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-1836-2023 | Class I | Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170095 | Teleflex Medical | BTR | |
| Z-1835-2023 | Class I | Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170090 | Teleflex Medical | BTR | |
| Z-1834-2023 | Class I | Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085 | Teleflex Medical | BTR | |
| Z-1833-2023 | Class I | Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170080 | Teleflex Medical | BTR | |
| Z-1832-2023 | Class I | Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170075 | Teleflex Medical | BTR | |
| Z-1831-2023 | Class I | Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170070 | Teleflex Medical | BTR | |
| Z-1830-2023 | Class I | Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170065 | Teleflex Medical | BTR | |
| Z-1829-2023 | Class I | Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060 | Teleflex Medical | BTR | |
| Z-1828-2023 | Class I | Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055 | Teleflex Medical | BTR | |
| Z-1827-2023 | Class I | Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050 | Teleflex Medical | BTR | |
| Z-0783-2024 | Class II | EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro... | Phadia AB | MOB | |
| Z-2255-2023 | Class II | NeuMoDx Cartridge-used for extraction, purification, amplification and detection of... | Neumodx Molecular, Inc. | PPM | |
| Z-2210-2023 | Class II | RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory... | Cytocell Limited | MVU | |
| Z-2209-2023 | Class II | RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory... | Cytocell Limited | MVU | |
| Z-2130-2023 | Class II | Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress... | Stryker Medical | FPO | |
| Z-2649-2023 | Class II | Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package... | MEDLINE INDUSTRIES, LP - Northfield | HFX | |
| Z-2085-2023 | Class II | TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3... | Integra LifeSciences Braintree Inc. | FTM | |
| Z-2084-2023 | Class II | Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9... | Integra LifeSciences Braintree Inc. | FTM | |
| Z-2083-2023 | Class II | Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm... | Integra LifeSciences Braintree Inc. | FTM | |
| Z-2082-2023 | Class II | PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm... | Integra LifeSciences Braintree Inc. | KGN | |
| Z-2081-2023 | Class II | PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4... | Integra LifeSciences Braintree Inc. | KGN | |
| Z-2080-2023 | Class II | PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4... | Integra LifeSciences Braintree Inc. | KGN | |
| Z-2079-2023 | Class II | PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1)... | Integra LifeSciences Braintree Inc. | KGN | |
| Z-2078-2023 | Class II | PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm... | Integra LifeSciences Braintree Inc. | KGN | |
| Z-2077-2023 | Class II | PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25... | Integra LifeSciences Braintree Inc. | KGN | |
| Z-2076-2023 | Class II | SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm... | Integra LifeSciences Braintree Inc. | FTM | |
| Z-2075-2023 | Class II | SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm... | Integra LifeSciences Braintree Inc. | FTM | |
| Z-2074-2023 | Class II | SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm... | Integra LifeSciences Braintree Inc. | FTM | |
| Z-2073-2023 | Class II | SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm... | Integra LifeSciences Braintree Inc. | FTM | |
| Z-2072-2023 | Class II | SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm... | Integra LifeSciences Braintree Inc. | FTM | |
| Z-2071-2023 | Class II | SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm... | Integra LifeSciences Braintree Inc. | FTM | |
| Z-2070-2023 | Class II | SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm... | Integra LifeSciences Braintree Inc. | FTM | |
| Z-2069-2023 | Class II | SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0... | Integra LifeSciences Braintree Inc. | FTM | |
| Z-2045-2023 | Class II | wDR 2.2 Mobile Digital Diagnostic X-Ray System | Sedecal S.A. | IZL | |
| Z-1697-2023 | Class II | BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish | Young Dental Manufacturing Co 1, LLC. | LBH | |
| Z-0068-2024 | Class II | OMTMO One Step Ovulation (LH) Test Strips REF 200-07 | Universal Meditech Inc. | NGE | |
| Z-0067-2024 | Class II | DiagnosUS Ovulation Predictor Midstream REF 200-17 | Universal Meditech Inc. | NGE | |
| Z-0066-2024 | Class II | DiagnosUS Pregnancy Test Midstream REF 100-17 | Universal Meditech Inc. | LCX | |
| Z-0065-2024 | Class II | DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27 | Universal Meditech Inc. | JHI | |
| Z-0064-2024 | Class II | DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13 | Universal Meditech Inc. | JHI | |
| Z-0063-2024 | Class II | DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12 | Universal Meditech Inc. | JHI | |
| Z-0062-2024 | Class II | Lem Fertility LH Ovulation Test (Strip) REF 200-07 | Universal Meditech Inc. | NGE | |
| Z-0061-2024 | Class II | Lem Fertility hCG Pregnancy Urine Test REF 100-12 | Universal Meditech Inc. | JHI | |
| Z-0060-2024 | Class II | DiagnosUS One Step FSH Menopausal Test (Strip) REF 210-07 | Universal Meditech Inc. | CGJ | |
| Z-0059-2024 | Class II | DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10 | Universal Meditech Inc. | QKO | |
| Z-0058-2024 | Class II | DiagnosUS One Step LH Ovulation Test Strip REF 200-07 | Universal Meditech Inc. | NGE | |
| Z-0057-2024 | Class II | PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10 | Universal Meditech Inc. | JMT | |
| Z-0056-2024 | Class II | PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE | Universal Meditech Inc. | JIN | |
| Z-0055-2024 | Class II | PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS | Universal Meditech Inc. | LCX | |
| Z-0054-2024 | Class II | PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips | Universal Meditech Inc. | LCX |