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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 181–200 of 1,000 recalls

Class IIOngoing

SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02

Micromed S.p.A.

Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channels) running firmware version 2022.02 were displayed with a shift of 1 second between the 64channels blocks. In rare circumstances, a fixed 1-second temporal delay may appear between two 64-channel modules with firmware 2021.02, 2022.01 or 2022.02 in a multi-module SEEG configuration, potentially leading to misinterpretation of results.

May 4, 2026 · DeviceView details →
Class IIOngoing

MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302

Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

May 4, 2026 · DeviceView details →
Class IIOngoing

MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN PACK, FS LAP TUBAL LIGATION, HILLSDALE D&C / HYSTEROSCOPY, LAVH NEW BRAUNFELS,TVH PACK, etc (see recall documents for a full list of affected products)

Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

May 4, 2026 · DeviceView details →
Class IOngoing

Pediatric care bed; Product Designation: KayserBett IDA;

KAYSERBETTEN GMBH & CO. KG

If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased risk that the patient (child) or third parties (children) will operate the hand control and trap themselves or others under the bed frame or between the bed frame and the floor. This can lead to serious injuries or even death of the patient (child) or third parties (children).

May 4, 2026 · DeviceView details →
Class IIOngoing

MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR16C

Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

May 4, 2026 · DeviceView details →
Class IIOngoing

MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253A

Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

May 4, 2026 · DeviceView details →
Class IIOngoing

MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839

Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

May 4, 2026 · DeviceView details →
Class IIOngoing

MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medline Kit Number/SKU DYNJ63789A; 2) CORONARY/ARTERY BYPASS TRAY, Medline Kit Number/SKU DYNJ17321G; 3) D&C/CYSTO, Medline Kit Number/SKU DYNJ909989B; 4) DDD LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53214; 5) DIAGNOSTIC LAPAROSCOPY, Medline Kit Number/SKU DYNJ903390K; 6) GENERAL LAPAROSCOPY, Medline Kit Number/SKU DYNJ902700C; 7) GENERAL LAPAROSCOPY, Medline Kit Number/SKU DYNJ902700D; 8) GENERAL LAPAROSCOPY, Medline Kit Number/SKU DYNJ902700F; 9) GENERAL-CVOR MINOR, Medline Kit Number/SKU DYNJ64324A; 10) GYN LAP, Medline Kit Number/SKU DYNJT7061; 11) GYN LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53631F; 12) GYN MINOR PACK, Medline Kit Number/SKU DYNJ85910; 13) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117A; 14) LAP, Medline Kit Number/SKU DYNJ904585B; 15) LAP, Medline Kit Number/SKU DYNJ904585C; 16) LAP CHOLE CDS, Medline Kit Number/SKU CDS983255R; 17) LAP CHOLE CDS, Medline Kit Number/SKU CDS983255S; 18) LAP CHOLE CDS, Medline Kit Number/SKU CDS983255T; 19) LAPAROSCOPY, Medline Kit Number/SKU DYNJ89908; 20) LAPAROSCOPY, Medline Kit Number/SKU DYNJ910517; 21) LAPAROSCOPY, Medline Kit Number/SKU DYNJ910517A; 22) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ06958I; 23) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ06958J; 24) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53992C; 25) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53992D; 26) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53992F; 27) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53992G; 28) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ53992I; 29) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ67160; 30) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ84211; 31) LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJHS0235C; 32) LAPAROSCOPY PACK VICTORY, Medline Kit Number/SKU DYNJ81148; 33) LAPAROSCOPY PK, Medline Kit Number/SKU DYNJ14073B; 34) LAPAROSCOPY PK, Medline Kit Number/SKU DYNJ61404A; 35) LAPAROSCOPY PK, Medline Kit Number/SKU DYNJ61404B; 36) LAPAROSCOPY PK, Medline Kit Number/SKU DYNJ61404C; 37) LAPAROSCOPY PK, Medline Kit Number/SKU DYNJ61404D; 38) LAPAROSCOPY/GYN PACK, Medline Kit Number/SKU DYNJ0384702U; 39) PACK LAPAROSCOPY, Medline Kit Number/SKU DYNJ0553254O; 40) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKU DYNJ908046A; 41) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKU DYNJ908046B; 42) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKU DYNJ908046C; 43) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKU DYNJ908046D; 44) PROCEDURE PACK DR BILIMORI, Medline Kit Number/SKU DYNJ908046F; 45) PROLAPSE PACK, Medline Kit Number/SKU DYNJ85390; 46) RICH CYSTO, Medline Kit Number/SKU DYNJ902183I; 47) RR-PEDS CHEST BLEEDER/ECMO PK, Medline Kit Number/SKU DYNJ66263B; 48) RR-PEDS CHEST BLEEDER/ECMO PK, Medline Kit Number/SKU DYNJ66263C; 49) SMJ LAPAROSCOPY PACK, Medline Kit Number/SKU DYNJ25763J; 50) WCH GENERAL LAPAROSCOPY, Medline Kit Number/SKU DYNJ902700G.

Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

May 4, 2026 · DeviceView details →
Class IIOngoing

MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044

Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

May 4, 2026 · DeviceView details →
Class IIOngoing

MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C; 2) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978; 3) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978F.

Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

May 4, 2026 · DeviceView details →
Class IIOngoing

MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PACK, FLOYD LAP GYN, GYN LAP PACK, GYN LAPAROSCOPY, GYN MINOR PACK, etc. (see the recall documents for a full list of affected products)

Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

May 4, 2026 · DeviceView details →
Class IIOngoing

MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medline Kit Number/SKU DYNJ912219; 3) KIT MAJ VAG SET UP, Medline Kit Number/SKU DYNJ907033B; 4) MINOR VAG PACK, Medline Kit Number/SKU DYNJ68663B; 5) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099F; 6) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099G; 7) OB PACK, Medline Kit Number/SKU DYNJ03387B; 8) OB PACK, Medline Kit Number/SKU DYNJ03387C; 9) OB PACK, Medline Kit Number/SKU DYNJ53543B; 10) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645D; 11) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645F; 12) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645G; 13) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454K; 14) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454L; 15) VAGINAL PACK, Medline Kit Number/SKU DYNJ01830G.

Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

May 4, 2026 · DeviceView details →
Class IIOngoing

MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C; 2) PK CUST CV A&B CABRINI CO, Medline Kit Number/SKU DYNJ60583C.

Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

May 4, 2026 · DeviceView details →
Class IIOngoing

MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2. DYND13510 - 10 Fr; 3. DYND13512 - 12 Fr; 4. DYND13514 - 14 Fr; 5. DYND13515 - 15 Fr; 6. DYND13516 - 16 Fr; 7. DYND13518 - 18 Fr; 8. DYND13520 - 20 Fr; 9. DYND13522 - 22 Fr; 10. DYND13614 - 14 Fr; 11. DYND13616 - 16 Fr.

Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

May 4, 2026 · DeviceView details →
Class IIOngoing

MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND18350

Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

May 4, 2026 · DeviceView details →
Class IIOngoing

MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYNC1816, 15 Fr; 2. DYND10350, 15 Fr.

Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

May 4, 2026 · DeviceView details →
Class IIOngoing

MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND10407

Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

May 4, 2026 · DeviceView details →
Class IIOngoing

MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products)

Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

May 4, 2026 · DeviceView details →
Class IIOngoing

MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRANI, Medline Kit Number/SKU DYNJ908097A; 3) CRANI, Medline Kit Number/SKU DYNJ908097B; 4) CRANI, Medline Kit Number/SKU DYNJ908097C; 5) CRANI, Medline Kit Number/SKU DYNJ908097D; 6) DR TUCKER ANT TOTAL HIP, Medline Kit Number/SKU DYNJ912029; 7) JEWISH CRANI PACK, Medline Kit Number/SKU DYNJ55637B; 8) L SCOPE PACK, Medline Kit Number/SKU DYNJ43930A; 9) LAMI PACK, Medline Kit Number/SKU DYNJ67767; 10) LAVH NEW BRAUNFELS, Medline Kit Number/SKU DYNJ61136F; 11) SOI KNEE ARTHROSCOPY, Medline Kit Number/SKU DYNJV0172Q; 12) T AND A PACK, Medline Kit Number/SKU DYNJ86229.

Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

May 4, 2026 · DeviceView details →
Class IIOngoing

MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CDS, Medline Kit Number/SKU CDS983800J; 3) VP SHUNT CDS, Medline Kit Number/SKU CDS983800K.

Medline Industries, LP

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

May 4, 2026 · DeviceView details →
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