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-0741-04 | FreshLook Colors, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Rx... | Alcon Laboratories | LPM | ||
| Z-0740-04 | FreshLook ColorBlends, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5... | Alcon Laboratories | LPM | ||
| Z-0790-04 | Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall... | Boston Scientific Corporation | DQR | ||
| Z-0934-04 | AMPLICOR HPV Microwell Plate Analyte Specific Reagent (MWP); catalog 03579229190. | Roche Diagnostics GmbH | |||
| Z-0933-04 | AMPLICOR HPV Master Mix Analyte Specific Reagent (HPV MMX), Catalog number 03582841190. | Roche Diagnostics GmbH | |||
| Z-0758-04 | Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter... | Baxter Healthcare Renal Div | KDI | ||
| Z-1576-05 | ELx800 microtiter plate reader software program written for use with ORTHO HCV Version... | Diasorin Inc. | MZO | ||
| Z-0785-04 | BD L-Cath EX (28ga x 20cm), L-Cath Catheter System | Becton Dickinson Infusion Therapy Systems Inc. | LJS | ||
| Z-0784-04 | BD L-Cath EX (20ga x 15cm), L-Cath Catheter System | Becton Dickinson Infusion Therapy Systems Inc. | LJS | ||
| Z-0783-04 | BD L-Cath NN (24ga x 30cm), L-Cath Catheter System | Becton Dickinson Infusion Therapy Systems Inc. | LJS | ||
| Z-0787-04 | Philips Brilliance CT Scanner System, 6, 10 & 16 slice images. | Philips North America LLC | JAK | ||
| Z-1038-04 | Ant-Cer Dynamic Cervical Plating System Literature. Device is manufactured by Spinal... | Spinal Concepts, Inc. | KWQ | ||
| Z-0726-04 | Hill Rom brand Advanta bed; model P1600. | Hill-Rom Inc. | FNL | ||
| Z-0786-04 | Philips MX8000 IDT CT Scanner System, 10 & 16 slice images. | Philips North America LLC | JAK | ||
| Z-1052-05 | PICC Custom Kit GENESIS MEDICAL CENTER, 4.5F Dual Lumen , Catalog #60M120522. UPN... | Boston Scientific Corporation | LJS | ||
| Z-1051-05 | PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CKMS, Material Number... | Boston Scientific Corporation | LJS | ||
| Z-1050-05 | PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CKIR, Material Number... | Boston Scientific Corporation | LJS | ||
| Z-1049-05 | PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CK, Material Number M001PIC402CK0... | Boston Scientific Corporation | LJS | ||
| Z-0998-04 | Tecan clinical workstation; Tecan Genesis 150 back end, Roche catalog number 03585352001. | Roche Diagnostics GmbH | JQW | ||
| Z-0997-04 | Tecan clinical workstation; Tecan Genesis 150/8 TCW front end COBAS (FEC), Roche catalog... | Roche Diagnostics GmbH | JQW | ||
| Z-0996-04 | Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001. | Roche Diagnostics GmbH | JQW | ||
| Z-0760-04 | VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (5... | Boston Scientific Corporation | DRE | ||
| Z-0759-04 | VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (4... | Boston Scientific Corporation | DRE | ||
| Z-0810-04 | Magnum II Bariatric Patient Care System | Hill-Rom Manufacturing, Inc. | FNL | ||
| Z-0730-04 | Vision Hollow Fiber Oxygenator with GBS Coating | Gish Biomedical, Inc. | DTZ | ||
| Z-0737-04 | ACL Advance Instrument Analyzer | Instrumentation Laboratory Co. | JPA | ||
| Z-0736-04 | ACL Futura Instrument Analyzer | Instrumentation Laboratory Co. | JPA | ||
| Z-0950-04 | Stylus Brand Angled Knives - 52-2912, Slit Knife, parallel sides, bevel up, angled, full... | Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. | HNN | ||
| Z-0949-04 | Stylus Brand Angled Knife - 54-1010, Sharptome Crescent Knife, bevel up, angled, full... | Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. | HNN | ||
| Z-0948-04 | Stylus Brand Angled Knife 52-2931, Slit Knife, double bevel, angled, full handle... | Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. | HNN | ||
| Z-0947-04 | Stylus Brand Angled Knife - 52-2661, Slit Knife, bevel up, angled full handled... | Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. | HNN | ||
| Z-0946-04 | Stylus Angled Knife - 56-5361, Pilot Tip Knife, bevel up, angled, full handled, 3.2mm and... | Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. | HNN | ||
| Z-0945-04 | Stylus Angled Knife - 52-2835 Clear Corneal Knife, double bevel, parallel sides, angled... | Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. | HNN | ||
| Z-0916-04 | Philips Pinnacle3 Version 6.4a Radiation Therapy Planning Software CD, Part Number... | Philips North America LLC | MUJ | ||
| Z-0915-04 | Philips ADAC Pinnacle3 Version 6.4a Radiation Therapy Planning Software Package (Kit)... | Philips North America LLC | MUJ | ||
| Z-0914-04 | Pinnacle3 Radiation Therapy Planning System, Version 6.6c CD, Part Number... | Philips North America LLC | MUJ | ||
| Z-0913-04 | Pinnacle3 Radiation Therapy Planning System, Version 7.0e CD, Part Number Part #... | Philips North America LLC | MUJ | ||
| Z-0912-04 | Pinnacle3 Radiation Therapy Planning System, Version 6.6c Kit, Model Number 9200-0613C-ENG | Philips North America LLC | MUJ | ||
| Z-0911-04 | Pinnacle3 Radiation Therapy Planning System, Version 7.0e Kit, Model Number 9200-9052A-ENG | Philips North America LLC | MUJ | ||
| Z-0910-04 | Medtronic MiniMed Paradigm Quick-set Plus Infusion Sets. Models MMT-359S6; MMT-359S9... | Medtronic, Inc. | FPA | ||
| Z-0952-04 | BioPince Full Core Biopsy Instrument packed in aTyvek/plastic blister pack which is... | Medical Device Technologies, Inc. | GAA | ||
| Z-0773-04 | Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing... | Siemens Healthcare Diagnostics Inc. | GFO | ||
| Z-0808-04 | 1757-1: Compressor/Distractor Instrument (aka Plate Distractor Forceps), and product... | Spinal Concepts, Inc. | KWQ | ||
| Z-0807-04 | One-level Ant-Cer Plates (Assembly Level). 1706-1024, 1706-1026, 1706-1028, 1706-1030... | Spinal Concepts, Inc. | KWQ | ||
| Z-0703-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 4.5 cm length, Item... | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0702-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 4.0 cm length, Item... | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0701-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 3.5 cm length, Item... | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0700-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 3.0 cm length, Item... | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0699-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 2.7 cm length, Item... | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0698-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 2.5 cm length, Item... | Ross Products Division Abbott Laboratories | KNT |