Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 76 - 100 of 1,678 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston A single lot of expired syringes were distributed due to a distribution system control failure.	FDA Z-2614-2026	Medical Device	High	Jul 8, 2026 Recall: Apr 28, 2026	Details
Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Number / UDI-DI code 4DCFN 10884522006576 4DCFS 10884522006583 4DFEN 10884522006606 6DCFN 10884522006613 6DCFS 10884522006620 6DFEN 10884522006644 8DCFN 10884522006651 8DCFS 40884522006690 8DFEN 10884522006675 10DCFN 20884522006535 10DCFS 10884522006545 10DFEN 10884522006569 The Shiley Disposable Decannulation Plug (DDCP) is a universal size and fits any size DCFS, DCFN, DFEN tracheostomy tube. The red DDCP snaplock connect Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.	FDA Z-2653-2026	Medical Device	High	Jul 8, 2026 Recall: Apr 23, 2026	Details
CRE Pro Wireguided 15-18mm 240cm Potential sterile breach of the pouches in which devices are packaged.	FDA Z-2630-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
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. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.	FDA Z-2659-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
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 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.	FDA Z-2645-2026	Medical Device	High	Jul 8, 2026 Recall: Jun 5, 2026	Details
ARTIS icono ceiling. Model Number: 11328100. 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.	FDA Z-2648-2026	Medical Device	High	Jul 8, 2026 Recall: Jun 8, 2026	Details
CRE Pro Wireguided 10-12mm 240cm Potential sterile breach of the pouches in which devices are packaged.	FDA Z-2628-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
RayCare 2024A SP4. Oncology Information Systems. 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.	FDA Z-2647-2026	Medical Device	High	Jul 8, 2026 Recall: May 20, 2026	Details
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 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.	FDA Z-2534-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.	FDA Z-2612-2026	Medical Device	High	Jul 8, 2026 Recall: May 28, 2026	Details
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 PACK 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.	FDA Z-2537-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.	FDA Z-2550-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
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 Dual-Lumen UDI-DI Code: 00801741223020 CK001066 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741228544 CK001068 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741228728 S1173108D PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741130342 S1173108D1 PowerPICC Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.	FDA Z-2664-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
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, subclavian, or femoral vein. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.	FDA Z-2657-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
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-DI Code: 00801741153952 S4153108DCP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741233258 S4153108DGP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154027 S4254108BD Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154140 S4254108BDP Provena Midline Ca Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.	FDA Z-2667-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710 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.	FDA Z-2540-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
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) PRESSURE INJ. CVC INSERTION BUNDLE, Model Number: ECVC1720; 7) DIALYSIS CATHETER INSERTION KIT, Model Number: CVI4815; 8) MULTIMED 7FR, 20CM, 3L CVC BUNDLE, Model Number: STCVC04; 9) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 10) ARTERIAL LINE TRAY, Model Number: ART350; 11) CVC INSERTION BU 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.	FDA Z-2541-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
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: 00801741108754 P4154108D PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108761 The PowerMidline" Catheter is intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.	FDA Z-2662-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL LINE TOTE DYNJ8407 Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.	FDA Z-2608-2026	Medical Device	High	Jul 8, 2026 Recall: May 28, 2026	Details
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). 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.	FDA Z-2603-2026	Medical Device	High	Jul 8, 2026 Recall: May 20, 2026	Details
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557 Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.	FDA Z-2649-2026	Medical Device	High	Jul 8, 2026 Recall: Jun 1, 2026	Details
Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.	FDA Z-2611-2026	Medical Device	High	Jul 8, 2026 Recall: May 28, 2026	Details
Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST BIOPSY PACK, Model Number: PHS234706I 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.	FDA Z-2539-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; 2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number: I505BF9C 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.	FDA Z-2538-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details
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-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107191 5865200 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI_DI Code: 00801741107214 5865240 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.	FDA Z-2661-2026	Medical Device	High	Jul 8, 2026 Recall: May 21, 2026	Details

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