Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 901 - 925 of 1,678 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Reference Part Number C-PTIS-100-UNS-HC-G-EU, Order Number G57686. Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	FDA Z-1779-2026	Medical Device	High	Apr 15, 2026 Recall: Mar 5, 2026	Details
Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252 Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.	FDA Z-1769-2026	Medical Device	High	Apr 15, 2026 Recall: Mar 5, 2026	Details
See Luer Cap Set, MPC-130, set, administration, intravascular Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set based on a confirmed complaint of the threaded sleeve not being engaged and becoming un-attached.	FDA Z-1774-2026	Medical Device	High	Apr 15, 2026 Recall: Feb 17, 2026	Details
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: MINOR PLASTIC-LF, Medline Kit SKU # DYNJ86596 Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.	FDA Z-1723-2026	Medical Device	High	Apr 15, 2026 Recall: Feb 27, 2026	Details
MicroScan Neg MIC 3J REF C54814 Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics	FDA Z-1772-2026	Medical Device	High	Apr 15, 2026 Recall: Jun 25, 2025	Details
COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242 Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	FDA Z-1790-2026	Medical Device	High	Apr 15, 2026 Recall: Mar 5, 2026	Details
NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline S Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.	FDA Z-1718-2026	Medical Device	High	Apr 15, 2026 Recall: Feb 27, 2026	Details
COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786 Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	FDA Z-1775-2026	Medical Device	High	Apr 15, 2026 Recall: Mar 5, 2026	Details
COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, Order Number G43986; Reference Part Number C-UDLM-401J-PED-ABRM-HC, Order Number G43984; Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, Order Number G24752; Reference Part Number C-UDLM-401J-RSC-ABRM-HC, Order Number G43985; Reference Part Number C-UDLM-501J-ABRM-HC, Order Number G43995; Reference Part Number C-UDLM-501J-PED-ABRM-HC, Order Number G43996; Referenc Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	FDA Z-1788-2026	Medical Device	High	Apr 15, 2026 Recall: Mar 5, 2026	Details
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700. During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.	FDA Z-1653-2026	Medical Device	High	Apr 15, 2026 Recall: Mar 10, 2026	Details
COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800; Reference Part Number C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, Order Number G44809; Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, Order Number G44806; Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-IHI-FST-A-RD, Order Number G44807. Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	FDA Z-1789-2026	Medical Device	High	Apr 15, 2026 Recall: Mar 5, 2026	Details
Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solution Color Cuff 18" (Red), Quick Connect Dual Port Single Bladder REF 5921-018-135 Stryker Sustainability Solution Color Cuff 18" (Red) Dual Port Single Bladder REF 5921-018-235. Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.	FDA Z-1804-2026	Medical Device	High	Apr 15, 2026 Recall: Mar 12, 2026	Details
B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting steps to resolve. If Quality Controls are not performed according to the Instructions for Use, the underestimation of QC1 may go undetected and could contribute to falsely elevated sFlt-1/PlGF ratio results. A falsely elevated sFlt-1/PlGF ratio may result in a higher-risk classification for progression to preeclampsia with severe features potentially leading to intensified clinical monitoring.	FDA Z-1795-2026	Medical Device	High	Apr 15, 2026 Recall: Mar 12, 2026	Details
COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792 Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	FDA Z-1777-2026	Medical Device	High	Apr 15, 2026 Recall: Mar 5, 2026	Details
NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline S Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.	FDA Z-1712-2026	Medical Device	High	Apr 15, 2026 Recall: Feb 27, 2026	Details
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ROBOTIC PACK, Medline SKU # DYNJ58475F; 2. URO/GEN ROBOTIC PACK, Medline SKU # DYNJ60803J. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.	FDA Z-1728-2026	Medical Device	High	Apr 15, 2026 Recall: Feb 27, 2026	Details
COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704. Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	FDA Z-1780-2026	Medical Device	High	Apr 15, 2026 Recall: Mar 5, 2026	Details
COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535. Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	FDA Z-1791-2026	Medical Device	High	Apr 15, 2026 Recall: Mar 5, 2026	Details
COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108 Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	FDA Z-1784-2026	Medical Device	High	Apr 15, 2026 Recall: Mar 5, 2026	Details
Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665. Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	FDA Z-1785-2026	Medical Device	High	Apr 15, 2026 Recall: Mar 5, 2026	Details
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: SPECIAL PROCEDURE TRAY, Medline SKU # DYNJ80513B Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.	FDA Z-1720-2026	Medical Device	High	Apr 15, 2026 Recall: Feb 27, 2026	Details
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: CVOR ANGIOGRAPHY PACK-LF, Medline SKU DYNJ42367B Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.	FDA Z-1714-2026	Medical Device	High	Apr 15, 2026 Recall: Feb 27, 2026	Details
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CATH LAB PACK-LF, Medline SKU 00-HCT055P; 2. INTERVENTIONAL CATH LAB PK-LF, Medline SKU DYNJ0376230Q; 3. ANGIOGRAPHY CATH LAB, Medline SKU DYNJ23532C; 4. ANGIO LEFT HEART PACK, Medline SKU DYNJ40632C; 5. ANGIO DRAPE PACK, Medline SKU DYNJ47952B; 6. ANGIOGRAPHIC PACK, Medline SKU DYNJ57516; 7. CATH LAB PACK, Medline SKU DYNJ58243B; 8. CATH LAB PACK, Medline SKU DYNJ65185; 9. CSU CATH MANIFOLD KIT, Medline SKU VASC1170A; 10. MANIFOLD KIT NO TRANSDUCER Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.	FDA Z-1716-2026	Medical Device	High	Apr 15, 2026 Recall: Feb 27, 2026	Details
NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; 2. SYRINGE,8ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70084007; 3. MTS,SYRINGE,8ML,TR/FR,RA,NO,RES,-,P/G, Medline SKU 70084017; 4. SYRINGE,7,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80083007; 5. SYRINGE,8,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80084007; 6. MTO,SYRINGE,8,ML,TR/FR,RA,NO,RES,OEM,PG, Medline SKU 80084017. Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.	FDA Z-1713-2026	Medical Device	High	Apr 15, 2026 Recall: Feb 27, 2026	Details
COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419 Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	FDA Z-1778-2026	Medical Device	High	Apr 15, 2026 Recall: Mar 5, 2026	Details

Showing 901 - 925 of 1,678 product recalls

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