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-2398-2011 | ES0120, AEM Disposable Low Profile Scissors, 3/4", 35cm, Sterile R, Encision Inc... | Encision, Inc. | GEI | ||
| Z-2397-2011 | ES0110, AEM Disposable Hook Scissors, 35cm, Sterile R, Encision Inc., Boulder, CO 80301... | Encision, Inc. | GEI | ||
| Z-2396-2011 | ES0102, AEM Disposable Curved Scissors, 3/4", 35cm, Sterile R, Encision Inc., Boulder, CO... | Encision, Inc. | GEI | ||
| Z-2395-2011 | ES0101, AEM Disposable Curved Scissors, 1/2", 35cm, Sterile R, Encision Inc., Boulder, CO... | Encision, Inc. | GEI | ||
| Z-2248-2011 | Philips Microstream Model 989803159581 VITALINE H SET INFANT/NEONATAL 25 UN... | Philips North America LLC | CCK | ||
| Z-2247-2011 | Philips Microstream Model M1923A FILTERLINE H SET INF/NEO 25UN PHILIPS These products... | Philips North America LLC | CCK | ||
| Z-2221-2011 | Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Use Before... | Merz North America, Inc. | LMH | ||
| Z-2181-2011 | Varian Medical System TrueBeam system for stereotactic radiosurgery and radiotherapy... | Varian Medical Systems, Inc. | IYE | ||
| Z-2132-2011 | Synchron LXi 725, Part Number: 476501. Designed for the in vitro determination of a... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-2131-2011 | Synchron LX20 PRO, Part Number: 476100. Designed for the in vitro determination of a... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-2130-2011 | Synchron LX20, Part Number: 466200. Designed for the in vitro determination of a variety... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-2246-2011 | IMPAX 6.5 Client Software. IMPAX 6.5 combines the traditional activities of RIS... | AGFA Healthcare Corp. | LLZ | ||
| Z-2223-2011 | V-CATH Insertion Kits, Sterile; Product Code Number: 301-00; Manufactured by Centurion... | Neo Medical, Inc. | LRS | ||
| Z-1940-2013 | Class II | GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is... | GE Healthcare | JAK | |
| Z-2697-2011 | RUSCH Percutwist Set with Crystal Clear Sterile Crystal Clear Tracheostomy Tube is a... | Teleflex Medical | JOH | ||
| Z-2696-2011 | RUSCH Crystal Clear PDT, Sterile Crystal Clear Tracheostomy Tube is a device inserted... | Teleflex Medical | JOH | ||
| Z-2695-2011 | RUSCH CrystalClear Tracheostomy Tube, Cuffed, Sterile Pack Crystal Clear Tracheostomy... | Teleflex Medical | JOH | ||
| Z-2220-2011 | Eclipse Treatment Planning System, Client software versions 8.0 through 8.6; Model... | Varian Medical Systems, Inc. | MUJ | ||
| Z-2751-2011 | Brand REMOVE Universal Adhesive Remover Wipe - Pouch Label and 50 count box Label... | Smith & Nephew, Inc. | KOX | ||
| Z-2750-2011 | Brand: UNI-SOLVE Adhesive Remover Wipe Pouch, 50 Count Box... | Smith & Nephew, Inc. | KOX | ||
| Z-2749-2011 | BRAND: SKIN-PREP - Pouch Labeling and Box / Carton Labeling ***smith&nephew... | Smith & Nephew, Inc. | NEC | ||
| Z-2748-2011 | smith&nephew NO-STING SKIN-PREP No-Sting Protective Wipes Effective protection between... | Smith & Nephew, Inc. | KMF | ||
| Z-2120-2011 | Medtronic, Kappa 600 KDR600,KDR601,KDR603,KDR606,KDR651,KDR653 The devices are... | Medtronic, Inc. | NVZ | ||
| Z-2386-2011 | AC Power Adaptor (transformer), TENPAO Model U090100Q31; used with the Pump In Style... | Medela AG | OHH | ||
| Z-2705-2011 | Sequoia final driver closure top retention, non-sterile, REF 3384-2, Zimmer Spine... | Zimmer GmbH | HAO | ||
| Z-2050-2011 | VITEK 2 Gram Negative Susceptibility Card, AST-N184, REF 411 154, For In Vitro Diagnostic... | bioMerieux, Inc. | LON | ||
| Z-2049-2011 | VITEK 2 Gram Negative Susceptibility Card, AST-N183, REF 411 021, For In Vitro Diagnostic... | bioMerieux, Inc. | LON | ||
| Z-3258-2011 | ANGIODYNAMICS NANOKNIFE IRE GENERATOR, Catalog/REF No. 20300101, ANGIODYNAMICS, 603... | Boston Scientific Corporation | OAB | ||
| Z-0043-2012 | Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals... | EMD Millipore Corporation | KQC | ||
| Z-2741-2011 | JASMINE Full Body (Patient) Lift, electrically-powered device with a 500 lb. weight... | Invacare GmbH | FNG | ||
| Z-2401-2011 | Xpert Infinity Software, V 4.1a. Cepheid, Sunnyvale, CA 94089 system software for... | Cepheid | NJR | ||
| Z-3162-2011 | Ratcheting Torque Limiting Handle, Catalog Number 52-1012, Orthofix Spinal Implants... | Orthofix SRL | NKB | ||
| Z-2219-2011 | PercuNav Field Generator Stand is a Computed tomography, X-Ray System. Part Number... | Philips North America LLC | JAK | ||
| Z-2064-2011 | Defibtech Lifeline AED and ReviveR AED, Model: DDU-100 Series AEDs Software version... | Defibtech LLC | MKJ | ||
| Z-2484-2012 | Class II | 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14... | Zimmer GmbH | HWT | |
| Z-2483-2012 | Class II | 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14... | Zimmer GmbH | HWT | |
| Z-2482-2012 | Class II | 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14... | Zimmer GmbH | HWT | |
| Z-2481-2012 | Class II | 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14... | Zimmer GmbH | HWT | |
| Z-2480-2012 | Class II | 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14... | Zimmer GmbH | HWT | |
| Z-2479-2012 | Class II | 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14... | Zimmer GmbH | HWT | |
| Z-2478-2012 | Class II | 12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys... | Zimmer GmbH | HWT | |
| Z-2477-2012 | Class II | 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head... | Zimmer GmbH | HWT | |
| Z-2476-2012 | Class II | 12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys... | Zimmer GmbH | HWT | |
| Z-2475-2012 | Class II | 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head... | Zimmer GmbH | HWT | |
| Z-2474-2012 | Class II | 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head... | Zimmer GmbH | HWT | |
| Z-2473-2012 | Class II | 00789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head... | Zimmer GmbH | HWT | |
| Z-1178-2012 | Philips Healthcare EasyDiagnost Eleva DRF 4.0 Stationary X-Ray System with DRF as an... | Philips North America LLC | KPR | ||
| Z-2733-2011 | SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). This... | Abbott Medical | MXC | ||
| Z-2224-2011 | Varian brand Clinac and TrueBeam, High Energy Linear Accelerator, Model Numbers: H14... | Varian Medical Systems, Inc. | IYE | ||
| Z-2738-2011 | Large Roller Pump 6" Diameter, Catalog 801041, Terumo Cardiovascular Systems, Corp., Ann... | Terumo Cardiovascular Systems Corporation | DTQ |