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-0789-2023 | Class II | Vitek 2 Reagent Yst Test Kit Vtk2 20 Cards, Catalog 21343 | bioMerieux, Inc. | JXB | |
| Z-0788-2023 | Class II | Vitek 2 Reagent Gp Test Kit Vtk2 20 Cards, Catalog 21342 | bioMerieux, Inc. | LQL | |
| Z-0787-2023 | Class II | Vitek 2 Reagent Gn Test Kit Vtk2 20 Cards, Catalog 21341 | bioMerieux, Inc. | LQM | |
| Z-0786-2023 | Class II | Api Staph 25 Strips+25 Media, Catalog 20500 | bioMerieux, Inc. | JWX | |
| Z-0785-2023 | Class II | Api 20 C Aux 25 Strips+25 Media, Catalog 20210 | bioMerieux, Inc. | JXB | |
| Z-0784-2023 | Class II | Api 20 E 25 Strips, Catalog 20100 | bioMerieux, Inc. | JSS | |
| Z-0783-2023 | Class II | Api Listeria 10 Strips+10 Media, Catalog 10300 | bioMerieux, Inc. | JTO | |
| Z-0578-2026 | Class II | FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0 | Foundation Medicine, Inc. | PQP | |
| Z-0577-2026 | Class II | FoundationOne CDx (F1CDx), RAL-0003 version 31.0 | Foundation Medicine, Inc. | PQP | |
| Z-0774-2023 | Class II | 9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part... | Endo USA | MDM | |
| Z-0727-2023 | Class II | Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615 | Corin Limited | LZO | |
| Z-0726-2023 | Class II | Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215 | Corin Limited | LZO | |
| Z-0741-2023 | Class II | InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA... | Companion Medical, Inc. | NDC | |
| Z-0737-2023 | Class III | Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to... | Howmedica Osteonics Corp | LOD | |
| Z-0736-2023 | Class III | Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to... | Howmedica Osteonics Corp | LOD | |
| Z-0720-2023 | Class II | Cordis Angiographic Catheter Extensions. Used to transport fluid from the power... | Cordis US Corp. | DQO | |
| Z-0999-2023 | Class III | R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501... | R & D Systems, Inc. | JPK | |
| Z-0422-2023 | Class II | Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code... | Maquet Cardiovascular Us Sales, LLC | BSZ | |
| Z-0751-2023 | Class II | Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction... | Medical Action Industries, Inc. 306 | OFD | |
| Z-0718-2023 | Class II | IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material... | Siemens Healthcare Diagnostics Inc. | DHB | |
| Z-0717-2023 | Class II | IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except... | Siemens Healthcare Diagnostics Inc. | DHB | |
| Z-0716-2023 | Class II | IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens... | Siemens Healthcare Diagnostics Inc. | DHB | |
| Z-0424-2023 | Class II | HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S | OLYMPUS Corporation of the Americas | FJL | |
| Z-0715-2023 | Class II | DeRoyal CATARACT PACK, REF 89-10086.05 | DeRoyal Industries, Inc. | LRO | |
| Z-0714-2023 | Class II | DeRoyal CATARACT PACK, REF 89-10040.01 | DeRoyal Industries, Inc. | LRO | |
| Z-0713-2023 | Class II | DeRoyal CATARACT PACK, REF 89-9241.04 | DeRoyal Industries, Inc. | LRO | |
| Z-0712-2023 | Class II | DeRoyal CATARACT PACK, REF 89-9241.03 | DeRoyal Industries, Inc. | LRO | |
| Z-0711-2023 | Class II | DeRoyal CATARACT PACK, REF 89-8859.08 | DeRoyal Industries, Inc. | LRO | |
| Z-0710-2023 | Class II | DeRoyal CATARACT PACK, REF 89-8650.10 | DeRoyal Industries, Inc. | LRO | |
| Z-0709-2023 | Class II | Geo-Med Cataract Pack, Ref 89-5790.08 | DeRoyal Industries, Inc. | LRO | |
| Z-0708-2023 | Class II | DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02 | DeRoyal Industries, Inc. | LRO | |
| Z-0707-2023 | Class II | DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02 | DeRoyal Industries, Inc. | LRO | |
| Z-0706-2023 | Class II | DeRoyal TRACECART SHOULDER ARTHROSCOPY TRACECART, REF 53-1962.02 | DeRoyal Industries, Inc. | LRO | |
| Z-0728-2023 | Class II | VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702 | Icotec AG | NKB | |
| Z-0705-2023 | Class II | DeRoyal BIOPSY PACKPACK, REF 89-9756.05 | DeRoyal Industries, Inc. | LRO | |
| Z-0704-2023 | Class II | DeRoyal TOTAL KNEE PACK A & B PACK, REF 89-6799.02 | DeRoyal Industries, Inc. | LRO | |
| Z-0703-2023 | Class II | DeRoyal PACEMAKER ICD PACK, REF 89-10902.01 | DeRoyal Industries, Inc. | LRO | |
| Z-0702-2023 | Class II | DeRoyal NEURO SPINE BACK PACK PGYBK, REF 89-10853.01 | DeRoyal Industries, Inc. | LRO | |
| Z-0701-2023 | Class II | DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10820.02 | DeRoyal Industries, Inc. | LRO | |
| Z-0700-2023 | Class II | Geo-Med Local Anesthesia Pack, Ref 89-10800.01 | DeRoyal Industries, Inc. | LRO | |
| Z-0699-2023 | Class II | DeRoyal LAMI/CRANI PACK, REF 89-10787.01 | DeRoyal Industries, Inc. | LRO | |
| Z-0698-2023 | Class II | DeRoyal NEURO PACK, REF 89-10682.02 | DeRoyal Industries, Inc. | LRO | |
| Z-0697-2023 | Class II | DeRoyal GU PACK, REF 89-10665.03 | DeRoyal Industries, Inc. | LRO | |
| Z-0696-2023 | Class II | DeRoyal GU PACK, REF 89-10665.02 | DeRoyal Industries, Inc. | LRO | |
| Z-0695-2023 | Class II | DeRoyal ANTERIOR APPROACH TOTAL HIP A&B PGYBK, REF 89-10612.01 | DeRoyal Industries, Inc. | LRO | |
| Z-0694-2023 | Class II | DeRoyal LUMBAR DISC PACK, REF 89-10605.02 | DeRoyal Industries, Inc. | LRO | |
| Z-0693-2023 | Class II | DeRoyal LUMBAR DISC PACK, REF 89-10590.02 | DeRoyal Industries, Inc. | LRO | |
| Z-0692-2023 | Class II | DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01 | DeRoyal Industries, Inc. | LRO | |
| Z-0691-2023 | Class II | DeRoyal CARDIAC LINEN PACK, REF 89-10543.02 | DeRoyal Industries, Inc. | LRO | |
| Z-0690-2023 | Class II | DeRoyal CNRV SPINAL PACK, REF 89-10532.03 | DeRoyal Industries, Inc. | LRO |