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-0880-06 | Stratus CS STAT Fluorometric Analyzer BHCG DilPak (CBHCG-D) in vitro diagnostic. | Siemens Healthcare Diagnostics Inc. | DHA | ||
| Z-0879-06 | Stratus CS STAT Fluorometric Analyzer Acute Care pBNP TestPak (CpBNP) in vitro diagnostic. | Siemens Healthcare Diagnostics Inc. | NBC | ||
| Z-0878-06 | Stratus CS STAT Fluorometric Analyzer MYO TestPak (CMYO) in vitro diagnostic. | Siemens Healthcare Diagnostics Inc. | DDR | ||
| Z-0877-06 | Stratus CS STAT Fluorometric Analyzer DDMR TestPak (CDDMR) in vitro diagnostic. | Siemens Healthcare Diagnostics Inc. | DAP | ||
| Z-0876-06 | Stratus CS STAT Fluorometric Analyzer Acute Care cTnI TestPak (CCTNI) in vitro diagnostic. | Siemens Healthcare Diagnostics Inc. | MMI | ||
| Z-0875-06 | Stratus CS STAT Fluorometric Analyzer CKMB TestPak (CCKMB) in vitro diagnostic. | Siemens Healthcare Diagnostics Inc. | JHX | ||
| Z-0874-06 | Stratus CS STAT Fluorometric Analyzer BHCG TestPak (CBHCG) in vitro diagnostic. | Siemens Healthcare Diagnostics Inc. | DHA | ||
| Z-1146-06 | Disetronic Ultraflex 10/110 infusion set; (Distributed outside of the US only). | Disetronic Medical Systems | LZG | ||
| Z-1145-06 | Disetronic Ultraflex 8/110 infusion set; (Distributed outside of the US only). | Disetronic Medical Systems | LZG | ||
| Z-1144-06 | Disetronic Ultraflex 8/80 infusion set; Catalog number 4489039001. (Distributed outside... | Disetronic Medical Systems | LZG | ||
| Z-1143-06 | Disetronic Ultraflex 8/60 infusion set; (Distributed outside of the US only). | Disetronic Medical Systems | LZG | ||
| Z-1142-06 | Accu-Chek Ultraflex soft DUS 1 infusion set; 8 mm (60 cm); Catalog number 3765512001... | Disetronic Medical Systems | LZG | ||
| Z-1141-06 | Accu-Chek Ultraflex-10 infusion set; Catalog number 454479001. | Disetronic Medical Systems | LZG | ||
| Z-1140-06 | Accu-Chek Ultraflex-8 infusion set; Catalog number 4544773001. | Disetronic Medical Systems | LZG | ||
| Z-1139-06 | Accu-Chek Flexlink 1 infusion set; 10 mm (110 cm); Catalog number 4540905001... | Disetronic Medical Systems | LZG | ||
| Z-1138-06 | Accu-Chek Flexlink 1 infusion set; 10 mm (30 cm); Catalog number 4626494001... | Disetronic Medical Systems | LZG | ||
| Z-1137-06 | Accu-Chek Ultraflex-1 infusion set; 10 mm (30 cm); (Distributed outside the US only). | Disetronic Medical Systems | LZG | ||
| Z-1136-06 | Accu-Chek Ultraflex-1 infusion set; 8 mm (30 cm); (Distributed outside the US only). | Disetronic Medical Systems | LZG | ||
| Z-1135-06 | Accu-Chek FlexLink Cannula 10; Ref number 04541227001. (Distributed outside of the U.S... | Disetronic Medical Systems | LZG | ||
| Z-1134-06 | Accu-Chek FlexLink Cannula 8; Ref number 04541219001. (Distributed outside of the U.S... | Disetronic Medical Systems | LZG | ||
| Z-1133-06 | Accu-Chek FlexLink 1 infusion set; 10/80; Ref number 04540891001. (Distributed outside... | Disetronic Medical Systems | LZG | ||
| Z-1132-06 | Accu-Chek FlexLink 1 infusion set; 10/60; Ref number 04540875001. (Distributed outside... | Disetronic Medical Systems | LZG | ||
| Z-1131-06 | Accu-Chek FlexLink 1 infusion set; 8/110; Ref number 04540832001. (Distributed outside... | Disetronic Medical Systems | LZG | ||
| Z-1130-06 | Accu-Chek FlexLink 1 infusion set; 8/80; Ref number 04540816001. (Distributed outside of... | Disetronic Medical Systems | LZG | ||
| Z-1129-06 | Accu-Chek FlexLink 1 infusion set; 8/60; Ref number 04540794001. (Distributed outside of... | Disetronic Medical Systems | LZG | ||
| Z-1128-06 | Accu-Chek FlexLink 1 infusion set; 8/30; Ref number 04540778001. (Distributed outside of... | Disetronic Medical Systems | LZG | ||
| Z-1127-06 | Accu-Chek Ultraflex-2 infusion set; 10 mm 43'' (110 cm); Catalog number INF 04540972001. | Disetronic Medical Systems | LZG | ||
| Z-1126-06 | Accu-Chek Ultraflex-2 infusion set; 10 mm 31'' (80 cm); Catalog number INF 04540964001. | Disetronic Medical Systems | LZG | ||
| Z-1125-06 | Accu-Chek Ultraflex-2 infusion set; 10 mm 24'' (60 cm); Catalog number INF 04540956001. | Disetronic Medical Systems | LZG | ||
| Z-1124-06 | Accu-Chek Ultraflex-2 infusion set; 8 mm 43'' (110 cm); Catalog number INF 04540948001. | Disetronic Medical Systems | LZG | ||
| Z-1123-06 | Accu-Chek Ultraflex-2 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540930001. | Disetronic Medical Systems | LZG | ||
| Z-1122-06 | Accu-Chek Ultraflex-2 infusion set; 8 mm 24'' (60 cm); Catalog number INF 04540921001. | Disetronic Medical Systems | LZG | ||
| Z-1121-06 | Accu-Chek Ultraflex-1 infusion set; 10 mm 43'' (110 cm); Catalog number INF 04540905001. | Disetronic Medical Systems | LZG | ||
| Z-1120-06 | Accu-Chek Ultraflex-1 infusion set; 10 mm 31'' (80 cm); Catalog number INF 04540883001... | Disetronic Medical Systems | LZG | ||
| Z-1119-06 | Accu-Chek Ultraflex-1 infusion set; 10 mm 24'' (60 cm); Catalog number INF 04540867001. | Disetronic Medical Systems | LZG | ||
| Z-1118-06 | Accu-Chek Ultraflex-1 infusion set; 8 mm 43'' (110 cm); Catalog number INF 04540824001. | Disetronic Medical Systems | LZG | ||
| Z-1117-06 | Accu-Chek Ultraflex-1 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540808001... | Disetronic Medical Systems | LZG | ||
| Z-1116-06 | Accu-Chek Ultraflex 1-infusion set; 8 mm 24'' (60 cm); Catalog Number INF 04540786001. | Disetronic Medical Systems | LZG | ||
| Z-0886-06 | SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824. | Siemens Healthcare Diagnostics Inc. | LEH | ||
| Z-0840-06 | Straumann Narrow Neck (NN) Healing Cap with integral occlusal screw Height: 3.4mm Ref... | Straumann USA, LLC | DZE | ||
| Z-0777-06 | Proxima Sterile, Disposable Set Up Pack III, Reorder DYNJP1047; a sterilized convenience... | MEDLINE INDUSTRIES, LP - Northfield | LRO | ||
| Z-0792-06 | Synthes Resorbable Fixation Systems Resorbable Taps and Screws. Intended for use in... | Synthes (USA) Products LLC | JEY | ||
| Z-0787-06 | Aspergillus Niger Microbial Suspension, Model Numbers: 16404-100 (100 dose) and 16404-20... | Biological & Environmental Control Laboratories | JTR | ||
| Z-0807-06 | Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the... | Abbott Medical | MMP | ||
| Z-0806-06 | Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the... | Abbott Medical | MMP | ||
| Z-0805-06 | Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the... | Abbott Medical | MMP | ||
| Z-0804-06 | Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the... | Abbott Medical | MMP | ||
| Z-0803-06 | Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the... | Abbott Medical | MMP | ||
| Z-0802-06 | Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the... | Abbott Medical | MMP | ||
| Z-0801-06 | Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the... | Abbott Medical | MMP |