Browse recalls
Issuing authority: US FDA — Medical Devices
- 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Medline Kit Number/SKU DYNJ37378A - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU DYNJ53820B - 2026-05-04 · US FDA — Medical DevicesClass II
SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.0 - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302 - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN - 2026-05-04 · US FDA — Medical DevicesClass I
Pediatric care bed; Product Designation: KayserBett IDA; - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Product Number/SKU (RE - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253A - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839 - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medline Kit Number/SKU DYNJ63789A; 2) CORONAR - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044 - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C; 2) UR - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PA - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medli - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C; 2) PK CUST CV A&B CA - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2 - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND18350 - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYNC1816, - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) D - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents f - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRANI, Medline Kit Numbe - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CD - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: DR FERNANDEZ, Medline kit number/SKU DYNJ68808 - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Number/SKU DYNJ65199A - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU DYNJ912271; 2) CV PACK PART 1, Me - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775I; 2) RETINA LAC/ - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline Product Number/SKU (RE - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TR - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. - 2026-05-01 · US FDA — Medical DevicesClass II
Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500 - 2026-05-01 · US FDA — Medical DevicesClass II
Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models - 2026-05-01 · US FDA — Medical DevicesClass II
Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant war - 2026-04-30 · US FDA — Medical DevicesClass II
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), - 2026-04-30 · US FDA — Medical DevicesClass II
Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR T - 2026-04-30 · US FDA — Medical DevicesClass I
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY - 2026-04-30 · US FDA — Medical DevicesClass I
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK - 2026-04-30 · US FDA — Medical DevicesClass I
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF - 2026-04-30 · US FDA — Medical DevicesClass II
Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04. - 2026-04-28 · US FDA — Medical DevicesClass II
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 ( - 2026-04-28 · US FDA — Medical DevicesClass II
Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integ - 2026-04-28 · US FDA — Medical DevicesClass II
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura X - 2026-04-28 · US FDA — Medical DevicesClass II
Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 - 2026-04-27 · US FDA — Medical DevicesClass I
BD Spinal Tray with BD Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose ( - 2026-04-27 · US FDA — Medical DevicesClass I
BD Spinal Tray with BD Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8 - 2026-04-27 · US FDA — Medical DevicesClass I
BD Spinal Tray with BD Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose ( - 2026-04-27 · US FDA — Medical DevicesClass I
BD Spinal Tray with BD Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose ( - 2026-04-27 · US FDA — Medical DevicesClass I
BD Spinal Tray with BD Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8 - 2026-04-27 · US FDA — Medical DevicesClass II
PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050 - 2026-04-27 · US FDA — Medical DevicesClass I
BD Spinal Tray with BD Whitacre Needle 25 G x 3.5 in., BD Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupiv - 2026-04-27 · US FDA — Medical DevicesClass I
BD Spinal Tray with BD Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose ( - 2026-04-27 · US FDA — Medical DevicesClass I
BD Spinal Tray with BD Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8 - 2026-04-27 · US FDA — Medical DevicesClass I
BD Spinal Tray with BD Whitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose ( - 2026-04-27 · US FDA — Medical DevicesClass I
BD Spinal Tray with BD Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose ( - 2026-04-24 · US FDA — Medical DevicesClass II
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in - 2026-04-24 · US FDA — Medical DevicesClass II
Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta Injection System; - 2026-04-24 · US FDA — Medical DevicesClass II
GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAP - 2026-04-24 · US FDA — Medical DevicesClass II
GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction - 2026-04-24 · US FDA — Medical DevicesClass II
CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3 - 2026-04-24 · US FDA — Medical DevicesClass II
GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemet - 2026-04-24 · US FDA — Medical DevicesClass II
GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-0 - 2026-04-24 · US FDA — Medical DevicesClass II
GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with Apex - 2026-04-23 · US FDA — Medical DevicesClass II
OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X - 2026-04-22 · US FDA — Medical DevicesClass II
Da Vinci ASSY, PSS, SP1098, Part Number: 380601 - 2026-04-22 · US FDA — Medical DevicesClass II
Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGB - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501; EP - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3L 12 FR X 16 CM/ASK-12123-UOC1, AHDC KIT - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: PARACENTESIS KIT/ASK-00376-JHH - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRA - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2L 5.5 FR X 50 CM/ASK-45052-NS - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-127 - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: ACCESS TRAY/ASK-04001-MC3 - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW; ARTERIAL LINE KIT: S - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/AK-15123-PCDC; AHDC KIT: 3-L - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; SPINAL ANESTHESIA KIT/ASA-25090 - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: PICC ACCESS TRAY/ASK-04001-CG1 - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM W CHG/SAC-01218-C; SAC KIT: 18 GA X 16CM - 2026-04-21 · US FDA — Medical DevicesClass II
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310 - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MIDLINE 1L: 4.5FR X 15CM/CDC-41541-MPK1A; A - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000 - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-L - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A; ARTERIAL CATHETER - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB- - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU5; PSI KIT: 8.5 FR/A - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT: 14 GA X 6 IN/CK-0471 - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA X 1 1/2IN/NA-04220-S1A; ARTERIAL LINE K - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU4; - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM, THORACENTESIS KIT/AK-01000-T, - 2026-04-21 · US FDA — Medical DevicesClass I
PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK- - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DE - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PNHS2; - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122; - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-4556