Latest device recalls
Newest first, 50 per page. Open a recall to see the 510(k) clearances it names.
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | ICU Medical, Inc. IV Sets with drip chambers Open, Classified |
FMG | K964435 |
| Sep 11, 2026 | GE Medical Systems Information Technologies Inc Carescape Central Station
CSCS V3 MAS800 Desktop
Part Number 5867474-04, 5867474-13
Product code STU
CSCS V3 MAI800 Integrated
Part Number 5867474-03
Product Code STV Open, Classified |
DQK | K162012 |
| Sep 11, 2026 | Given Imaging Ltd. Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635,
Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used to attach a pH monitoring capsule to the esophagus. Open, Classified |
FFT | None listed |
| Sep 11, 2026 | Philips North America Philips PIC iX Essentials
REF:867093 Open, Classified |
MHX | K153702 |
| Sep 11, 2026 | Medline Industries, LP Medline Convenience Kit:
OPEN HEART A PACK, Product Number DYNJ43008N Open, Classified |
LRO | K213481 |
| Sep 11, 2026 | Bard Access Systems, Inc. DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150;
DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625200;
DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625240;
DuoGlide Short Open, Classified |
MPB | K030268 K090102 |
| Sep 11, 2026 | Philips North America Philips Patient Information Center iX
REF:866389 Open, Classified |
MHX | K153702 |
| Sep 11, 2026 | ICU Medical, Inc. IV Sets with drip chambers Open, Classified |
FRN | K141789 |
| Sep 11, 2026 | ICU Medical, Inc. IV Sets with drip chambers Open, Classified |
ONB | K131549 K170110 +1 |
| Sep 11, 2026 | ICU Medical, Inc. IV Sets with drip chambers Open, Classified |
FPA | K081361 K100576 +3 |
| Sep 11, 2026 | ICU Medical, Inc. Oncology sets with drip chambers Open, Classified |
ONB | K131549 K173477 |
| Sep 11, 2026 | ICU Medical, Inc. Oncology sets with drip chambers Open, Classified |
FPA | K081361 |
| Sep 11, 2026 | Nova Biomedical Corporation StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system. Open, Classified |
PZI | K232075 |
| Sep 11, 2026 | Nova Biomedical Corporation StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system. Open, Classified |
PZI | K232075 |
| Sep 11, 2026 | ICU Medical, Inc. IV Non-Dedicated Gravity Administration Sets with drip chambers Open, Classified |
FMG | K964435 |
| Sep 11, 2026 | Bard Access Systems, Inc. Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150;
Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605200;
Power-Trialysis Short-Term Straight Dialysis Catheter, REF: Open, Classified |
MPB | K133456 K141531 |
| Sep 11, 2026 | ICU Medical, Inc. Plum administration sets Open, Classified |
FPA | None listed |
| Sep 10, 2026 | Windstone Medical Packaging, Inc. AMS Convenience Kit:
DSAEK Pack - RX, Part Number AMS12394B Open, Classified |
KDD | None listed |
| Sep 10, 2026 | Nipro Renal Soultions USA, Corporation Citric Complete Liquid Citric Acid Concentrate
REF: LC+200-D,LC+201, LC+225(45X) Open, Classified |
KPO | K223431 |
| Sep 10, 2026 | Nipro Renal Soultions USA, Corporation Citric Complete Dry Citric Acid Concentrate
REF: DCA+200-25 & DCA+203-25 Open, Classified |
KPO | K171750 |
| Sep 10, 2026 | Nipro Renal Soultions USA, Corporation MedicaLyte Bicarbonate Powder
REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X)) Open, Classified |
KPO | K131202 |
| Sep 10, 2026 | Nipro Renal Soultions USA, Corporation MedicaLyte Liquid Bicarbonate Concentrate
REF: BC-100 and BC+201 Open, Classified |
KPO | K012547 |
| Sep 9, 2026 | Medical Action Industries, Inc. 306 Kit: Single Shot Epidural 20/Cs, REF: 59553;
Kit: Single Shot Epidural 20/Cs, REF: 83945B.
Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules Open, Classified |
OFT | None listed |
| Sep 9, 2026 | Medical Action Industries, Inc. 306 Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules Open, Classified |
OGJ | None listed |
| Sep 4, 2026 | Atrium Medical Corporation Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case;
Size(Model Number): 1. 28FR(15028), 2. 36FR(15036); Open, Classified |
GBZ | None listed |
| Sep 4, 2026 | Atrium Medical Corporation Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case;
Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136); Open, Classified |
GBZ | None listed |
| Sep 4, 2026 | Atrium Medical Corporation Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case;
Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036); Open, Classified |
GBZ | None listed |
| Sep 4, 2026 | Lutronic Corporation Product Name: DermaV Laser System
Model/Catalog Number: DermaV
Medical laser device that delivers pulsed laser energy at wavelengths of 532 nm and 1064 nm through a fiber-optic handpiece. The system Open, Classified |
GEX | K203788 |
| Sep 4, 2026 | HeartSine Technologies Ltd HeartSine SAM 350P
350P US Device, US English - 2 Min CPR
UDI-DI codes:
0506016712067
350P US Device, US English (American Airlines) - 2 Min CPR
UDI-DI code:
0506016712207
350P US Device, US English Open, Classified |
MKJ | None listed |
| Sep 4, 2026 | AVID Medical, Inc. Halyard IV Start Kit Non-Sterile
REF: KRIV26-02 Open, Classified |
LRO | None listed |
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
(Canada Only)
SureStep" Foley Tray System Bardex IC Complete Care
REF: A300314AC
UDI-DI code: 00801741143243
SureStep" Foley Tray System Bardex IC Complete C Open, Classified |
KNX | None listed |
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
SureStep" Foley Tray System Add-A-Foley Catheter
REF: A153200
UDI code: 00801741121067 10801741121064
SureStep" Foley Tray System Complete Care Add-A-Foley Open, Classified |
KNX | None listed |
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
SureStep Intermittent Catheter Tray
REF:
INTP16
INTS14
INTS14C
INTS16
INTS16C
PEDINTS06
PEDINTS08
PEDINTS10
UDI code:
00801741183300 10801741183307
008017411 Open, Classified |
KOD | K000723 K802665 |
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
*Bardex I.C. Complete Care Foley Catheter Tray
REF: 300316A
UDI codes: 00801741024344 10801741024341
*Bardex I.C. Complete Care Foley Catheter Tray and Urin Open, Classified |
MJC | K040658 K910318 +1 |
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
Bard Foley Tray With Lubri-Sil All-Silicone Foley Catheter
REF:
947314
947316
947318
UDI codes:
00801741024924 10801741024921
00801741024931 10801741024938
0 Open, Classified |
EZL | K040504 K070508 +2 |
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
Bardex Lubricath Foley Catheter Tray
REF:
899914
899916
899918
UDI codes:
00801741024801 10801741024808
00801741024818 10801741024815
00801741024825 10801741 Open, Classified |
EZC | K910197 K910846 |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, CHONY ORTHO MAJOR SPINE , Catalog Number: POV2SCCPP;
2) KIT,ORTHOPLASTIC MICROVASCULAR, Catalog Number: Open, Classified |
OJH | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, ASLMC CRANIOTOMY , Catalog Number: PNCGCNAUM;
2) KIT, ORP MAJOR SPINE , Catalog Number: Open, Classified |
OJG | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) PBCGLVBLI, Catalog Number: KIT, BLO LAVH ;
2) PB15HYFCY, Catalog Number: KIT, UMMC AB HYST II Open, Classified |
OJF | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM3;
2) KIT, ROBOTIC HYST , Catalog Number: Open, Classified |
OHM | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, BLO ROBOTIC GYN , Catalog Number: PBCGRGB28;
2) KIT , GYN MAJOR BARNES JEWIS, Catalog Number: Open, Classified |
OHD | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, ENT HARVEST , Catalog Number: PEVMETBJX;
2) KIT, ENT HARVEST , Catalog Number: Open, Classified |
OGR | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number: PWV2MF01D Open, Classified |
OFX | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG540;
2) KIT, GVI OPEN HEART A B , Catalog Number: Open, Classified |
OEZ | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT,ROBOTICS DH , Catalog Number: PGOCRDNHD;
2) KIT, EAS ROBOTIC , Catalog Number: Open, Classified |
NWU | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, LUNG TX CIRCULATOR , Catalog Number: OVC3507231 Open, Classified |
LRP | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, GYN ROBOTIC GSAM , Catalog Number: PBCCGRSGD;
2) KIT, GYN ROBOT ACCESSORY , Catalog Number: Open, Classified |
LRO | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT,GYN LAPAROSCOPY DH , Catalog Number: PBOCGLN17 Open, Classified |
FDE | None listed |
| Sep 3, 2026 | Fresenius Medical Care Renal Therapies Group, LLC Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis Open, Classified |
KPO | K192017 K212620 |
| Sep 3, 2026 | Fresenius Medical Care Renal Therapies Group, LLC NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for Open, Classified |
KPO | K192017 K212620 |