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-1109-2021 | Class II | BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482 | Becton Dickinson & Co | FMF | |
| Z-0882-2021 | Class II | A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product... | Zimmer GmbH | HRS | |
| Z-1114-2021 | Class I | Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit... | Safeguard US Operating LLC | POQ | |
| Z-1113-2021 | Class I | Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience... | Safeguard US Operating LLC | POQ | |
| Z-1112-2021 | Class I | Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience... | Safeguard US Operating LLC | POQ | |
| Z-1111-2021 | Class I | Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit... | Safeguard US Operating LLC | POQ | |
| Z-1110-2021 | Class I | Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience... | Safeguard US Operating LLC | POQ | |
| Z-1415-2021 | Class II | The EOSedge system may acquire two simultaneous orthogonal planar images for a standing... | EOS imaging | KPR | |
| Z-0932-2021 | Class III | Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C... | FUJIFILM Healthcare Americas Corporation | JIS | |
| Z-1099-2021 | Class II | Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe... | Cytocell Limited | MVU | |
| Z-0881-2021 | Class II | Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium... | Abbott Medical | CHL | |
| Z-0880-2021 | Class II | Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium... | Abbott Medical | CHL | |
| Z-1124-2021 | Class II | Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer... | Getinge Group Logistics America, LLC | MEC | |
| Z-0919-2021 | Class II | Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698... | Hardy Diagnostics | JSO | |
| Z-0922-2021 | Class II | SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the... | Omni Life Science, Inc. | LZO | |
| Z-0921-2021 | Class II | SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the... | Omni Life Science, Inc. | LZO | |
| Z-0920-2021 | Class II | SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the... | Omni Life Science, Inc. | LZO | |
| Z-1102-2021 | Class II | Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV... | Baxter Healthcare Corporation | FPA | |
| Z-0874-2021 | Class II | Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that... | Abbott Medical | BWF | |
| Z-0865-2021 | Class II | PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS... | Nihon Kohden America Inc | GWQ | |
| Z-1144-2021 | Class II | ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0952-2021 | Class II | Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage... | Topcon Healthcare, Inc. | NFJ | |
| Z-0842-2021 | Class II | AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X... | Ansh Labs, LLC | QKO | |
| Z-0925-2021 | Class I | Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the... | Hill-Rom Inc. | FSA | |
| Z-0938-2021 | Class II | ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323... | Alung Technologies, Inc. | QLN | |
| Z-0933-2021 | Class II | VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number... | Smith & Nephew, Inc. | LOD | |
| Z-0868-2021 | Class II | Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052... | Laerdal Medical (Suzhou) Co., Ltd. | JCX | |
| Z-1130-2021 | Class II | System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES. | GE Healthcare | JAK | |
| Z-1129-2021 | Class II | System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition | GE Healthcare | JAK | |
| Z-0883-2021 | Class II | A calculator/data processing module for clinical use is an electronic device intended to... | Roche Diagnostics GmbH | JQP | |
| Z-0942-2021 | Class II | Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0810-2021 | Class II | EXOGEN Ultrasound Coupling Gel | Bioventus LLC | LOF | |
| Z-0546-2022 | Class III | KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component... | Microbiologics, Inc. | JTR | |
| Z-0511-2022 | Class II | KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK... | Microbiologics, Inc. | JTR | |
| Z-0873-2021 | Class II | REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344... | Medtronic Neurosurgery | JXG | |
| Z-0872-2021 | Class II | REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344... | Medtronic Neurosurgery | JXG | |
| Z-0871-2021 | Class II | REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344... | Medtronic Neurosurgery | JXG | |
| Z-0944-2021 | Class II | Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C... | Philips North America LLC | IYN | |
| Z-0809-2021 | Class II | Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707 | Cook Medical LLC | MQG | |
| Z-1084-2021 | Class II | WAHL 4212 HEATED MASSAGER, SKU F800000004212 - Product Usage: intended to relieve minor... | Wahl Clipper Corp | ISA | |
| Z-0851-2021 | Class I | Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow... | Penumbra Inc. | NRY | |
| Z-0850-2021 | Class I | Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF... | Penumbra Inc. | NRY | |
| Z-0849-2021 | Class I | Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF... | Penumbra Inc. | NRY | |
| Z-0870-2021 | Class II | ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide... | Boston Scientific Corporation | DQY | |
| Z-0845-2021 | Class II | VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively... | Ortho-Clinical Diagnostics, Inc. | CEK | |
| Z-0844-2021 | Class II | VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in... | Ortho-Clinical Diagnostics, Inc. | CEK | |
| Z-0848-2021 | Class I | Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter... | Penumbra Inc. | NRY | |
| Z-0726-2021 | Class II | PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45 | Abbott Medical | JOH | |
| Z-0802-2021 | Class II | Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058... | Depuy Orthopaedics Inc. | KWA | |
| Z-1899-2021 | Class II | VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F... | Bard Peripheral Vascular Inc | QAN |