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-0224-2008 | Stryker Advantage Series Emergency Care wheeled stretcher, Model 1001, Stryker Medical... | Stryker Medical | FPO | ||
| Z-0223-2008 | Stryker Transport wheeled stretcher, Model 735 (ST104), Stryker Medical, Portage, MI 49002 | Stryker Medical | FPO | ||
| Z-0222-2008 | Stryker OEM wheeled stretcher, Model 722, Stryker Medical, Portage, MI 49002 | Stryker Medical | FPO | ||
| Z-0221-2008 | Stryker Transport wheeled stretcher, Model 721, Stryker Medical, Portage, MI 49002 | Stryker Medical | FPO | ||
| Z-0220-2008 | Stryker Transport wheeled stretcher, Model 720, Stryker Medical, Portage, MI 49002 | Stryker Medical | FPO | ||
| Z-0219-2008 | Stryker Zoom (Atlas) powered patient transport stretcher, Model 660, Stryker Medical... | Stryker Medical | FPO | ||
| Z-0400-05 | Powerheart AED G3 Automated External Defibrillator Model 9300P Professional series)... | ZOLL Medical Corporation | MKJ | ||
| Z-0399-05 | Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac... | ZOLL Medical Corporation | NPN | ||
| Z-0398-05 | Powerheart AED G3 Automated External Defibrillator Model 9300E. Cardiac Science AEDs are... | ZOLL Medical Corporation | MKJ | ||
| Z-0373-05 | StreamLab Analytical Workcell. General Purpose Laboratory Device. | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0338-05 | 10 French Ross Flexiflo Lap J Laparoscopic Jejunostomy Kit with Brown/Mueller T-Fastner... | Abbott Medical | LNO | ||
| Z-0337-05 | 20 French Flexiflo Inverta-PEG Pull Technique Basic Gastrostomy KIt with Roll-Tip Bumper... | Abbott Medical | LNO | ||
| Z-0336-05 | 20 French Ross Inverta-PEG Over-the-Guidewire Basic Gastrostomy KIt with Roll-Tip Bumper... | Abbott Medical | LNO | ||
| Z-0335-05 | 20 French Ross Flexiflo Over-the-Guidewire Complete Gastrostomy KIt with Reinforced... | Abbott Medical | LNO | ||
| Z-0334-05 | 20 French Ross Over-the-Guidewire Basic Gastrostomy KIt with Reinforced Webbed Bumper... | Abbott Medical | LNO | ||
| Z-0333-05 | 22 French Ross Versa-PEG Complete Gastrostomy Kit, an Over-the-Wire PEG Method Featuring... | Abbott Medical | LNO | ||
| Z-0332-05 | 18 French Ross Introducer Complete Gastrostomy Kit with Brown/Mueller T-Fastener Set... | Abbott Medical | LNO | ||
| Z-0331-05 | 18 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners for... | Abbott Medical | LNO | ||
| Z-0330-05 | 18 French Ross Flexiflo Over the Guidewire Gastrostomy Basic Kit with T-Fasteners for... | Abbott Medical | LNO | ||
| Z-0329-05 | 14 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners (15cm) for... | Abbott Medical | LNO | ||
| Z-0328-05 | 18 French Ross Flexiflo Lap J Laparoscopic Jejunostomy Kit with Brown/Mueller T-Fastener... | Abbott Medical | LNO | ||
| Z-0327-05 | 14 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners (15cm) for... | Abbott Medical | LNO | ||
| Z-0271-05 | Linear Array Transducer Type: 8809 | B & K Medical Systems, Inc. | IYN | ||
| Z-0347-05 | Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial... | Exactech, Inc. | JWH | ||
| Z-0442-05 | Deltec branded PORT-A-CATH II Single-Lumen Low Profile Polysulfone/Titanium Venous Access... | Abbott Medical | LJT | ||
| Z-0278-05 | Medtronic Midas Rex Legend High Speed Pneumatic System | Medtronic Powered Surgical Solutions | HBB | ||
| Z-0396-05 | Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System | Advanced Bionics LLC | LGW | ||
| Z-0300-05 | Straumann Dental Implant System, SP Profile Drill, Short, 04.2 mm, RN, L25.0 mm... | Straumann USA, LLC | NDP | ||
| Z-0378-05 | The product is refill heads for battery powered toothbrushes. Spinbrush Pro Whitening... | The Procter & Gamble Co./THE GILLETTE Company | JEQ | ||
| Z-0377-05 | The product is refill heads for battery powered toothbrushes. Spinbrush Pro Whitening EX... | The Procter & Gamble Co./THE GILLETTE Company | JEQ | ||
| Z-0376-05 | The product is battery powered toothbrush. Spinbrush Pro Whitening Medium battery... | The Procter & Gamble Co./THE GILLETTE Company | JEQ | ||
| Z-0375-05 | The product is battery powered toothbrush. Spinbrush Pro Whitening Ex Soft battery... | The Procter & Gamble Co./THE GILLETTE Company | JEQ | ||
| Z-0568-05 | Model 8100 Series Medley Medication Safety System Pump Module | CareFusion 303, Inc | FRN | ||
| Z-0258-05 | Alsius CoolGard 3000 patient temperature regulation system | Alsius Corp. | NCX | ||
| Z-0308-05 | Easy Go Vac Aspirator, Model PM65HG. Portable suction unit | Precision Medical, Inc. | BTA | ||
| Z-0307-05 | Easy Go Vac Aspirator, Model PM65. Portable suction unit | Precision Medical, Inc. | BTA | ||
| Z-0265-05 | Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer. | Siemens Healthcare Diagnostics Inc. | CGN | ||
| Z-0301-05 | Baxter CAPD Solution Transfer Set for use with UV-Flash Germicidal Exchange Device, 1.2 m... | Baxter Healthcare Renal Div | KDJ | ||
| Z-0297-05 | MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001. | Roche Diagnostics GmbH | NPQ | ||
| Z-0267-05 | DL2000 Data Manager Software, Version 6.4.108 | Siemens Healthcare Diagnostics Inc. | JQP | ||
| Z-0374-05 | Warm Air Model 135 Warming Units. | Gentherm Medical, LLC | BTE | ||
| Z-0264-05 | 3M nexcare First Aid HoldFast Roll Gauze cat # HR-2R Lot # 4267. 3M Health Care St... | 3M Company | FRO | ||
| Z-0345-05 | Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163 and 2M8163R... | Baxter Healthcare Corporation | FRN | ||
| Z-0344-05 | Colleague CX Single Channel Volumetric Infusion Pumps, product code 2M8161and 2M8161R... | Baxter Healthcare Corporation | FRN | ||
| Z-0343-05 | Colleague 3 Triple Channel Volumetric Infusion Pumps, product code 2M8153 and 2M8153R... | Baxter Healthcare Corporation | FRN | ||
| Z-0342-05 | Colleague Single Channel Volumetric Infusion Pumps, product code 2M8151and 2M8151R... | Baxter Healthcare Corporation | FRN | ||
| Z-0720-05 | Site Rite II, Site Rite 3, and Site Rite IV Systems with 2 Sterile Kits each. | Bard Access Systems, Inc. | ITX | ||
| Z-0206-05 | AccessAED PAD Package (without ECG trace) Model Number: 9100-0015-0 | Access Cardiosystems, Inc. | MKJ | ||
| Z-0205-05 | AccessAED PAD (without ECG trace) -Public Access Defibrillator Model Number: 9100-0010-0 | Access Cardiosystems, Inc. | MKJ | ||
| Z-0204-05 | AccessALS Package Model Number: 9100-0150-2 | Access Cardiosystems, Inc. | MKJ |