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Medical Devices Recalls

39,793 recalls, newest first.

July 15, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D; 2) ACCESSORY KIT, Model Number: DYNJ9013
Hazard: Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.
July 15, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A
Hazard: Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.
July 15, 2026Medical DevicesFDA
Boston Scientific Neuromodulation Corporation recalls Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMEN
Hazard: Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.
July 15, 2026Medical DevicesFDA
ConvaTec, Inc recalls Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Hazard: Surgical dressing manufactured out of specification (greater thickness).
July 15, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designe
Hazard: Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
July 8, 2026Medical DevicesFDA
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors M
Hazard: Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.
July 8, 2026Medical DevicesFDA
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Mod
Hazard: Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.
July 8, 2026Medical DevicesFDA
W L Gore & Associates, Inc. recalls GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Pu
Hazard: Due to catheter separation
July 8, 2026Medical DevicesFDA
Masimo Corporation recalls Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
Hazard: Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
July 8, 2026Medical DevicesFDA
Masimo Corporation recalls Radius VSM ECG pre-connected Set, REF: 4842, 4695
Hazard: Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
July 8, 2026Medical DevicesFDA
Laborie Medical Technologies Corp recalls Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar
Hazard: Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter and waterproof pressure sensors. Accumulated moisture may affect airflow or pressure measurement performance if not properly removed.
July 8, 2026Medical DevicesFDA
Bard Access Systems, Inc. recalls 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 01108
Hazard: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
July 8, 2026Medical DevicesFDA
Bard Access Systems, Inc. recalls CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 S4153108BDP Provena Midline Catheter 3
Hazard: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
July 8, 2026Medical DevicesFDA
Bard Access Systems, Inc. recalls 1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC SOLO Catheter 5 Fr Dual-L
Hazard: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
July 8, 2026Medical DevicesFDA
Bard Access Systems, Inc. recalls 7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Groshong¿ NXT PICC provid
Hazard: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
July 8, 2026Medical DevicesFDA
Bard Access Systems, Inc. recalls CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 CK000883 PowerPICC Provena Cat
Hazard: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
July 8, 2026Medical DevicesFDA
Bard Access Systems, Inc. recalls CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidline Catheter 4 Fr Dual
Hazard: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
July 8, 2026Medical DevicesFDA
Bard Access Systems, Inc. recalls CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729 PowerMidline Catheter 4 Fr Sin
Hazard: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
July 8, 2026Medical DevicesFDA
Bard Access Systems, Inc. recalls 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177
Hazard: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
July 8, 2026Medical DevicesFDA
Bard Access Systems, Inc. recalls 5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 5605240
Hazard: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
July 8, 2026Medical DevicesFDA
Bard Access Systems, Inc. recalls 1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen
Hazard: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
July 8, 2026Medical DevicesFDA
Bard Access Systems, Inc. recalls CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide intern
Hazard: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
July 8, 2026Medical DevicesFDA
Bard Access Systems, Inc. recalls 5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 The intended u
Hazard: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
July 8, 2026Medical DevicesFDA
Bard Access Systems, Inc. recalls CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Si
Hazard: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
July 8, 2026Medical DevicesFDA
Bard Access Systems, Inc. recalls OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI
Hazard: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
July 8, 2026Medical DevicesFDA
BD SWITZERLAND SARL recalls MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering S
Hazard: Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
July 8, 2026Medical DevicesFDA
Covidien LLC recalls Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the
Hazard: Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
July 8, 2026Medical DevicesFDA
Carl Zeiss Meditec AG recalls Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Hazard: Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
July 8, 2026Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls ARTIS icono ceiling. Model Number: 11328100.
Hazard: 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.
July 8, 2026Medical DevicesFDA
RAYSEARCH LABORATORIES AB recalls RayCare 2024A SP4. Oncology Information Systems.
Hazard: 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.