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FDA Device Enforcement Reports
View 10000 FDA Device Enforcement Reports on BEUDAMED, the Better Database on Medical Devices. These records compile FDA actions such as recalls, safety alerts, market withdrawals, and warning letters related to medical devices regulated in the United States. Each entry lists device identifiers, manufacturer information, enforcement dates, and the reason for the action to support quick assessment.
FDA Device Enforcement Reports help clinicians, manufacturers, and health-system buyers assess device safety and regulatory status. Use BEUDAMED to monitor trends, compare enforcement activity across device types, and export data for quality and compliance reviews. Regular review of enforcement reports supports post-market surveillance and informed procurement decisions.
Medline convenience kits: C-SECTION KIT DYNJ904305J C-SECTION PACK DYNJ69533C
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·June 24, 2026
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
FDA Enforcement
Class II
·Ongoing·Medtronic Navigation, Inc.-Boxborough·June 24, 2026
Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire¿ Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A
FDA Enforcement
Class II
·Ongoing·Inspire Medical Systems Inc.·June 24, 2026
MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medline Kit/SKU DYNJ911589A; 3) CAROTID ENDARTECOMY, Medline Kit/SKU DYNJ36211D; 4) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973; 5) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973A; 6) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879; 7) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879C; 8) FEM POP CDS, Medline Kit/SKU CDS983670K; 9) LAP BASIN TRAY, Medline Kit/SKU DYNJ50908B; 10) OPEN HEART LTX CATHETERS KIT, Medline Kit/SKU DYNJ0049032A; 11) OPEN HEART PACK, Medline Kit/SKU DYNJ80549C; 12) OPEN HEART PACK, Medline Kit/SKU DYNJ80549D; 13) RR-ADULT ECMO PACK, Medline Kit/SKU DYNJ69742B; 14) TAVR, Medline Kit/SKU DYNJ906509C.
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·June 24, 2026
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: 3-L 12 FR X 16 CM/ASK-12123-UPM, AHDC KIT: 3L 12 FR X 20 CM/ASK-15123-UOC1, AHDC KIT: 3-L 12 FR X 20 CM/ASK-15123-UPM, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-P1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XP1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XPCN1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XPN1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-P1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XPCN1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XPN1A, AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XPCN1A, HEMODIALYSIS KIT 2L: 12 FR X 20CM AGB/AK-25122-CDC, HEMODIALYSIS KIT: 2-LUMEN 14 FR X 20 CM/AK-25142-F, HEMODIALYSIS KIT: 2L 12 FR X 6 IN/ASK-22122-MM1, HEMODIALYSIS KIT: 2L 12 FR X 6 IN/ASK-22122-MM2, AHDC KIT: 2L 14 FR X 15 CM/ASK-22142-UOC1, AHDC AGB KIT: 2-L 14 FR X 15 CM/ASK-22142-UPM, HEMODIALYSIS KIT: 2L 14 FR X 20 CM/ASK-25142-UNC1, AHDC KIT: 2L 14 FR X 20 CM/ASK-25142-UOC1, AHDC AGB KIT: 2L 14 FR X 20 CM/ASK-25142-UPM, HEMODIALYSIS KIT 2L: 14 FR X 25 CM AGB/ASK-26142-UNC1, HEMODIALYSIS KIT: 2LUMEN 12 FR X 16 CM/AU-22122-F, HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-XCN1A-U, AHDC AGB KIT: 2-L 12 FR X 16 CM/CDC-22122-XN1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-XN1A-U, HEMODIALYSIS KIT 2L: 14 FR X 15 CM AGB/CDC-22142-1A, HEMODIALYSIS KIT: 2L 14 FR X 15 CM AGB/CDC-22142-XC1A, AHDC AGB KIT: 2-L 14 FR X 15 CM/CDC-22142-XCN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-XCN1A-C, AHDC AGB KIT: 2-L 14 FR X 15 CM/CDC-22142-XN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-XN1A-C, AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-XCN1A-U, AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-XN1A-U, HEMODIALYSIS KIT: 2L 12 FR X 13 CM AGB/CDC-23122-XU1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-X1A, AHDC AGB KIT: 2-L 12 FR X 20 CM/CDC-25122-XCN1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-XCN1A-U, AHDC AGB KIT: 2-L 12 FR X 20 CM/CDC-25122-XN1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-XU1A, HEMODIALYSIS KIT 2L: 14 FR X 20 CM AGB/CDC-25142-1A, HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB/CDC-25142-XC1A, AHDC AGB KIT: 2-L 14 FR X 20 CM/CDC-25142-XCN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-XCN1A-C, AHDC AGB KIT: 2-L 14 FR X 20 CM/CDC-25142-XN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-XN1A-C, HEMODIALYSIS KIT: 2L 12 FR X 25 CM AGB/CDC-26122-1A, AHDC AGB KIT: 2-L 12 FR X 25 CM/CDC-26122-XCN1A, AHDC AGB KIT: 2-L 12 FR X 25 CM/CDC-26122-XN1A, HEMODIALYSIS KIT 2L: 14 FR X 25 CM AGB/CDC-26142-1A, HEMODIALYSIS KIT: 2L 14 FR X 25 CM AGB/CDC-26142-X1A, AHDC AGB KIT: 2-L 14 FR X 25 CM/CDC-26142-XCN1A, AHDC AGB KIT: 2-L 14 FR X 25 CM/CDC-26142-XN1A, HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-25122-F, AHDC AGB KIT: 2-L 12 FR X 16 CM/CDC-22122-XCN1A, LBCVC AGB KIT: 3-L 12 FR X 16 CM/CDC-22123-XCN1A, LBCVC AGB KIT: 3-L 12 FR X 20 CM/CDC-25123-XCN1A, LBCVC AGB KIT:3-L 12 FR X 20 CM/CDC-25123-XN1A
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026
Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501; EPIDURAL CATHETERIZATION KIT/AK-05502; EPIDURAL CATHETERIZATION KIT/AK-05502D; EPIDURAL CATHETERIZATION KIT/AK-05503; EPIDURAL CATHETERIZATION KIT/AK-05503-L; SPINAL ANES/EPIDURAL CATH KIT/AK-05560; SPINAL ANES/EPIDURAL CATH KIT/ASK-02520-SBMC1; EPIDURAL CATHETERIZATION KIT/ASK-05400-BW1; EPIDURAL CATHETERIZATION KIT/ASK-05400-GH; SPINAL ANES/EPIDURAL CATH KIT/ASK-05401-LMC; EPIDURAL CATHETERIZATION KIT/ASK-05401-NM; SPINAL ANES/EPIDURAL CATH KIT/ASK-05500-BID1; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-JHH1; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-MCV1; EPIDURAL CATHETER KIT: 19GA X 90CM ASK-05500-MVH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05500-UMC; 19 GA X 35.5 IN EPIDURAL CATHETER KIT/ASK-05502-MLH; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-JMH1; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-MKD2; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-OM1; EPIDURAL CATHETERIZATION KIT/ASK-17019-SM; EPIDURAL CATHETERIZATION KIT/BP-05501; EPIDURAL CATHETERIZATION KIT/CK-05401; EPIDURAL CATHETERIZATION KIT/HS-05501; EPIDURAL CATHETERIZATION KIT/MM-05501; EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TK; EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TKD; EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TKL; EPIDURAL CATHETERIZATION KIT/MSO-05401-JMH; EPIDURAL CATHETERIZATION KIT/NM-05401; EPIDURAL CATHETERIZATION KIT/SJ-05501; EPIDURAL CATHETERIZATION KIT/SM-05401; EPIDURAL CATHETER KIT: 19 GA X 90 CM/TM-05401; EPIDURAL CATHETERIZATION KIT/TM-05502; SPINAL ANES/EPIDURAL CATH KIT/UI-05502; SPINAL ANES/EPIDURAL CATH KIT: 19 GA/ASK-05400-SHM; EPIDURAL CATH KIT: 19 GA/ASK-05400-UOM; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05500-MR; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-TM; EPIDURAL CATHETERIZATION KIT/ASK-05501-BHL1; EPIDURAL CATHETERIZATION KIT/ASK-05501-GH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-SM; EPIDURAL CATHETERIZATION KIT/ASK-05502-BSM; EPIDURAL CATHETERIZATION KIT/ASK-05502-MGH1; EPIDURAL CATHETERIZATION KIT/ASK-05503-BWB1; EPIDURAL CATHETERIZATION KIT/ASK-05503-HMH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05503-SPH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05503-UPM1; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-UCI2; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-17019-UMP; EPIDURAL CATHETERIZATION KIT/MH-05503-1; EPIDURAL CATHETERIZATION KIT/ASK-05401-VB2; Epidural Catheterization Kit: 19GA/ASK-05500-SC1; Epidural Catheterization Kit: 19GA/ASK-05500-SC3; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-AFH1; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-BMC; EPIDURAL CATHETERIZATION KIT/ASK-05502-NY; EPIDURAL CATHETERIZATION KIT/ASK-17019-RMH
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026
MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B; 3) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483C; 4) CV DRAPING/BASIN 2PART PACK, Medline Kit Number/SKU DYNJ89414; 5) CVG BASIN PACK SC, Medline Kit Number/SKU DYNJ38052G; 6) T/A BASIN SET, Medline Kit Number/SKU DYNJ47941F; 7) VALVE BASIN PACK SC, Medline Kit Number/SKU DYNJ38054G.
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·June 24, 2026
ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS12-120LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
FDA Enforcement
Class II
·Ongoing·ConMed Corporation·June 24, 2026
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
FDA Enforcement
Class I
·Ongoing·Abiomed, Inc.·June 24, 2026
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 (10 CM)/ASK-09810-PCMH1; PSI KIT: 9 FR X 10 CM/ASK-09903-KH; PSI KIT: 9 FR X 10 CM/ASK-09903-PHP1; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-UPA; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-YNH; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09907-SL; PSI KIT: 8.5 FR X 4-1/8IN (10 CM)/NA-09803-CDC; PSI KIT: 9 FR X 4-1/8IN (10 CM)/NA-09903-CDC; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-ECL4; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-MGH3; MULTI-LUMEN/PSI KIT/AK-11142-SPCS; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM/CDC-11242-1A; MULTI-LUMEN/PSI KIT/AK-11142-D; MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-11142-MGH4; MULTI-LUMEN/PSI KIT/NA-11242-CDC; MULTI-LUMEN/PSI KIT/AK-21142-SK; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-LMDTG; MULTI LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-RH; MULTILUMEN/PSI KIT 9 FR X 11.5 CM/ASK-21242-IMC; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/ASK-21242-LMDTG; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMD; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UU3; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-VCU; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-1A; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-X1A; MULTI-LUMEN/PSI KIT/AK-21242-CDC; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-FH4; MULTI LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-GH1; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-SUU; 2-L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-UPMC4; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UKL; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMF; MULTILUMEN/PSI KIT: 9 FR X 4 1/2 IN/ASK-21242-UR1; PSI KIT: 8.5 FR/AK-29803-CDC; PSI KIT: 9 FR/AK-29903-CDC; PSI KIT: 9 FR/AK-29907-CDC; PSI KIT: 8.5 FR X 4IN (10 CM)/ASK-09804-UN1; PSI KIT: 9 FR/ASK-09903-UM; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-LMDT; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-LMDTG; PSI KIT: 9 FR X 4 1/8 (10 CM)/ASK-29903-BID1; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-LMDTG; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UMD; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-UR1; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-X1A; PSI KIT: 8.5 FR X 10 CM/ASK-29803-ECL; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-UPM3; PSI KIT: 9 FR X 10 CM/ASK-29903-ECL; PSI KIT: 9FR X 4IN (10 CM) ANTIMICROBIAL/ASK-29903-UPM3; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09907-TG1
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026