FDA (Device enforcement)

11,102 recalls · page 5 of 112

• Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530B2026-05-28
• Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G HEART A DYNJ903465K OPEN HEART DYNJ909090G SILVER CROSS OPEN HEART DYNJ906102M VPH OPEN HEART DYNJ902664M DYNJ902664N2026-05-28
• Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL LINE TOTE DYNJ84072026-05-28
• Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B2026-05-28
• Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET UP DYNJ905503D DYNJ905503F DYNJ905503G2026-05-28
• Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M2026-05-28
• Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A2026-05-28
• Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS982269L CDS982269M CDS982269N CARDIAC MAJOR DYNJ901328D DYNJ901328F HEART A DYNJ903465F DYNJ903465G HEART TRAY-VASCULAR DYNJ907857 DYNJ907857A DYNJ907857B KIT UNIVERSITY CABG PK DYNJ905857A OPEN HEART CDS9811612026-05-28
• Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A2026-05-28
• Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D; 2) ACCESSORY KIT, Model Number: DYNJ901348F2026-05-28
• Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART PEDS PACK, Model Number: DYNJ88569A; 3) OPEN HEART PEDS PACK, Model Number: DYNJ88569B; 4) OPEN HEART PEDS PACK, Model Number: DYNJ88569C2026-05-28
• SeaSpine Polyaxial Head REF Number: 41-30102026-05-28
• Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-282026-05-27
• Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number: STP-AT-012 Software Version: N/A Product Description: Dexcom G7 US Retail Sensor/Transmitter 1-pack Component: Dexcom G7 Continuous Glucose Monitoring System2026-05-27
• MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-18962026-05-27
• Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A2026-05-26
• Philips Avalon Fetal Monitor, FM 30 Part numberM2703A2026-05-26
• Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.2026-05-22
• Medtronic Harmony Delivery Catheter System2026-05-22
• IntelliCuff, Portable automatic cuff pressure controller REF: 9510012026-05-22
• GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.2026-05-22
• GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.2026-05-22
• MOSAIQ Oncology Information System2026-05-21
• BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic monitoring. When used with IV lipid2026-05-21
• 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: ART1010B2026-05-21
• 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 EP2026-05-21
• Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA15902026-05-21
• Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 2) TRIPLE LUMEN CENTRAL LINE BUNDLE, Model Number: ECVC2625; 3) INTROFLEX 6F, 1L, TB, US, Model Number: STCVC26US; 4) AVA HIGH FLOW, Model Number: ECVC3720; 5) CDP, MM, 3L, 7F, 16CM, H, Model Number: 3K16H1838;2026-05-21
• Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2) PAIN1470A, Model Number: CONT. 20G EPI MRI COMPATIBLE; 3) TVS4000L, Model Number: TVS4000 ENDOVENOUS PACK2026-05-21
• Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; 2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number: I505BF9C2026-05-21
• Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST BIOPSY PACK, Model Number: PHS234706I2026-05-21
• Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT137102026-05-21
• Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO CATH CENTRAL LINE KIT, Model Number: CVI4880B; 3) 20G x 6" ARTERIAL CATHETER KIT, Model Number: ART356; 4) MULTIMED 7FR, 16CM, 3L CVC BUNDLE, Model Number: STCVC03; 5) A-LINE KIT, NO CATH, Model Number: ARTNC217; 6)2026-05-21
• Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 3) CONTRACEPTIVE IMPLANT INSERTION KIT, Model Number: MNS9715; 4) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 5) MYELOGRAM PACK, Model Number: P155615A; 6) CHEST TUBE INSERTIO2026-05-21
• Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS33502026-05-21
• Medline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH12152026-05-21
• Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699A2026-05-21
• Medline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT6780; 2) CIRCUMCISION TRAY W/1.1CM CIRCLAMP, Model Number: CIT3225A; 3) CIRCUMCISION TRAY, Model Number: CIT63252026-05-21
• Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A2026-05-21
• Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device2026-05-21
• Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device2026-05-21
• Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device2026-05-21
• Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device2026-05-21
• CRE Pro Wireguided 6-8mm 240cm2026-05-21
• CRE Pro Wireguided 8-10mm 240cm2026-05-21
• CRE Pro Wireguided 10-12mm 240cm2026-05-21
• CRE Pro Wireguided 12-15mm 240cm2026-05-21
• CRE Pro Wireguided 15-18mm 240cm2026-05-21
• CRE Pro Wireguided 18-20mm 240cm2026-05-21
• CRE Wireguided 6-8mm 240cm2026-05-21
• CRE Wireguided 8-10mm 240cm2026-05-21
• CRE Wireguided 10-12mm 240cm2026-05-21
• CRE Wireguided 12-15mm 240cm2026-05-21
• CRE Wireguided 15-18mm 240cm2026-05-21
• CRE Wireguided 18-20mm 240cm2026-05-21
• CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 The Poly Per-Q-Cath Midline catheters are indicated for short or lon2026-05-21
• 5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 The intended use of the Short-Term Dialysis Catheter is attaining temporary/short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, or apheresis therapy via the jugular, subcla2026-05-21
• CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internal reinforcement to aid in catheter placement.2026-05-21
• 1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen REKV2227 00801741027536 The PowerPlCC SV catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.2026-05-21
• 5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 5605240 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086977 5605300 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen U2026-05-21
• 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 5855300 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107184 5865120 Power-Trialysis Slim-Cath Precurved Extension Short-Te2026-05-21
• CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138713 P4153108D PowerMidline Catheter 3 Fr Single-lumen UDI-DI Code: 00801741108747 P4154108 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 0080172026-05-21
• CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129278 P4254108D PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129353 The PowerMidline" Catheter is intended for short term peripheral access f2026-05-21
• CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 CK000883 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188800 CK000884A PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741219177 CK001000 PowerPICC Provena SOLO Catheter 4 Fr Du2026-05-21
• 7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Groshong¿ NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.2026-05-21
• 1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC SOLO Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034602 1174108D3 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1174108D4 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155048 12026-05-21
• CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154003 S4153108BP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153990 S4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-2026-05-21
• Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley system (G3-8), Solar GI HRM H2O, 36p, Trolley system (G3-12), Solar GI HRAM H2O, 24p, Trolley system (G3-12026-05-21
• Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.2026-05-21
• GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at t2026-05-21
• GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A2026-05-21
• Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 1100402402026-05-20
• Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 1100402412026-05-20
• Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 1100402422026-05-20
• 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).2026-05-20
• 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).2026-05-20
• 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).2026-05-20
• ARTIS icono biplane. Model Number: 11327600.2026-05-20
• ARTIS icono ceiling. Model Number: 11328100.2026-05-20
• ARTIS icono floor. Model Number: 11327700.2026-05-20
• Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A2026-05-20
• Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A2026-05-20
• Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No2026-05-20
• Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthop2026-05-20
• Medtronic O-arm O2 Imaging System. Model Number: BI70002000.2026-05-19
• TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.2026-05-19
• TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.2026-05-19
• Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN B; Part Number: 151730010. 2. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN C; Part Number: 152026-05-19
• Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 10mm B; Part Number: 151730410. 2. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 12mm B; Part Number: 151730412. 3. ATTUNE KNEE SYSTEM REVI2026-05-19
• GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A EMEA Countries, Australia, New Zealand: TSB080806E, TSB081006E, 2026-05-19
• Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.2026-05-19
• 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 - 205942,2026-05-19
• 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.2026-05-19
• Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT, Model/Item Number (kit) ACEN89-02; 3) BACK PACK, Model/Item Number (kit) ALBK51-01; 4) DR DERIAN SPINE PACK SNEDHCPDH, Model/Item Number (kit) DGSP71; 5) BASIC PACK DR BROWN SBADHBPR16, Model/Item Number 2026-05-19
• 1) NEURO, (kit) ACNE73-01; 2) NEURO, (kit) ACNE73-03; 3) CRANI, (kit) AKCR19-01; 4) ORTHO SPINE PACK, (kit) ARMC017; 5) BMHM NEURO PACK, (kit) BMHT016-05; 6) LUMBAR PACK, (kit) BMHT112-03; 7) NEURO LAMINECTOMY PACK, (kit) DGNE75; 8) NEURO LAMINECTOMY PACK, (kit) DGNE75-02; 9) DRAH NEURO LAMINECTOMY 2026-05-19
• Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01; 2) POSTERIOR PACK - 205960, Model/Item Number (kit) ANPP15-01; 3) ANEURYSM PACK, Model/Item Number (kit) BPAY14-01; 4) SPINE PACK, Model/Item Number (kit) HSLM53-01; 5) ANTERIOR CERVICAL PACK - 20592026-05-19
• Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.2026-05-18
• GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.2026-05-18
• ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.2026-05-18
• HarmonyAIR A-Series Surgical Lighting System2026-05-15