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-2940-2020 | Class II | Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024 | Medical Components, Inc. | MSD | |
| Z-2911-2020 | Class II | Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is intended for... | C.A. Greiner & Sohne Gesellschaftmbh | FMI | |
| Z-2897-2020 | Class II | Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US... | Karl Storz Endoscopy-America, Inc. | CAL | |
| Z-2896-2020 | Class II | Flexible Intubation Video Endoscope, Part: 11302BDX, with Instruction Manual: Z18443US... | Karl Storz Endoscopy-America, Inc. | CAL | |
| Z-2895-2020 | Class II | Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US... | Karl Storz Endoscopy-America, Inc. | CAL | |
| Z-2894-2020 | Class II | Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction Manual: Z18445US... | Karl Storz Endoscopy-America, Inc. | CAL | |
| Z-2893-2020 | Class II | Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z18445US... | Karl Storz Endoscopy-America, Inc. | CAL | |
| Z-2892-2020 | Class II | Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US... | Karl Storz Endoscopy-America, Inc. | CAL | |
| Z-2891-2020 | Class II | Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction Manual: Z18444US... | Karl Storz Endoscopy-America, Inc. | CAL | |
| Z-2890-2020 | Class II | Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US... | Karl Storz Endoscopy-America, Inc. | CAL | |
| Z-2847-2020 | Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit... | Datascope Corp. | DSP | |
| Z-2846-2020 | Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit... | Datascope Corp. | DSP | |
| Z-2845-2020 | Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit... | Datascope Corp. | DSP | |
| Z-2844-2020 | Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit... | Datascope Corp. | DSP | |
| Z-2843-2020 | Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit... | Datascope Corp. | DSP | |
| Z-2842-2020 | Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product... | Datascope Corp. | DSP | |
| Z-2841-2020 | Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N... | Datascope Corp. | DSP | |
| Z-2840-2020 | Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N... | Datascope Corp. | DSP | |
| Z-2839-2020 | Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N... | Datascope Corp. | DSP | |
| Z-2838-2020 | Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N... | Datascope Corp. | DSP | |
| Z-2837-2020 | Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N... | Datascope Corp. | DSP | |
| Z-2836-2020 | Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N... | Datascope Corp. | DSP | |
| Z-2835-2020 | Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N... | Datascope Corp. | DSP | |
| Z-2834-2020 | Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N... | Datascope Corp. | DSP | |
| Z-2833-2020 | Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N... | Datascope Corp. | DSP | |
| Z-2832-2020 | Class II | Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N... | Datascope Corp. | DSP | |
| Z-2831-2020 | Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N... | Datascope Corp. | DSP | |
| Z-0050-2021 | Class II | DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use... | Ra Medical Systems,Inc | PDU | |
| Z-2921-2020 | Class II | Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2... | Siemens Medical Solutions USA, Inc. | DQK | |
| Z-2927-2020 | Class II | Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro... | Siemens Healthcare Diagnostics Inc. | MMI | |
| Z-0069-2021 | Class II | NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter... | NuVasive Specialized Orthopedics, Inc. | HSB | |
| Z-2798-2020 | Class II | Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barricaid ACD is... | Intrinsic Therapeutics, Inc. | QES | |
| Z-2920-2020 | Class II | Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number... | Remel Europe Ltd. | GOY | |
| Z-2357-2021 | Class II | CombiDiagnost R90 Software Version R1.0 and R1.1 | Philips Medical Systems DMC GmbH | JAA | |
| Z-2871-2020 | Class II | ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15 | Globus Medical, Inc. | MAX | |
| Z-2870-2020 | Class II | ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15 | Globus Medical, Inc. | MAX | |
| Z-2869-2020 | Class II | ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15 | Globus Medical, Inc. | MAX | |
| Z-2868-2020 | Class II | ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8 | Globus Medical, Inc. | MAX | |
| Z-2867-2020 | Class II | ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8 | Globus Medical, Inc. | MAX | |
| Z-2866-2020 | Class II | ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8 | Globus Medical, Inc. | MAX | |
| Z-2865-2020 | Class II | ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8 | Globus Medical, Inc. | MAX | |
| Z-2864-2020 | Class II | ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15 | Globus Medical, Inc. | MAX | |
| Z-2863-2020 | Class II | ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15 | Globus Medical, Inc. | MAX | |
| Z-2862-2020 | Class II | ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15 | Globus Medical, Inc. | MAX | |
| Z-2861-2020 | Class II | ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8 | Globus Medical, Inc. | MAX | |
| Z-2860-2020 | Class II | ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8 | Globus Medical, Inc. | MAX | |
| Z-2859-2020 | Class II | ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8 | Globus Medical, Inc. | MAX | |
| Z-2858-2020 | Class II | ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8 | Globus Medical, Inc. | MAX | |
| Z-2857-2020 | Class II | ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15 | Globus Medical, Inc. | MAX | |
| Z-2856-2020 | Class II | ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15 | Globus Medical, Inc. | MAX |