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-0860-05 | Pulmonary Valve & Conduit | Artivion, Inc. | MIE | ||
| Z-0859-05 | Aortic Valve & Conduit | Artivion, Inc. | MIE | ||
| Z-0920-05 | Carroll Healthcare brand Spirit bed; models BH2180-111AE, BH2180-111PE and BH2180-111FE. | Carroll Healthcare, Inc. | FNL | ||
| Z-0919-05 | Carroll Healthcare brand Arro bed models BA3180-151 AE, BA3180-151 PE, BA3180-151 FE... | Carroll Healthcare, Inc. | FNL | ||
| Z-1554-05 | The TRIO Spondylolisthesis Reduction Instrument is a Class I Manual Surgical Instrument... | Howmedica Osteonics Corp | MNH | ||
| Z-0974-05 | PG910 Spacers, Part number SP101, loaded into Bard Express Seeding Cartridges containing... | Theragenics Corp. | KXK | ||
| Z-1455-05 | Biomet Maxim SI knee instruments sliding femoral 4-in-1 block, 60 mm, stainless steel... | Zimmer GmbH | HTZ | ||
| Z-1454-05 | Biomet Maxim SI knee instruments sliding femoral 4-in-1 block 55 mm, stainless steel... | Zimmer GmbH | HTZ | ||
| Z-1453-05 | Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, x-large, stainless steel... | Zimmer GmbH | HTZ | ||
| Z-1452-05 | Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, large, stainless steel... | Zimmer GmbH | HTZ | ||
| Z-1451-05 | Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, medium, stainless steel... | Zimmer GmbH | HTZ | ||
| Z-1450-05 | Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, small, stainless steel... | Zimmer GmbH | HTZ | ||
| Z-1449-05 | Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, x-small, stainless steel... | Zimmer GmbH | HTZ | ||
| Z-1448-05 | Biomet Vanguard microplasty slidex femoral 4-in-1 block, 80 mm, stainless steel; Ref... | Zimmer GmbH | HTZ | ||
| Z-1447-05 | Biomet Vanguard microplasty slidex femoral 4-in-1 block, 62.5 mm, stainless steel; Ref... | Zimmer GmbH | HTZ | ||
| Z-1446-05 | Biomet Vanguard microplasty slidex femoral 4-in-1 block, 60 mm, stainless steel; Ref... | Zimmer GmbH | HTZ | ||
| Z-1445-05 | Biomet Vanguard microplasty slidex femoral 4-in-1 block, 57.5 mm, stainless steel; Ref... | Zimmer GmbH | HTZ | ||
| Z-0872-05 | Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 9.0mm Product Number... | Abbott Medical | JOH | ||
| Z-0871-05 | Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 8.0mm Product Number... | Abbott Medical | JOH | ||
| Z-0870-05 | Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 7.0mm Product Number... | Abbott Medical | JOH | ||
| Z-0869-05 | Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 9.0mm Product Number: 535090 | Abbott Medical | JOH | ||
| Z-0868-05 | Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 8.0mm Product Number: 535080 | Abbott Medical | JOH | ||
| Z-0867-05 | Portex Per-Fit Percutaneous Dilational Tracheostomy Kit ,ID 7.0mm Product Number: 535070 | Abbott Medical | JOH | ||
| Z-0897-05 | Dr. Fog Endoscopic fog prevention kit. | Aspen Surgical Products, Inc. | KOG | ||
| Z-0923-05 | Envisor, M2540 Diagnostic Ultrasound System | Philips North America LLC | IYN | ||
| Z-0938-05 | Misys Laboratory with Lab Access Results application for versions 5.3 and later. | CliniSys, Inc | JQP | ||
| Z-1556-05 | Product is a Powerflex P3 Dialation Catheter. Product is labeled in part: ''***POWERFLEX... | Cordis US Corp. | LIT | ||
| Z-0939-05 | Mysis Laboratory version 6.1 | CliniSys, Inc | JQP | ||
| Z-1403-05 | MyLab25 Ultrasound Imaging System; Model 9807300002. | Esaote North America, Inc | IYN | ||
| Z-1402-05 | MyLab30CV Ultrasound Imaging System; model 9807300001. | Esaote North America, Inc | IYN | ||
| Z-0865-05 | Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01), 9896 053... | Philips North America LLC | DPW | ||
| Z-0863-05 | Vail 2000 Enclosed Bed System. | Vail Products, Inc. | FNL | ||
| Z-0862-05 | Vail 1000 Enclosed Bed System. | Vail Products, Inc. | FNL | ||
| Z-0861-05 | Vail 500 Enclosed Bed System. | Vail Products, Inc. | FNL | ||
| Z-1401-05 | MyLab30CV Ultrasound Imaging System; model 9807300000. | Esaote North America, Inc | IYN | ||
| Z-0159-06 | Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare... | Baxter Healthcare Corporation | FRN | ||
| Z-0195-06 | LifeShield Latex-Free HEMA Blood PlumSet, Nonvented, 110 Inch with 210 Micron Filter... | Abbott Medical | BRZ | ||
| Z-2624-2010 | GMRS Extension Piece, 60 mm; Sterile Stryker Howmedica Osteonics; Howmedica Internation... | Howmedica Osteonics Corp | KRO | ||
| Z-1376-05 | UltraLite Vehicles powered by Rascal Motorized Vehicles. | Electric Mobility | ITI | ||
| Z-0858-05 | Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x1'' Catalog Number: 4238 | Abbott Medical | FMI | ||
| Z-0851-05 | Style 363 Saline-Filled BIOCELL textured Breast Implants | Allergan | FWM | ||
| Z-1369-05 | Power Processor 3060 Tube Refrigerated Stockyard, P/N 6915556. | Siemens Healthcare Diagnostics Inc. | LXG | ||
| Z-0905-05 | Virotek SAFEL*E*T 2.0 mm Safety Lancets, 2.0 mm depth, stock code 5000052, packaged in... | Efoora, Inc. dba Virotek, L.L.C. | FMK | ||
| Z-0904-05 | Virotek SAFEL*E*T 1.0 mm Safety Lancets, 1.0 mm depth, stock code 5000052, packaged in... | Efoora, Inc. dba Virotek, L.L.C. | FMK | ||
| Z-1087-05 | Baxter Sabraset 6060 Administration Set with Pre-attached 100 mL Bag and Cassette... | Baxter Healthcare Corporation | FPA | ||
| Z-1086-05 | Baxter Sabraset 6060 Administration Set with Pre-attached 250 mL Bag and Cassette... | Baxter Healthcare Corporation | FPA | ||
| Z-1553-05 | Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump, catalog #2M8064, 2M8064R... | Baxter Healthcare Corporation | FRN | ||
| Z-1552-05 | Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished)... | Baxter Healthcare Corporation | FRN | ||
| Z-0922-05 | Prostate Seeding Needle for Use with the Mick Applicator; an 18 gauge needle, 17 cm long... | Argon Medical Devices, Inc | KXK | ||
| Z-1113-05 | Roche Diagnostic HealthWear brand Professional System for weight management; Catalog #... | Roche Diagnostics GmbH | LYW |