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-2793-2017 | Class II | SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx... | LivaNova USA, Inc. | DWE | |
| Z-2792-2017 | Class II | SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx... | LivaNova USA, Inc. | DWE | |
| Z-2791-2017 | Class II | STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703... | LivaNova USA, Inc. | DWE | |
| Z-2790-2017 | Class II | SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx... | LivaNova USA, Inc. | DWE | |
| Z-2789-2017 | Class II | SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx... | LivaNova USA, Inc. | DWE | |
| Z-2788-2017 | Class II | SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF... | LivaNova USA, Inc. | DWE | |
| Z-2787-2017 | Class II | SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx... | LivaNova USA, Inc. | DWE | |
| Z-2786-2017 | Class II | SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA | LivaNova USA, Inc. | DWE | |
| Z-2785-2017 | Class II | SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx... | LivaNova USA, Inc. | DWE | |
| Z-2784-2017 | Class II | SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE... | LivaNova USA, Inc. | DWE | |
| Z-2783-2017 | Class II | SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA | LivaNova USA, Inc. | DWE | |
| Z-3039-2017 | Class II | SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide... | Boston Scientific Corporation | LWS | |
| Z-3038-2017 | Class II | EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx... | Boston Scientific Corporation | LWS | |
| Z-3037-2017 | Class II | EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX... | Boston Scientific Corporation | LWS | |
| Z-3058-2017 | Class II | Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908... | Medtronic Navigation, Inc | PGW | |
| Z-3057-2017 | Class II | Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains... | Medtronic Navigation, Inc | PGW | |
| Z-3056-2017 | Class II | Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452... | Medtronic Navigation, Inc | PGW | |
| Z-3055-2017 | Class II | Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit... | Medtronic Navigation, Inc | PGW | |
| Z-3054-2017 | Class II | Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is... | Medtronic Navigation, Inc | PGW | |
| Z-3053-2017 | Class II | Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is... | Medtronic Navigation, Inc | PGW | |
| Z-3052-2017 | Class II | Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on the label is... | Medtronic Navigation, Inc | PGW | |
| Z-3051-2017 | Class II | Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is... | Medtronic Navigation, Inc | PGW | |
| Z-2777-2017 | Class II | GE Inspection Technologies Blade|line Industrial Cabinet X-ray system | GE Inspection Technologies, LP | RCE | |
| Z-0546-2018 | Class II | Safety Deluxe Bone Marrow Biopsy/Aspiration Tray, Catalog # 986 Product Usage: Surgical... | Busse Hospital Disposables | PWY | |
| Z-0545-2018 | Class II | Lumbar Puncture Tray, Catalog # 1862 Product Usage: Surgical procedure | Busse Hospital Disposables | PWY | |
| Z-0544-2018 | Class II | Laceration Tray, Catalog # 1892R1 Product Usage: Surgical procedure | Busse Hospital Disposables | PWY | |
| Z-0543-2018 | Class II | Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspiration... | Busse Hospital Disposables | PWY | |
| Z-0542-2018 | Class II | Safety-Deluxe Lumbar Puncture Tray, Catalog # 975 Product Usage: Surgical procedure | Busse Hospital Disposables | PWY | |
| Z-0541-2018 | Class II | Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977 Product... | Busse Hospital Disposables | PWY | |
| Z-0540-2018 | Class II | Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical procedure | Busse Hospital Disposables | PWY | |
| Z-0257-2018 | Class II | Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and... | Terumo Cardiovascular Systems Corporation | DTL | |
| Z-0256-2018 | Class II | TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J | Terumo Cardiovascular Systems Corporation | DTL | |
| Z-3236-2017 | Class II | NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000... | Novadaq Technologies ULC | MMP | |
| Z-3235-2017 | Class II | NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006... | Novadaq Technologies ULC | MMP | |
| Z-3234-2017 | Class II | NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape), Sterile... | Novadaq Technologies ULC | MMP | |
| Z-2864-2017 | Class II | Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample... | Hologic, Inc. | JQW | |
| Z-2758-2017 | Class II | Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Cardinal... | Medtronic, Inc. | KKX | |
| Z-2757-2017 | Class II | Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty... | Medtronic, Inc. | KKX | |
| Z-0067-2018 | Class II | Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only... | Encore Medical, LP | LOD | |
| Z-0066-2018 | Class II | Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERILE, Rx Only... | Encore Medical, LP | LOD | |
| Z-3114-2017 | Class II | Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is... | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-3113-2017 | Class II | Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are... | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-0065-2018 | Class II | Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET... | Encore Medical, LP | LOD | |
| Z-0064-2018 | Class II | Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET... | Encore Medical, LP | LOD | |
| Z-3084-2017 | Class III | Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26... | Ameditech, Inc. | LFH | |
| Z-2802-2017 | Class II | Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst 060x132CM - US... | Stryker Corp. | NRY | |
| Z-2801-2017 | Class II | Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microcatheter, AXS... | Stryker Corp. | NRY | |
| Z-2800-2017 | Class II | Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microcatheter, AXS... | Stryker Corp. | NRY | |
| Z-2799-2017 | Class II | Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcatheter, AXS... | Stryker Corp. | NRY | |
| Z-3078-2017 | Class II | Burn Sheet, sterile - 60" x 96". Included in First Aid Kits: 36M - Delmarva Power/ACE... | Certified Safety Mfg Inc | OJJ |