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-0965-2023 | Class I | CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF... | Abbott Medical | FPA | |
| Z-0964-2023 | Class I | CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF... | Abbott Medical | FPA | |
| Z-0963-2023 | Class I | CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF... | Abbott Medical | FPA | |
| Z-0962-2023 | Class I | CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24 | Abbott Medical | FPA | |
| Z-1002-2023 | Class II | Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1001-2023 | Class II | AXIOM Luminos Agile | Siemens Medical Solutions USA, Inc. | JAA | |
| Z-1000-2023 | Class II | AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1009-2023 | Class II | Alinity m System. The Alinity m System is designed to automate the steps for nucleic... | Abbott Molecular, Inc. | OOI | |
| Z-0953-2023 | Class II | RadiaLux Lighted Retractor (Pink), REF: 50-101-1 | Medtronic Navigation, Inc | GAD | |
| Z-1012-2023 | Class II | Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High... | Teleflex Medical | BTR | |
| Z-1011-2023 | Class II | Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and... | Teleflex Medical | BTR | |
| Z-1010-2023 | Class II | Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients... | Teleflex Medical | BTR | |
| Z-0879-2023 | Class II | Detect Covid-19 Test Product/Model Number: 21205 | Detect Headquarters | QKP | |
| Z-1128-2023 | Class II | Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850... | MEDLINE INDUSTRIES, LP - Northfield | OJH | |
| Z-1127-2023 | Class II | Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS CIRCUMCISION TRAY... | MEDLINE INDUSTRIES, LP - Northfield | OHG | |
| Z-1126-2023 | Class II | Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAY... | MEDLINE INDUSTRIES, LP - Northfield | KYZ | |
| Z-1125-2023 | Class II | Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number... | MEDLINE INDUSTRIES, LP - Northfield | KKX | |
| Z-1124-2023 | Class II | Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE... | MEDLINE INDUSTRIES, LP - Northfield | OXQ | |
| Z-1123-2023 | Class II | Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYNDL1643A | MEDLINE INDUSTRIES, LP - Northfield | OJU | |
| Z-1122-2023 | Class II | Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reorder Number... | MEDLINE INDUSTRIES, LP - Northfield | OJH | |
| Z-1121-2023 | Class II | Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Number... | MEDLINE INDUSTRIES, LP - Northfield | OIB | |
| Z-1120-2023 | Class II | Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder... | MEDLINE INDUSTRIES, LP - Northfield | MCY | |
| Z-1119-2023 | Class II | Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION... | MEDLINE INDUSTRIES, LP - Northfield | LRP | |
| Z-1118-2023 | Class II | Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number... | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-1117-2023 | Class II | Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY, Reorder... | MEDLINE INDUSTRIES, LP - Northfield | KDD | |
| Z-1116-2023 | Class II | Surgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Number DYNDA2489 | MEDLINE INDUSTRIES, LP - Northfield | FTN | |
| Z-1115-2023 | Class II | Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS TRACHEOSTOMY TRAY... | MEDLINE INDUSTRIES, LP - Northfield | OGR | |
| Z-1114-2023 | Class II | Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number... | MEDLINE INDUSTRIES, LP - Northfield | OFG | |
| Z-1113-2023 | Class II | Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PICC TRAY... | MEDLINE INDUSTRIES, LP - Northfield | OFF | |
| Z-1112-2023 | Class II | Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827 | MEDLINE INDUSTRIES, LP - Northfield | OEZ | |
| Z-1111-2023 | Class II | Surgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number... | MEDLINE INDUSTRIES, LP - Northfield | OES | |
| Z-1110-2023 | Class II | Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN, Reorder... | MEDLINE INDUSTRIES, LP - Northfield | OEQ | |
| Z-1109-2023 | Class II | Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122A | MEDLINE INDUSTRIES, LP - Northfield | OFT | |
| Z-1098-2023 | Class II | Identity Shoulder System Resection Planer 35mm Resection Planer | Zimmer GmbH | HTO | |
| Z-1007-2023 | Class II | Single-Use Packs, REF: OPO80 | Advanced Medical Optics, Inc. | HQC | |
| Z-1006-2023 | Class II | FUSION Dual Pump Packs, REF: OPO73 | Advanced Medical Optics, Inc. | HQC | |
| Z-0950-2023 | Class II | IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000... | Siemens Healthcare Diagnostics Inc. | MSW | |
| Z-0949-2023 | Class II | IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000... | Siemens Healthcare Diagnostics Inc. | MSW | |
| Z-0884-2023 | Class I | Philips Garbin Ventilator, Model Number 1058180B | Respironics, Inc. | CBK | |
| Z-0883-2023 | Class I | Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B... | Respironics, Inc. | CBK | |
| Z-0882-2023 | Class I | Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B... | Respironics, Inc. | CBK | |
| Z-1005-2023 | Class II | Veritas Advanced Infusion Packs, REF: VRT-AI | Advanced Medical Optics, Inc. | HQC | |
| Z-0957-2023 | Class II | MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system. | Brainlab, Inc. | JAK | |
| Z-0924-2023 | Class II | Pediatric Craniotome Ref:CRANI-P-G1 | The Anspach Effort, Inc. | HBC | |
| Z-0923-2023 | Class II | 6.5 cm Pediatric Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref... | The Anspach Effort, Inc. | HBC | |
| Z-0922-2023 | Class II | 7.5 cm Large Rotating Craniotome Attachment. Use with XMax, microMax, and eMax... | The Anspach Effort, Inc. | HBC | |
| Z-0921-2023 | Class II | Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including... | The Anspach Effort, Inc. | HBC | |
| Z-0920-2023 | Class II | 7.5 cm Large Craniotome Attachment Use with XMax, microMax, and eMax Systems. Ref... | The Anspach Effort, Inc. | HBC | |
| Z-0919-2023 | Class II | 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax... | The Anspach Effort, Inc. | HBC | |
| Z-0918-2023 | Class II | Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the... | The Anspach Effort, Inc. | HBC |