510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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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

59,528 records, page 748 of 1191
FDA device recalls, page 748 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1828-2013Class IIMedline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code...Steritec Products Mfg. Co., Inc.JOJ
Z-1827-2013Class IIMesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25...Steritec Products Mfg. Co., Inc.FRC
Z-1826-2013Class IIGetinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25...Steritec Products Mfg. Co., Inc.FRC
Z-1825-2013Class IIGetinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395...Steritec Products Mfg. Co., Inc.FRC
Z-1824-2013Class IIEZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam...Steritec Products Mfg. Co., Inc.FRC
Z-1823-2013Class IICardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product...Steritec Products Mfg. Co., Inc.FRC
Z-1859-2013Class IIsyngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo Dynamics...Siemens Medical Solutions USA, Inc.LLZ
Z-1747-2013Class IIAfinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of...Staar Surgical AGHQL
Z-1746-2013Class IInanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in...Staar Surgical AGHQL
Z-1822-2013Class IIMedline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product...Steritec Products Mfg. Co., Inc.FRC
Z-1618-2013Class IIStatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only...Bard Access Systems, Inc.KMK
Z-1689-2013Class IIda Vinci Instrument Control Box, model number ICB3000; Manufactured by Intuitive...Intuitive Surgical, Inc.NAY
Z-1688-2013Class IIda Vinci Dual Camera Controller, model number DC3000; Manufactured by Intuitive...Intuitive Surgical, Inc.NAY
Z-1687-2013Class IIda Vinci Si Vision System Cart, model number VS3000; Manufactured by Intuitive Surgical...Intuitive Surgical, Inc.NAY
Z-1686-2013Class IIda Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical...Intuitive Surgical, Inc.NAY
Z-0593-2014Class IIPhilips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart...Philips North America LLCMKJ
Z-1771-2013Class IISpacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be...GE HealthcareCBK
Z-1724-2013Class IIREF 154239 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F7 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1723-2013Class IIREF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1722-2013Class IIREF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1721-2013Class IIREF 154236 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F4 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1720-2013Class IIREF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ARCOM UHMWPE /...Zimmer GmbHHRY
Z-1719-2013Class IIREF 154232 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E7 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1718-2013Class IIREF 154231Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E6 ARCOM UHMWPE /...Zimmer GmbHHRY
Z-1717-2013Class IIREF 154230 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E5 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1716-2013Class IIREF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1715-2013Class IIREF 154228 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E3 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1714-2013Class IIREF 154225Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D7 ARCOM UHMWPE /...Zimmer GmbHHRY
Z-1713-2013Class IIREF 154224 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D6 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1712-2013Class IIREF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D5 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1711-2013Class IIREF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D4 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1610-2013Class IIBrand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: Single day...Baxter Healthcare CorporationFRN
Z-1606-2013Class IIBrand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of...Baxter Healthcare CorporationFRN
Z-1605-2013Class IIBrand Name: SV Elastomeric Infusion Device. Indicated for the intravenous administration...Baxter Healthcare CorporationFRN
Z-1604-2013Class IIBrand Name: Intermate Infusion Pump. Indicated for the intravenous administration of...Baxter Healthcare CorporationFRN
Z-1603-2013Class IIBrand Name: Intermate Infusion Pump. Indicated for the intravenous administration of...Baxter Healthcare CorporationMEB
Z-1602-2013Class IIBrand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the...Baxter Healthcare CorporationMEB
Z-1601-2013Class IIBrand Name: Multirate Infusor Devices. Indicated for the intravenous administration of...Baxter Healthcare CorporationMEB
Z-1710-2013Class IIREF 154221 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D3 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1709-2013Class IIREF 154218 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C7 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1708-2013Class IIREF 154217 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C6 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1707-2013Class IIREF 154216 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C5 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1706-2013Class IIREF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1705-2013Class IIREF 154214 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C3 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1704-2013Class IIREF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B7 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1703-2013Class IIREF 154210 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size 6ARCOM UHMWPE /...Zimmer GmbHHRY
Z-1702-2013Class IIREF 154209 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B5 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1701-2013Class IIREF 154208 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B4 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1700-2013Class IIREF 154207 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B3 ARCOM UHMWPE...Zimmer GmbHHRY
Z-1699-2013Class IIREF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A7 ARCOM UHMWPE...Zimmer GmbHHRY