FDA Device · 2024
FDA Device recalls in 2024
RecallRadar indexes 3,393 FDA Device recall notices published in 2024. By classification: 392 Class I, 2,970 Class II, 31 Class III.
- EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients wh…
FDA Device · Class II · 2024-04-17 · Boston Scientific - Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 01-03-0044 01-03-004…
FDA Device · Class II · 2024-04-17 · Synovo Production - EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult pa…
FDA Device · Class II · 2024-04-17 · Boston Scientific - EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult pat…
FDA Device · Class II · 2024-04-17 · Boston Scientific - Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), b) Medline SwivAssist Bar, Model Numb…
FDA Device · Class II · 2024-04-17 · Medline Industries Northfield - ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01-02-4760 01-02-4962…
FDA Device · Class II · 2024-04-17 · Synovo Production - Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
FDA Device · Class II · 2024-04-17 · Intuitive Surgical - EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult p…
FDA Device · Class II · 2024-04-17 · Boston Scientific - Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M,C7, 714682
FDA Device · Class II · 2024-04-17 · Baxter Healthcare - Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE,PLUG2/EUR, VS100-2
FDA Device · Class II · 2024-04-17 · Baxter Healthcare - 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
FDA Device · Class II · 2024-04-17 · Human Care Hc Sweden Ab - Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS6800BAMMS
FDA Device · Class II · 2024-04-17 · Medline Industries Northfield - EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients…
FDA Device · Class II · 2024-04-17 · Boston Scientific - ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile
FDA Device · Class II · 2024-04-17 · Convatec - PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-…
FDA Device · Class II · 2024-04-17 · Philips North America - KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
FDA Device · Class II · 2024-04-17 · Microbiologics - ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0554 01-01-0556 01-0…
FDA Device · Class II · 2024-04-17 · Synovo Production - RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs
FDA Device · Class II · 2024-04-17 · Raysearch Laboratories Ab - Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP, BLUETOOTH,…
FDA Device · Class II · 2024-04-17 · Baxter Healthcare - LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0
FDA Device · Class I · 2024-04-17 · Fresenius Kabi Usa - EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biol…
FDA Device · Class II · 2024-04-17 · Qiagen Sciences - Hemostasis Probe, Model: CD-B622LA
FDA Device · Class II · 2024-04-17 · Olympus - Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Num…
FDA Device · Class II · 2024-04-10 · Exactech - Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
FDA Device · Class II · 2024-04-10 · Karl Storz Endoscopy - Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL
FDA Device · Class II · 2024-04-10 · Covidien - Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of p…
FDA Device · Class II · 2024-04-10 · Baxter Healthcare - Alinity i Anti-HCV Reagent Kit, List Number 08P0521
FDA Device · Class II · 2024-04-10 · Abbott - Mojo 2 Full Face AAV Non Vented Mask, All Sizes
FDA Device · Class I · 2024-04-10 · Sleepnet - Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
FDA Device · Class II · 2024-04-10 · Covidien - Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head…
FDA Device · Class II · 2024-04-10 · Exactech - Mojo Non Vented Full Face Mask with Headgear, All Sizes
FDA Device · Class I · 2024-04-10 · Sleepnet - Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Centurion STERILE BLOOD COLLECTION TUBE,10ML, Product Code 6430ST
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only
FDA Device · Class II · 2024-04-10 · Karl Storz Endoscopy - Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code 66520
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium,…
FDA Device · Class II · 2024-04-10 · Exactech - BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) contai…
FDA Device · Class II · 2024-04-10 · Becton Dickinson And - Centurion STERILE #16 RUBBER BAND, Product Code EB16
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20
FDA Device · Class II · 2024-04-10 · Abbott Laboratories - Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of huma…
FDA Device · Class II · 2024-04-10 · Life Technologies - MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
FDA Device · Class II · 2024-04-10 · Navinetics - ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
FDA Device · Class II · 2024-04-10 · Abbott - Centurion PICC LINE SECUREMENT KIT, Product Code IVS565
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - X-Guide Handpiece Adaptor Sleeve 1, Model P010701
FDA Device · Class II · 2024-04-10 · X Nav Technologies - MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41,…
FDA Device · Class II · 2024-04-10 · Exactech - Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
FDA Device · Class II · 2024-04-10 · Covidien - Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Should…
FDA Device · Class II · 2024-04-10 · Exactech - Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13
FDA Device · Class II · 2024-04-10 · Exactech - Mojo 2 Full Face Vented Mask, All Sizes
FDA Device · Class I · 2024-04-10 · Sleepnet - Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03
FDA Device · Class II · 2024-04-10 · Exactech - Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03
FDA Device · Class II · 2024-04-10 · Exactech - Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13
FDA Device · Class II · 2024-04-10 · Exactech - Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
FDA Device · Class II · 2024-04-10 · Covidien - Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03
FDA Device · Class II · 2024-04-10 · Exactech - Centurion STERILE TRACH BRUSH, Product Code 6225ST
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22,…
FDA Device · Class II · 2024-04-10 · Exactech - ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System
FDA Device · Class II · 2024-04-10 · Depuy Orthopaedics - Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41,…
FDA Device · Class II · 2024-04-10 · Exactech - Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
FDA Device · Class II · 2024-04-10 · Karl Storz Endoscopy - Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Ureteral dilator, REF RBD014
FDA Device · Class II · 2024-04-10 · Coloplast Manufacturing Us - Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) contai…
FDA Device · Class II · 2024-04-10 · Becton Dickinson And - Agfa DX-D 100 system-Digital Radiography mobile X-ray System
FDA Device · Class II · 2024-04-10 · Agfa N V - Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Numb…
FDA Device · Class II · 2024-04-10 · Exactech - Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13
FDA Device · Class II · 2024-04-10 · Exactech - Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head…
FDA Device · Class II · 2024-04-10 · Exactech - Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - iQ 2 Nasal Vented Mask
FDA Device · Class I · 2024-04-10 · Sleepnet - X-Guide Handpiece Adaptor Sleeve 3, Model P010727
FDA Device · Class II · 2024-04-10 · X Nav Technologies - Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number…
FDA Device · Class II · 2024-04-10 · Exactech - Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
FDA Device · Class II · 2024-04-10 · Covidien - Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02
FDA Device · Class II · 2024-04-10 · Exactech - HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
FDA Device · Class III · 2024-04-10 · O And M Halyard - 3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile
FDA Device · Class II · 2024-04-10 · 3m Health Care Business - Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
FDA Device · Class II · 2024-04-10 · Covidien - Mojo 2 Full Face Non Vented Mask, All Sizes
FDA Device · Class I · 2024-04-10 · Sleepnet - Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66…
FDA Device · Class II · 2024-04-10 · Terumo Cardiovascular Systems - Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
FDA Device · Class II · 2024-04-10 · Covidien - Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03
FDA Device · Class II · 2024-04-10 · Exactech - Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
FDA Device · Class II · 2024-04-10 · Covidien - Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03
FDA Device · Class II · 2024-04-10 · Exactech - Mojo Full Face with Headgear, All Sizes
FDA Device · Class I · 2024-04-10 · Sleepnet - Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield
Other years
2026 (2,088) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)