Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2026-04-15FDA-DeviceCook IncorporatedClass IICOOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 2026-04-15FDA-DeviceCook IncorporatedClass IICOOK 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.
- 2026-04-15FDA-DeviceCook IncorporatedClass IICOOK 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.
- 2026-04-15FDA-DeviceCook IncorporatedClass IICOOK 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.
- 2026-04-15FDA-DeviceCook IncorporatedClass IICOOK 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-UDL
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 2026-04-15FDA-DeviceCook IncorporatedClass IICOOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 2026-04-15FDA-DeviceCook IncorporatedClass IICOOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 2026-04-15FDA-DeviceCook IncorporatedClass IIMelker 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.
- 2026-04-15FDA-DeviceCook IncorporatedClass IICOOK 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.
- 2026-04-15FDA-DeviceCook IncorporatedClass IICOOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Number G21053; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, Order Number G34914; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0047, Order Number G44431; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0048, Order Number G44432.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 2026-04-15FDA-DeviceCook IncorporatedClass IICOOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 2026-04-15FDA-DeviceCook IncorporatedClass IICOOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 2026-04-15FDA-DeviceCook IncorporatedClass IICOOK 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.
- 2026-04-15FDA-DeviceCook IncorporatedClass IICOOK 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.
- 2026-04-15FDA-DeviceCook IncorporatedClass IICOOK 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.
- 2026-04-15FDA-DeviceCook IncorporatedClass IICOOK 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.
- 2026-04-15FDA-DeviceCook IncorporatedClass IICOOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 2026-04-15FDA-DeviceCook IncorporatedClass IICOOK 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.
- 2026-04-15FDA-DeviceMolded Products IncClass IISee 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.
- 2026-04-15FDA-DeviceXTANT Medical Holdings, IncClass IIXTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
- 2026-04-15FDA-DeviceBeckman Coulter, Inc.Class IIMicroScan Neg MIC 3J REF C54814
Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
- 2026-04-15FDA-DeviceTornier, IncClass IITornier 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.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. SHOULDER ARTHROSCOPY PACK, Medline SKU # DYNJ30880M; 2. EXTREMITY PACK, Medline SKU # DYNJ64295A.
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.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: TAVR PACK, Medline SKU # DYNJ84472
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.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IMedline 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.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. DELIVERY PACK, Medline SKU # DYNJ42892F; 2. DELIVERY PACK, Medline SKU # DYNJ42892G.
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.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ANGIO PACK, Medline SKU # DYNJ57032D; 2. NEURO INTERVENTIONAL RADIOLOGY, Medline SKU # DYNJ64026C; 3. NEURO INERVENTIONAL RADIOLOGY, Medline SKU # VASC1650.
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.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: GLOVE PACK 7.0 (15PK), Medline SKU # DYNJ63673D
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.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. MTS RH LFT HRT KIT, Medline SKU # 60010508; 2. MTS 3V W/GUIDE, Medline SKU # 60100701; 3. ANGIOGRAPHY KIT, Medline SKU # 60131209; 4. MTS LHK, Medline SKU # 60160075; 5. MTS LHK, Medline SKU # 60161954; 6. MTO LHK, Medline SKU # 60230148; 7. GENERAL SURGERY TRAY, Medline SKU # 00-500510I; 8. BIOBURDEN TEST KIT - 686, Medline SKU # BIO
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.
- 2026-04-15FDA-DeviceMedline Industries, LPClass IMedline 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.
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