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-0019-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-11, Product... | Riverpoint Medical, LLC | GAM | |
| Z-0018-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25... | Riverpoint Medical, LLC | GAM | |
| Z-0017-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-24, Product... | Riverpoint Medical, LLC | GAM | |
| Z-0016-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-14... | Riverpoint Medical, LLC | GAM | |
| Z-0015-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" V-20... | Riverpoint Medical, LLC | GAM | |
| Z-0014-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-12 Cutting... | Riverpoint Medical, LLC | GAM | |
| Z-0013-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34... | Riverpoint Medical, LLC | GAM | |
| Z-0012-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting... | Riverpoint Medical, LLC | GAM | |
| Z-0011-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting... | Riverpoint Medical, LLC | GAM | |
| Z-0010-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting... | Riverpoint Medical, LLC | GAM | |
| Z-0060-2021 | Class II | DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in... | Encore Medical, LP | MBH | |
| Z-0108-2021 | Class II | Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-2818-2020 | Class II | Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold... | Smith & Nephew, Inc. | GAD | |
| Z-2948-2020 | Class II | PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item... | Microport Orthopedics Inc. | LWJ | |
| Z-2942-2020 | Class I | PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip... | Microport Orthopedics Inc. | LWJ | |
| Z-2941-2020 | Class I | PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234... | Microport Orthopedics Inc. | LWJ | |
| Z-2881-2020 | Class II | Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC... | Klarity Medical Products LLC | IYE | |
| Z-2381-2021 | Class II | EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129 | Theratest Laboratories, Inc. | QKO | |
| Z-2971-2020 | Class II | Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526... | Cook Incorporated | FAD | |
| Z-2966-2020 | Class II | AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro... | Randox Laboratories, Limited | JIF | |
| Z-2965-2020 | Class II | AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro... | Randox Laboratories, Limited | JIF | |
| Z-2888-2020 | Class II | Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-2887-2020 | Class II | Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-3016-2020 | Class II | KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S... | Medtronic, Inc. | LRP | |
| Z-0530-2021 | Class II | CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids... | CME America, LLC | FRN | |
| Z-0529-2021 | Class II | CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of... | CME America, LLC | FRN | |
| Z-0528-2021 | Class II | CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids... | CME America, LLC | FRN | |
| Z-0527-2021 | Class II | CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications or fluids... | CME America, LLC | FRN | |
| Z-0526-2021 | Class II | CME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medications or fluids... | CME America, LLC | FRN | |
| Z-0525-2021 | Class II | CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids... | CME America, LLC | FRN | |
| Z-2899-2020 | Class II | RayCare, device is stand-alone software - Product Usage: used to support workflows and... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2969-2020 | Class II | AVANOS MIC-KEY SF Gastrostomy Feeding Tube | Halyard Health | KNT | |
| Z-2988-2020 | Class II | Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI... | Corcym Inc. | LWR | |
| Z-2987-2020 | Class II | Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI... | Corcym Inc. | LWR | |
| Z-2986-2020 | Class II | Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI... | Corcym Inc. | LWR | |
| Z-2985-2020 | Class II | Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE, UDI... | Corcym Inc. | LWR | |
| Z-2984-2020 | Class II | Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI... | Corcym Inc. | LWR | |
| Z-2919-2020 | Class II | PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s glove is a... | Medtronic, Inc. | KGO | |
| Z-2918-2020 | Class II | PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a... | Medtronic, Inc. | KGO | |
| Z-2917-2020 | Class II | PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s glove is a... | Medtronic, Inc. | KGO | |
| Z-2916-2020 | Class II | PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a... | Medtronic, Inc. | KGO | |
| Z-2915-2020 | Class II | PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s glove is a... | Medtronic, Inc. | KGO | |
| Z-2914-2020 | Class II | PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s glove is a... | Medtronic, Inc. | KGO | |
| Z-2913-2020 | Class II | PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a... | Medtronic, Inc. | KGO | |
| Z-2912-2020 | Class II | PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a... | Medtronic, Inc. | KGO | |
| Z-3054-2020 | Class II | Control, Calibrator Verified, Triage BNP, Model ALR88755 | MEDLINE INDUSTRIES, LP - Northfield | JJY | |
| Z-2797-2020 | Class II | Screw Removal Case Assembly, Part Number 1985BASE - Product Usage: The Wright Medical... | Wright Medical Technology Inc | LRO | |
| Z-2889-2020 | Class II | BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack | Becton Dickinson & Co | FMI | |
| Z-2796-2020 | Class II | Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware... | Wright Medical Technology Inc | LRO | |
| Z-3024-2020 | Class II | JINYINSHAN, KN95 PROTECTIVE MASK P1, 20 pieces | Office Depot Inc | NZJ |