, AR, MN, WI, AZ, CO, WV, MT, HI, TN, GA, VA, OK, RI, MO, NM, ID, SC, WY, KS, NC, MS, OR, MD, MA, DE, NE, AK, IA, DC, ME, LA, SD, ND, VT, PR, NV.Recall #Z-2064-2026
Open, ClassifiedPosted Apr 30, 2026·Initiated Mar 19, 2026
Medline Neuro Sponges, various dimensions, labeled as:
1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" X 0.25", XR, 10/PK, Medline SKU NEUROSPNG02;
2. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 0.5", XR, 10/PK, Medline SKU NEUROSPNG05;
3. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 1", XR, LF, 10/PK, Medline SKU NEUROSPNG06;
4. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 1.5", XR, LF, 10/PK, Medline SKU NEUROSPNG07;
5. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 3", XR, LF, 10/PK, Medline SKU NEUROSPNG09;
6. Neuro Sponges, Eponges neuro, Neuroesponjas, size .75" X .75", XR, LF, 10/PK, Medline SKU NEUROSPNG11;
7. Neuro Sponges, Eponges neuro, Neuroesponjas, size 1" X 1", XR, LF, 10/PK, Medline SKU NEUROSPNG13;
8. Neuro Sponges, Eponges neuro, Neuroesponjas, size 1" X 3", XR, LF, 10/PK, Medline SKU NEUROSPNG14.
Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Neurosurgical PaddieDistribution: Worldwide distribution.Recall #Z-2008-2026
Open, ClassifiedPosted Apr 30, 2026·Initiated Mar 19, 2026
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: PEDS AIRWAY PACK, Medline Kit Number SKU DYNJ86657A
Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Circuit, Breathing (W Connector, Adaptor, Y Piece)Distribution: Worldwide distribution.Recall #Z-2009-2026
Open, ClassifiedPosted Apr 30, 2026·Initiated Mar 19, 2026
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: EH BRONCHOSCOPY, Medline Kit Number/SKU DYNJT3270
Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Tracheobronchial Suction Catheter KitDistribution: Worldwide distribution.Recall #Z-2010-2026
Open, ClassifiedPosted Apr 30, 2026·Initiated Mar 19, 2026
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline Kit Number/SKU CDS860017AG
Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Spinal Epidural Anesthesia KitDistribution: Worldwide distribution.Recall #Z-2011-2026
Open, ClassifiedPosted Apr 30, 2026·Initiated Mar 19, 2026
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B
Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Epidural Anesthesia KitDistribution: Worldwide distribution.Recall #Z-2012-2026
Open, ClassifiedPosted Apr 30, 2026·Initiated Mar 19, 2026
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:
1. NEURO PACK, Medline kit number/SKU DYNJ64479;
2. CRANIO/NEURO/SPINE, Medline kit number/SKU DYNJ901072D.
Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Nerve Block TrayDistribution: Worldwide distribution.Recall #Z-2013-2026
Open, ClassifiedPosted Apr 30, 2026·Initiated Mar 19, 2026
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF, Medline Kit Number/SKU DYNJ0774765U
Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Angiography/Angioplasty KitDistribution: Worldwide distribution.Recall #Z-2014-2026
Open, ClassifiedPosted Apr 30, 2026·Initiated Mar 19, 2026
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:
1. MAJOR NEURO PACK-LF, Medline Kit Number/SKU DYNJ0578916X;
2. ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ51637D;
3. NEURO SEO, Medline Kit Number/SKU DYNJ65650.
Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Cardiac Catheterization KitDistribution: Worldwide distribution.Recall #Z-2015-2026
Open, ClassifiedPosted Apr 30, 2026·Initiated Mar 19, 2026
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:
1. OPEN HEART CDS PART A, Medline Kit Number/SKU CDS840402AI;
2. OPEN HEART CDS, Medline Kit Number/SKU CDS984890V;
3. RR-NEURO VASCULAR PACK-LF, Medline Kit Number/SKU DYNJ0394874L;
4. VP SHUNT PACK-LF, Medline Kit Number/SKU DYNJ0750993M;
5. PEDI VP SHUNT ADD A PACK-LF, Medline Kit Number/SKU DYNJ0753933G;
6. FESS-MB PACK-LF, Medline Kit Number/SKU DYNJ0888159I;
7. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861C;
8. POSTERIOR LUMBAR PACK, Medline Kit Number/SKU DYNJ42626B;
9. CV CUTDOWN PACK, Medline Kit Number/SKU DYNJ45374F;
10. X RAY CLOSED PACK, Medline Kit Number/SKU DYNJ48949C;
11. RFD- AAA PACK, Medline Kit Number/SKU DYNJ54242B;
12. NEURO LAM, Medline Kit Number/SKU DYNJ64188A;
13. LIVE OAK SINUS ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ69223;
14. FEM POP PACK, Medline Kit Number/SKU DYNJ81423C;
15. ENS FREEFLAP PROCDURE - LF, Medline Kit Number/SKU DYNJ88249;
16. OPEN HEART A&B, Medline Kit Number/SKU DYNJ901203D;
17. NEURO ACD, Medline Kit Number/SKU DYNJ904549F;
18. KIT VP SHUNT RFD, Medline Kit Number/SKU DYNJ906303F;
19. ACDF-LF, Medline Kit Number/SKU DYNJ906681C;
20. ACDF-LF, Medline Kit Number/SKU DYNJ906681D;
21. ACDF-LF, Medline Kit Number/SKU DYNJ906681F;
22. UNIVERSITY FREE FLAP, Medline Kit Number/SKU DYNJ907196B;
23. UNIVERSITY FREE FLAP, Medline Kit Number/SKU DYNJ907196C;
24. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ908362F;
25. VP SHUNT, Medline Kit Number/SKU DYNJ909379;
26. VP SHUNT, Medline Kit Number/SKU DYNJ909379A.
Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Cardiovascular Procedure KitDistribution: Worldwide distribution.Recall #Z-2016-2026