Browse recalls
Alert level: Class I
- 2026-09-24 · US FDA — Medical DevicesClass I
Philips Lumify Diagnostic Ultrasound System - 2026-09-18 · US FDA — Medical DevicesClass I
Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pu - 2026-09-18 · US FDA — Medical DevicesClass I
Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pu - 2026-09-18 · US FDA — Medical DevicesClass I
Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart p - 2026-08-14 · US FDA — Medical DevicesClass I
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED, MANUAL, MEDLITE - 2026-08-14 · US FDA — Medical DevicesClass I
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/ MDR107002E - 2026-08-11 · US FDA — Medical DevicesClass I
Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A - 2026-08-11 · US FDA — Medical DevicesClass I
Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A - 2026-08-11 · US FDA — Medical DevicesClass I
Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A - 2026-08-11 · US FDA — Medical DevicesClass I
Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catalog Number: - 2026-08-11 · US FDA — Medical DevicesClass I
Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100, Catalog Number: DYNDB3100; 3) DYNDH - 2026-08-11 · US FDA — Medical DevicesClass I
Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A, Catalog Number: ACC010374A; 3) - 2026-08-11 · US FDA — Medical DevicesClass I
Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2) ARTERIAL LINE ST JOES SYR PACK - 2026-08-11 · US FDA — Medical DevicesClass I
INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Mod - 2026-08-11 · US FDA — Medical DevicesClass I
INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Nu - 2026-08-06 · US FDA — Medical DevicesClass I
Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product - 2026-07-30 · US FDA — Medical DevicesClass I
BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D01525 - 2026-07-29 · US FDA — Medical DevicesClass I
StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system. - 2026-07-29 · US FDA — Medical DevicesClass I
StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system. - 2026-07-29 · US FDA — Medical DevicesClass I
StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system. - 2026-07-29 · US FDA — Medical DevicesClass I
StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system. - 2026-07-29 · US FDA — Medical DevicesClass I
StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system. - 2026-07-06 · US FDA — Medical DevicesClass I
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Cat - 2026-06-17 · US FDA — Medical DevicesClass I
INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Cod - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Tap - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pum - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessori - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Tap - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-300 - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessori - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006- - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-30 - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. h - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer P - 2026-06-05 · US FDA — Medical DevicesClass I
MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G - 2026-06-05 · US FDA — Medical DevicesClass I
MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; m - 2026-06-05 · US FDA — Medical DevicesClass I
MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2) TOTAL KNEE BASIC, Medline Ki - 2026-05-29 · US FDA — Medical DevicesClass I
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 - 2026-05-21 · US FDA — Medical DevicesClass I
Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung E - 2026-05-21 · US FDA — Medical DevicesClass I
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung - 2026-05-21 · US FDA — Medical DevicesClass I
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expa - 2026-05-21 · US FDA — Medical DevicesClass I
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Exp - 2026-05-21 · US FDA — FoodClass I
Boner Bears CHOCOLATE, 3 DOSES PER BAR, NET WT. 22g, MALE ENHANCEMENT, DOSAGE: Consume 1 piece at least 1 hour prior to - 2026-05-20 · US FDA — Medical DevicesClass I
Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-67 - 2026-05-20 · US FDA — Medical DevicesClass I
Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). - 2026-05-20 · US FDA — Medical DevicesClass I
Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). 2. - 2026-05-15 · US FDA — Medical DevicesClass I
Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagno - 2026-05-08 · US FDA — Medical DevicesClass I
Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 20826 - 2026-05-08 · US FDA — Medical DevicesClass I
Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Pro - 2026-05-08 · US FDA — Medical DevicesClass I
Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M109 - 2026-05-06 · US FDA — Medical DevicesClass I
Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), B - 2026-05-06 · US FDA — Medical DevicesClass I
Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2) DYNJ905503G, Model Number: C - 2026-05-06 · US FDA — Medical DevicesClass I
Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2) OPEN HEART A OVERHEAD, Model - 2026-05-06 · US FDA — Medical DevicesClass I
Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867 - 2026-05-06 · US FDA — Medical DevicesClass I
Medline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ACC011142; 2) CENTRAL AND ARTERIAL LINE T - 2026-05-06 · US FDA — Medical DevicesClass I
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART, Model Number: CDS840150W; 3) - 2026-05-06 · US FDA — Medical DevicesClass I
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 - 2026-05-06 · US FDA — Medical DevicesClass I
Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C - 2026-05-04 · US FDA — Medical DevicesClass I
Pediatric care bed; Product Designation: KayserBett IDA; - 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 - 2026-04-27 · 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 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 ( - 2026-04-23 · US FDA — FoodClass I
french broad CHOCOLATE bette's bake sale (a multi-flavor bonbon assortment). 6-piece NET WT. 2.5 OZ (70.75G); 12-piece N - 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 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