Open, ClassifiedPosted Jun 25, 2026·Initiated Feb 27, 2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.
FTMC C-SECTION TRAY-LF
DYNJ54603B
Reason: Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA.
Products not initially reported in RES 98601.
Root cause: No Marketing Application
Recalling firm: Medline Industries, LPType: Cesarean Section TrayDistribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS,
KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI,
WY and the country of Barbados.Recall #Z-2596-2026
Open, ClassifiedPosted Jun 25, 2026·Initiated May 22, 2026
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
Reason: Potential for thrombus formation during prolonged use of the introducer.
Root cause: Under Investigation by firm
Recalling firm: Abiomed, Inc.Type: Introducer, CatheterDistribution: Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.Recall #Z-2599-2026 Open, ClassifiedPosted Jun 25, 2026·Initiated May 22, 2026
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
Reason: Potential for thrombus formation during prolonged use of the introducer.
Root cause: Under Investigation by firm
Recalling firm: Abiomed, Inc.Type: Introducer, CatheterDistribution: Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.Recall #Z-2600-2026 Open, ClassifiedPosted Jun 25, 2026·Initiated May 22, 2026
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
Reason: Potential for thrombus formation during prolonged use of the introducer.
Root cause: Under Investigation by firm
Recalling firm: Abiomed, Inc.Type: Introducer, CatheterDistribution: Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.Recall #Z-2601-2026 Open, ClassifiedPosted Jun 25, 2026·Initiated May 22, 2026
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Reason: Potential for thrombus formation during prolonged use of the introducer.
Root cause: Under Investigation by firm
Recalling firm: Abiomed, Inc.Type: Introducer, CatheterDistribution: Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.Recall #Z-2602-2026 Open, ClassifiedPosted Jun 24, 2026·Initiated May 6, 2026
Medline Convenience Kits:
1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP;
2) DYNJ905503G, Model Number: CV ANESTHESIA - ROOM SET UP
Reason: The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Circuit, Breathing (W Connector, Adaptor, Y Piece)Distribution: US Nationwide.Recall #Z-2452-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated May 6, 2026
Medline Convenience Kits:
1) OPEN HEART CDS, Model Number: CDS840144Q;
2) OPEN HEART, Model Number: CDS840150W;
3) OPEN HEART ADULT, Model Number: CDS840396AA;
4) CABG A CDS, Model Number: CDS982269N;
5) OPEN HEART ANESTHESIA PACK, Model Number: CDS983849G;
6) OPEN HEART ACCESSORY CDS, Model Number: CDS984289L;
7) OPEN HEART A, Model Number: CDS985105Q;
8) OPEN HEART PART 2, Model Number: DYNJ901075R;
9) VPH OPEN HEART, Model Number: DYNJ902664L;
10) HEART A, Model Number: DYNJ903465I;
11) HEART, Model Number: DYNJ903822F;
12) OPEN HEART BASIC B, Model Number: DYNJ904311F;
13) SM OPEN HEART PACK A&B, Model Number: DYNJ904749J;
14) OPEN HEART ANESTHESIA ICC-B, Model Number: DYNJ905567B;
15) SILVER CROSS OPEN HEART, Model Number: DYNJ906102K;
16) ANESTHESIA OPEN HEART, Model Number: DYNJ906225I;
17) OPEN HEART COMBO, Model Number: DYNJ907400F;
18) CARDIAC CABG B, Model Number: DYNJ908121C;
19) FS OPEN HEART, Model Number: DYNJ908308A;
20) OPEN HEART SUPPLEMENT, Model Number: DYNJ909116D;
21) MEM CARDIAC, Model Number: DYNJ9622573AP;
22) OPEN HEART A & B PACK, Model Number: DYNJ9718008AT
Reason: The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Cardiovascular Procedure KitDistribution: US Nationwide.Recall #Z-2453-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated May 6, 2026
Medline Convenience Kits:
1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ACC011142;
2) CENTRAL AND ARTERIAL LINE TOTE, Model Number: DYNJ8407
Reason: The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Central Venous Catheter TrayDistribution: US Nationwide.Recall #Z-2454-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated May 6, 2026
Medline Convenience Kits:
1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890;
2) OPEN HEART A OVERHEAD, Model Number: DYNJ910066;
3) OPEN HEART, Model Number: DYNJ9855016V;
4) OPEN HEART, Model Number: DYNJ9855016X
Reason: The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: General Surgery TrayDistribution: US Nationwide.Recall #Z-2455-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated Apr 6, 2026
INZONE DETACHMENT SYSTEM, REF: M00345100950
Reason: Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.
Root cause: Component design/selection
Recalling firm: Stryker NeurovascularType: Device, Neurovascular EmbolizationDistribution: Worldwide - US Nationwide distribution including in the states of PA, AZ, FL, CA, IL, AK, NY, MI, NJ, WI, SD, KY, AR, TX, AL, TN, MO, MA, IN, NE, WV, MT, CT, NC, VA, NV, CO, DC, DE, OH, ME, GA, WA, SC, GU, MN, OK, NH, MD, ND, UT, HI, OR, LA, MS, KS, NM, ID, IA, VT and the countries of ARGENTINA, AUSTRIA, BELGIUM, BRASIL, BULGARIA, CANADA, CANARY ISLANDS, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, IRAN, IRELAND, ISRAEL, ITALIA, JAPAN, KOREA, LATVIA, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NORTHERN IRELAND, NORWAY, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH PACIFIC, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM.Recall #Z-2552-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated May 8, 2026
GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
Reason: GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one. When this issue occurs, there is no system warning or error notification. If the error is not recognized, a clinical user could review, interpret, or report images for the wrong patient which could lead to misdiagnosis, incorrect clinical decisions, resulting in delayed or incorrect treatment.
Root cause: Software design
Recalling firm: GE Medical Systems SCSType: System, Image Processing, RadiologicalDistribution: Worldwide distribution - United States Nationwide and the countries of Algeria, Australia, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Korea (Republic Of), Lithuania, Morocco, Nepal, Netherlands, New Zealand, North Macedonia, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkiye, United Arab Emirates, United Kingdom, Vietnam.Recall #Z-2553-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated May 5, 2026
Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Reason: Software anomaly that causes a false display of error code 5018.
Root cause: Device Design
Recalling firm: IPG Medical CorporationType: Powered Laser Surgical InstrumentDistribution: US Nationwide distribution in the state of MA.Recall #Z-2554-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated Apr 30, 2026
Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered)
Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Root cause: Under Investigation by firm
Recalling firm: SURGIFY MEDICAL OYType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.Recall #Z-2555-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated Apr 30, 2026
Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Root cause: Under Investigation by firm
Recalling firm: SURGIFY MEDICAL OYType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.Recall #Z-2556-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated Apr 30, 2026
Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Root cause: Under Investigation by firm
Recalling firm: SURGIFY MEDICAL OYType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.Recall #Z-2557-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated Apr 30, 2026
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Root cause: Under Investigation by firm
Recalling firm: SURGIFY MEDICAL OYType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.Recall #Z-2558-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated Apr 30, 2026
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Root cause: Under Investigation by firm
Recalling firm: SURGIFY MEDICAL OYType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.Recall #Z-2559-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated Apr 30, 2026
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Root cause: Under Investigation by firm
Recalling firm: SURGIFY MEDICAL OYType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.Recall #Z-2560-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated Apr 30, 2026
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Root cause: Under Investigation by firm
Recalling firm: SURGIFY MEDICAL OYType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.Recall #Z-2561-2026
Open, ClassifiedPosted Jun 24, 2026·Initiated Apr 30, 2026
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Reason: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Root cause: Under Investigation by firm
Recalling firm: SURGIFY MEDICAL OYType: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.Recall #Z-2562-2026