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-0053-2024 | Class II | PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30... | Universal Meditech Inc. | NGE | |
| Z-0052-2024 | Class II | PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips | Universal Meditech Inc. | NGE | |
| Z-0051-2024 | Class II | PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS | Universal Meditech Inc. | ORA | |
| Z-0050-2024 | Class II | To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10 | Universal Meditech Inc. | JHI | |
| Z-0049-2024 | Class II | Am I Pregnant? One Step HCG Pregnancy Test REF 100-17 | Universal Meditech Inc. | LCX | |
| Z-0048-2024 | Class II | DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13 | Universal Meditech Inc. | JHI | |
| Z-0047-2024 | Class II | HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP | Universal Meditech Inc. | CEN | |
| Z-0046-2024 | Class II | HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips | Universal Meditech Inc. | JIN | |
| Z-0045-2024 | Class II | HealthyWiser UriTest" UTI Test Strips REF 900-UTI | Universal Meditech Inc. | NGJ | |
| Z-0044-2024 | Class II | HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10 | Universal Meditech Inc. | JMT | |
| Z-0043-2024 | Class II | One Step Ovulation Test REF 200-01 | Universal Meditech Inc. | NGE | |
| Z-0042-2024 | Class II | One Step Pregnancy Test REF 100-01 | Universal Meditech Inc. | LCX | |
| Z-2094-2023 | Class II | BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe... | CareFusion 303, Inc | BRY | |
| Z-2008-2023 | Class II | Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS | Medtronic, Inc. | JAK | |
| Z-1979-2023 | Class II | Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b)... | Wilson-Cook Medical Inc. | QAU | |
| Z-1978-2023 | Class II | Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b)... | Wilson-Cook Medical Inc. | QAU | |
| Z-2246-2023 | Class II | QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the... | Qiagen | QLT | |
| Z-2245-2023 | Class II | QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing... | Qiagen | QLT | |
| Z-2211-2023 | Class II | Contour next GEN Blood Glucose Monitoring System | Medrad, Inc. | NBW | |
| Z-2092-2023 | Class II | NexGen Precoat Stemmed Tibial Plate Size 5 | Zimmer GmbH | JWH | |
| Z-2401-2023 | Class II | UroPass Ureteral Access Sheaths, 5 pieces/box | OLYMPUS Corporation of the Americas | KNY | |
| Z-2102-2023 | Class II | Beside panel FRU (Field Replacement Units) Kits | GE Healthcare | FMZ | |
| Z-2042-2023 | Class II | DigitalDiagnost C90, Model No. 712034 and 712035 | Philips North America LLC | MQB | |
| Z-2034-2023 | Class I | TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter | GE Healthcare Finland Oy | DPZ | |
| Z-2033-2023 | Class I | TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter | GE Healthcare Finland Oy | DPZ | |
| Z-2032-2023 | Class I | TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor... | GE Healthcare Finland Oy | DPZ | |
| Z-2031-2023 | Class I | TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear | GE Healthcare Finland Oy | DPZ | |
| Z-2030-2023 | Class I | TruSignal Ear Sensor, REF TS-E-D; Oximeter | GE Healthcare Finland Oy | DPZ | |
| Z-2029-2023 | Class I | TruSignal Wrap Sensor, REF TS-W-D; Oximeter | GE Healthcare Finland Oy | DPZ | |
| Z-2028-2023 | Class I | TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter | GE Healthcare Finland Oy | DPZ | |
| Z-2027-2023 | Class I | TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter | GE Healthcare Finland Oy | DPZ | |
| Z-2026-2023 | Class I | TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF... | GE Healthcare Finland Oy | DPZ | |
| Z-2101-2023 | Class II | Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901... | GE Healthcare | FMZ | |
| Z-2100-2023 | Class II | Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b... | GE Healthcare | FMZ | |
| Z-1826-2023 | Class I | ARROW Endurance Extended Dwell Peripheral Catheter System | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-2007-2023 | Class II | NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed | Baxter Healthcare Corporation | FNL | |
| Z-2006-2023 | Class II | Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed | Baxter Healthcare Corporation | FNL | |
| Z-2137-2023 | Class II | MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model... | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-2136-2023 | Class II | MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK... | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-2135-2023 | Class II | MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model... | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-2134-2023 | Class II | MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model... | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-2133-2023 | Class II | MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model... | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-2132-2023 | Class II | MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number... | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-2205-2023 | Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the... | MEDLINE INDUSTRIES, LP - Northfield | OJH | |
| Z-2204-2023 | Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the... | MEDLINE INDUSTRIES, LP - Northfield | JOL | |
| Z-2203-2023 | Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the... | MEDLINE INDUSTRIES, LP - Northfield | PXP | |
| Z-2202-2023 | Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the... | MEDLINE INDUSTRIES, LP - Northfield | OXQ | |
| Z-2201-2023 | Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following... | MEDLINE INDUSTRIES, LP - Northfield | LYU | |
| Z-2200-2023 | Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the... | MEDLINE INDUSTRIES, LP - Northfield | LRS | |
| Z-2199-2023 | Class II | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the... | MEDLINE INDUSTRIES, LP - Northfield | LRP |