Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Olympus Corporation Of The Americas
Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B
Medical Devices·45 affected·May 4, 2023
High RiskFDA
Olympus Corporation Of The Americas
Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A
Medical Devices·13,707 affected·May 4, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
Medical Devices·851,328 affected·May 3, 2023
CriticalFDA
Noxbox Ltd
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
Medical Devices·548 affected·May 3, 2023
High RiskFDA
Smith & Nephew, Inc.
Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-20...
Medical Devices·1,596 affected·May 2, 2023
High RiskFDA
Smith & Nephew, Inc.
Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZE 1 Right Medial)...
Medical Devices·1,994 affected·May 2, 2023
High RiskFDA
Smith & Nephew, Inc.
Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL; b) REF 1...
Medical Devices·2,146 affected·May 2, 2023
High RiskFDA
Implant Direct Sybron Manufacturing Llc
LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 87...
Medical Devices·29 affected·May 2, 2023
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB220...
Medical Devices·18,855 affected·May 1, 2023
High RiskFDA
Becton Dickinson & Co.
BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, simultaneous quali...
Medical Devices·70,948 affected·May 1, 2023
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B,...
Medical Devices·57,395 affected·May 1, 2023
High RiskFDA
Nrt X-ray A/s
Intelli-C, Left side suspended Tabletop, REF: 03400010
Medical Devices·13 affected·Apr 27, 2023
High RiskFDA
Nrt X-ray A/s
Intelli-C, Right side suspended Tabletop, REF: 03400000
Medical Devices·32 affected·Apr 27, 2023
High RiskFDA
Linkbio Corp.
LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revisio...
Medical Devices·11 affected·Apr 25, 2023
High RiskFDA
Davol, Inc.
Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning sy...
Medical Devices·169 affected·Apr 25, 2023
CriticalFDA
Biofire Diagnostics, Llc
FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
Medical Devices·61,069 affected·Apr 25, 2023
High RiskFDA
Lumiradx
SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566...
Medical Devices·1,003 affected·Apr 25, 2023
High RiskFDA
Davol, Inc.
Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning sy...
Medical Devices·0 affected·Apr 25, 2023
High RiskFDA
Philips North America
Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
Medical Devices·20 affected·Apr 25, 2023
High RiskFDA
Avanos Medical, Inc.
AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
Medical Devices·33 affected·Apr 24, 2023
High RiskFDA
Avanos Medical, Inc.
SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
Medical Devices·45 affected·Apr 24, 2023
High RiskFDA
Windstone Medical Packaging, Inc.
Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Medical Devices·60 affected·Apr 24, 2023
High RiskFDA
Avanos Medical, Inc.
ambIT Cassette Filter Male Luer, Product Code: 220266
Medical Devices·1,155 affected·Apr 24, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) ...
Medical Devices·342 affected·Apr 21, 2023
High RiskFDA
Masimo Corporation
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
Medical Devices·123,745 affected·Apr 21, 2023
High RiskFDA
Masimo Corporation
Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
Medical Devices·138,926 affected·Apr 21, 2023
High RiskFDA
Masimo Corporation
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
Medical Devices·443,799 affected·Apr 21, 2023
High RiskFDA
Philips North America
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
Medical Devices·591 affected·Apr 19, 2023
CriticalFDA
Draeger Medical, Inc.
VentStar Basic (P)180, MP00351
Medical Devices·325 affected·Apr 17, 2023
CriticalFDA
Draeger Medical, Inc.
Seattle PAP Plus, MP02260
Medical Devices·32,050 affected·Apr 17, 2023
CriticalFDA
Draeger Medical, Inc.
VentStar Anesthesia WT (P)180, MP00374
Medical Devices·130 affected·Apr 17, 2023
CriticalFDA
Draeger Medical, Inc.
Anesthesia Set Coax 180, MP03384
Medical Devices·20 affected·Apr 17, 2023
CriticalFDA
Draeger Medical, Inc.
VentStar Watertrap (N) 180, MP00363
Medical Devices·125 affected·Apr 17, 2023
CriticalFDA
Draeger Medical, Inc.
VentStar Watertrap (P) 180, MP00361
Medical Devices·50 affected·Apr 17, 2023
CriticalFDA
Draeger Medical, Inc.
VentStar Anesthesia (N) 180, MP00333
Medical Devices·0 affected·Apr 17, 2023
CriticalFDA
Draeger Medical, Inc.
Ventstar Coax, MP03373
Medical Devices·2,380 affected·Apr 17, 2023
CriticalFDA
Draeger Medical, Inc.
ID Circuit Basic (P) 180, MP01340
Medical Devices·25 affected·Apr 17, 2023
CriticalFDA
Draeger Medical, Inc.
VentStar Basic (P)250, MP00352
Medical Devices·200 affected·Apr 17, 2023
CriticalFDA
Draeger Medical, Inc.
Anesthesia Circuit Kit Coax 3, MP02732
Medical Devices·329,294 affected·Apr 17, 2023
CriticalFDA
Draeger Medical, Inc.
Ventstar Coax 180, MP03374
Medical Devices·18,160 affected·Apr 17, 2023
CriticalFDA
Draeger Medical, Inc.
Anesthesia Circuit Kit Coax 1, MP02730
Medical Devices·200,900 affected·Apr 17, 2023
High RiskFDA
Stryker Sustainability Solutions
REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
Medical Devices·50 affected·Apr 14, 2023
High RiskFDA
Howmedica Osteonics Corp.
TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E
Medical Devices·24 affected·Apr 13, 2023
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative imm...
Medical Devices·540 affected·Apr 13, 2023
High RiskFDA
Howmedica Osteonics Corp.
TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
Medical Devices·24 affected·Apr 13, 2023
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobiliz...
Medical Devices·2,372 affected·Apr 13, 2023
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobili...
Medical Devices·3,328 affected·Apr 13, 2023
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative im...
Medical Devices·805 affected·Apr 13, 2023