Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-1208-2023 | Class II | SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material... | Coltene /Whaledent AG | EFB | |
| Z-0007-2025 | Class II | IntelliVue G7m Anesthesia Gas Module, Product Number 866173 | Philips North America LLC | DSI | |
| Z-1211-2023 | Class II | Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1. | LINET spol. s r.o. | FPO | |
| Z-1314-2023 | Class II | Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305 | FUJIFILM Biosciences Inc. | MQL | |
| Z-1136-2023 | Class II | SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-1135-2023 | Class II | SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-1134-2023 | Class II | SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-1144-2023 | Class II | Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D... | Hologic, Inc. | OTE | |
| Z-1171-2023 | Class II | Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile. | Summit Medical, LLC | LFB | |
| Z-1183-2023 | Class II | Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8... | Medtronic, Inc. | FTL | |
| Z-1154-2023 | Class II | ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative... | Siemens Healthcare Diagnostics Inc. | JJX | |
| Z-1153-2023 | Class II | ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative... | Siemens Healthcare Diagnostics Inc. | JJX | |
| Z-1152-2023 | Class II | ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative... | Siemens Healthcare Diagnostics Inc. | JJX | |
| Z-1151-2023 | Class II | Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative... | Siemens Healthcare Diagnostics Inc. | CGN | |
| Z-1150-2023 | Class II | Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative... | Siemens Healthcare Diagnostics Inc. | CGN | |
| Z-1149-2023 | Class II | Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative... | Siemens Healthcare Diagnostics Inc. | CGN | |
| Z-1160-2023 | Class III | abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm... | S & Mohr America, S.A. de C.V. | CAH | |
| Z-1102-2023 | Class II | WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation... | Wishbone Medical, Inc. | KTT | |
| Z-1051-2023 | Class II | Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610... | Bard Peripheral Vascular Inc | LJS | |
| Z-1376-2023 | Class II | Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840... | Western Enterprises, Inc. | CAN | |
| Z-1059-2023 | Class III | FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange... | Owens & Minor Distribution, Inc. | FXX | |
| Z-1043-2023 | Class II | (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint... | Zimmer GmbH | JWH | |
| Z-1042-2023 | Class II | (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint... | Zimmer GmbH | JWH | |
| Z-1163-2023 | Class II | (1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chloraprep... | MEDLINE INDUSTRIES, LP - Northfield | OJH | |
| Z-1162-2023 | Class II | (1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case, contains... | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-1161-2023 | Class II | Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case... | MEDLINE INDUSTRIES, LP - Northfield | FCH | |
| Z-1014-2023 | Class II | MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens... | CooperVision, Inc. | LPL | |
| Z-0640-2024 | Class II | Incisive CT, model 728143 & 728144 running Software Version 5.0.0. | Philips Healthcare (Suzhou) Co., Ltd. | JAK | |
| Z-2067-2023 | Class II | LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left... | Waldemar Link GmbH & Co. KG | JWH | |
| Z-2066-2023 | Class II | LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left... | Waldemar Link GmbH & Co. KG | JWH | |
| Z-1015-2023 | Class II | Centurion Medical Products, Silver Antimicrobial Vad Drive, Ref Dt18760 | MEDLINE INDUSTRIES, LP - Northfield | OXQ | |
| Z-1100-2023 | Class II | Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with... | Quest Medical, Inc | FPA | |
| Z-1143-2023 | Class II | ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic... | Siemens Healthcare Diagnostics Inc. | LOM | |
| Z-1156-2023 | Class II | HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days)... | Access Vascular, Inc | FOZ | |
| Z-1155-2023 | Class II | HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access... | Access Vascular, Inc | FOZ | |
| Z-1187-2023 | Class II | Empowr Vvc Knee Tibial Insert, Size 6, 22Mm, Ref: 346-22-706; Empowr Vvc Knee Tibial... | Encore Medical, LP | JWH | |
| Z-1047-2023 | Class II | MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013 | MEDLINE INDUSTRIES, LP - Northfield | KRR | |
| Z-1046-2023 | Class II | MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008 | MEDLINE INDUSTRIES, LP - Northfield | KRR | |
| Z-1045-2023 | Class II | MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008 | MEDLINE INDUSTRIES, LP - Northfield | KRR | |
| Z-1003-2023 | Class II | Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1101-2023 | Class II | RipCord Syndesmosis Button, REF: STA001K | Trimed Inc | HTN | |
| Z-1020-2023 | Class II | AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF... | Salter Labs | CAE | |
| Z-1019-2023 | Class II | Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0... | Salter Labs | CAE | |
| Z-0996-2023 | Class II | Vasoshield Syringe Packs, Model VH-5001 | Maquet Cardiovascular LLC | GBX | |
| Z-0995-2023 | Class II | Hemopro 2 with Vasoshield, Model VH-4001 | Maquet Cardiovascular LLC | GEI | |
| Z-1108-2023 | Class II | The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised... | Bard Peripheral Vascular Inc | PFV | |
| Z-0961-2023 | Class I | Getinge Flow-e Anesthesia System, Part No. 6887900 | Maquet Cardiovascular Us Sales, LLC | BSZ | |
| Z-0960-2023 | Class I | Getinge Flow-c Anesthesia System, Part No. 6887700 | Maquet Cardiovascular Us Sales, LLC | BSZ | |
| Z-0959-2023 | Class I | Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no... | Maquet Cardiovascular Us Sales, LLC | BSZ | |
| Z-1168-2023 | Class II | Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic... | Siemens Medical Solutions USA, Inc. | OWB |