Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Pacific Lasertech, Llc
N-LHP-928, HeNe Laser System, 35 mW
Medical Devices·32 affected·Mar 1, 2024
CriticalFDA
Sleepnet Corporation
iQ 2 Nasal Vented Mask
Medical Devices·2,477 affected·Mar 1, 2024
CriticalFDA
Sleepnet Corporation
Mojo 2 Full Face Non Vented Mask, All Sizes
Medical Devices·2,107 affected·Mar 1, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PUDENDAL KIT, REF D...
Medical Devices·12,994 affected·Mar 1, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience tray
Medical Devices·30 affected·Mar 1, 2024
CriticalFDA
Sleepnet Corporation
Mojo Non Vented Full Face Mask with Headgear, All Sizes
Medical Devices·11,874 affected·Mar 1, 2024
High RiskFDA
Pacific Lasertech, Llc
25-LHP-828, HeNe Laser System, 35 mW
Medical Devices·4 affected·Mar 1, 2024
High RiskFDA
Covidien, Lp
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
Medical Devices·165,356 affected·Feb 28, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO
Medical Devices·9,549 affected·Feb 28, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225
Medical Devices·2,413 affected·Feb 28, 2024
High RiskFDA
Covidien, Lp
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
Medical Devices·93,673 affected·Feb 28, 2024
High RiskFDA
Covidien, Lp
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
Medical Devices·11,796 affected·Feb 28, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIO
Medical Devices·9,899 affected·Feb 28, 2024
High RiskFDA
Philips North America
CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
Medical Devices·2,323 affected·Feb 28, 2024
High RiskFDA
Philips North America
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Versi...
Medical Devices·257,183 affected·Feb 28, 2024
High RiskFDA
Covidien, Lp
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL
Medical Devices·44,777 affected·Feb 28, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016
Medical Devices·4,774 affected·Feb 28, 2024
High RiskFDA
Karl Storz Endoscopy
Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
Medical Devices·27 affected·Feb 27, 2024
CriticalFDA
Smiths Medical Asd Inc.
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arteri...
Medical Devices·0 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-1...
Medical Devices·0 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D
Medical Devices·0 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66H
Medical Devices·0 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D
Medical Devices·45 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E
Medical Devices·3 affected·Feb 27, 2024
High RiskFDA
Convatec, Inc
ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package,...
Medical Devices·63 affected·Feb 27, 2024
High RiskFDA
Karl Storz Endoscopy
Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only
Medical Devices·147 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-64H
Medical Devices·0 affected·Feb 27, 2024
High RiskFDA
Ortho-clinical Diagnostics
VITROS Performance Verifier I
Medical Devices·10,911 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D
Medical Devices·0 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52E
Medical Devices·48 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F
Medical Devices·0 affected·Feb 27, 2024
High RiskFDA
Emergency Products & Research
O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
Medical Devices·190,000 affected·Feb 27, 2024
CriticalFDA
Medline Industries, Lp - Northfield
Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF DYNJ18865, Polyur...
Medical Devices·168,632 affected·Feb 26, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335
Medical Devices·1,350 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6
Medical Devices·100 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), P...
Medical Devices·80,903 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724
Medical Devices·2,458 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A
Medical Devices·4,200 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion STERILE #16 RUBBER BAND, Product Code EB16
Medical Devices·150 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNELL RETRACTOR (RR60...
Medical Devices·760 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code 66520; b) STERILE TOWEL CLAMP, Product Code A...
Medical Devices·12,980 affected·Feb 23, 2024
High RiskFDA
Agfa N.v.
Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digi...
Medical Devices·541 affected·Feb 23, 2024
High RiskFDA
Human Care Hc Sweden Ab
Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts
Medical Devices·10 affected·Feb 23, 2024
High RiskFDA
Carefusion 303, Inc.
BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Medical Devices·0 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723
Medical Devices·0 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKIN HOOK (25754), P...
Medical Devices·1,520 affected·Feb 23, 2024
High RiskFDA
Bruder Healthcare Company, Llc
Thermalon Stye Compress, Item Number 24352
Medical Devices·24 affected·Feb 21, 2024
High RiskFDA
Bruder Healthcare Company, Llc
Thermalon Sinus Compress (French), Item Number 24332F
Medical Devices·2,160 affected·Feb 21, 2024