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-0596-05 | The product is refill heads for battery powered toothbrushes. Spinbrush Pro Medium Refill... | The Procter & Gamble Co./THE GILLETTE Company | JEQ | ||
| Z-0595-05 | The product is refill heads for battery powered toothbrushes. Spinbrush Pro EX Soft... | The Procter & Gamble Co./THE GILLETTE Company | JEQ | ||
| Z-0594-05 | The product is a battery operated toothbrush. Spinbrush Pro Medium battery operated... | The Procter & Gamble Co./THE GILLETTE Company | JEQ | ||
| Z-0593-05 | The product is a battery operated toothbrush. Spinbrush Pro Ex Soft battery operated... | The Procter & Gamble Co./THE GILLETTE Company | JEQ | ||
| Z-0592-05 | The product is refill heads for battery powered toothbrushes. Spinbrush Pro Whitening... | The Procter & Gamble Co./THE GILLETTE Company | JEQ | ||
| Z-0591-05 | The product is refill heads for battery powered toothbrushes. Spinbrush Pro Whitening EX... | The Procter & Gamble Co./THE GILLETTE Company | JEQ | ||
| Z-0590-05 | The product is a battery operated toothbrush. Spinbrush Pro Whitening Medium battery... | The Procter & Gamble Co./THE GILLETTE Company | JEQ | ||
| Z-0589-05 | The product is a battery operated toothbrush. Spinbrush Pro Whitening Ex Soft battery... | The Procter & Gamble Co./THE GILLETTE Company | JEQ | ||
| Z-0576-05 | Access Immunoasay Systems Digoxin Reagent | Siemens Healthcare Diagnostics Inc. | KXT | ||
| Z-0681-05 | Sheridan Sher-I-Bronch Endobronchial Tube for Right Bronchial Intubation; an Rx... | Teleflex Medical | CBI | ||
| Z-0680-05 | Sheridan Sher-I-Bronch Left Endobronchial Tube; an Rx, sterile, sinlge use endobronchial... | Teleflex Medical | CBI | ||
| Z-0126-06 | TC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8. | Plus Orthopedics | JWH | ||
| Z-1551-05 | Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in... | Linvatec Corporation | |||
| Z-1550-05 | Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in... | Linvatec Corporation | JDI | ||
| Z-1549-05 | Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in... | Linvatec Corporation | JDI | ||
| Z-1548-05 | Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in... | Linvatec Corporation | JDI | ||
| Z-1547-05 | Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in... | Linvatec Corporation | JDI | ||
| Z-0768-05 | Circuit-Unilimb, Adult, 1M (40''), Disposable, Clean Non-sterile, Adult Anesthesia... | MMS Sales Corp | CAI | ||
| Z-0767-05 | Coaxial Rebreathing Circuit 1.5 M and 2 M, single use, Part nubers T61500 (1.5 M) and... | MMS Sales Corp | CAI | ||
| Z-0766-05 | Circuit-Nexus, Adult, single use, Part Numbers: N7A110CG06, N4A100CE06, C4N0121000... | MMS Sales Corp | CAI | ||
| Z-0765-05 | Circuit- Matching Kit, 40'' Adult, 3L LPF, single use, Part Numbers RP640F0D0 and... | MMS Sales Corp | CAI | ||
| Z-0764-05 | Portex Adult Single Limb Anesthesia Breathing Circuit, single use, Part Numbers: 386000... | MMS Sales Corp | CAI | ||
| Z-0763-05 | Meridian Nexus- Pediatric, single use Part Numbers 60211-1304042, 60111-1, 60111-1MN... | MMS Sales Corp | CAI | ||
| Z-0762-05 | Unilimb Circuit 40'' Bulk, single use Part Number 225-4400-300. Manufactured for MMS... | MMS Sales Corp | CAI | ||
| Z-0761-05 | Circuit-Unilimb, Pediatric, 1M (40''), Disposable, Clean Non-Sterile, Pediatric... | MMS Sales Corp | CAI | ||
| Z-0760-05 | Meridian Nexus, single use. Part Numbers: C4N00D001, 15867, 15880, 15880-30, 12000-1... | MMS Sales Corp | CAI | ||
| Z-0064-06 | Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime... | Boston Scientific Corporation | DRF | ||
| Z-0302-06 | Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040. | Abbott Medical | BTO | ||
| Z-0852-05 | Arrow Continuous Nerve Block Needle, Latex-Free* Rx only*Sterile*Arrow International... | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | ||
| Z-0579-05 | PepGen P-15 Putty (0.5cc) | Dentsply Friadent Ceramed | NPZ | ||
| Z-0695-05 | Easy Access Image Management System with CL.Net. | Philips North America LLC | LMB | ||
| Z-0575-05 | Homedics PowerDent battery powered toothbrush, Model HD-30, individually packaged... | Deals Nothing Over A Dollar | JEQ | ||
| Z-0697-05 | Automatic Cutting Needle, Model: NAC-1820B, Size 18 GA x 20 CM, Lot: xxxx, Single Use... | Remington Medical | KNW | ||
| Z-0651-05 | Roche ULTIMATE 5 HBA1C test kit for use with MIRA analyzers; catalog number 20755656322. | Roche Diagnostics GmbH | LCP | ||
| Z-0574-05 | BioTek brand Automated Microplate Reader; model ELx808, Roche catalog number 03145387001. | Roche Diagnostics GmbH | JJQ | ||
| Z-1408-05 | ITW Dymon Medaphene Plus Country Garden Disinfectant Spray, Pseudomonacidal, Virucidal... | ITW Dymon | LRJ | ||
| Z-1407-05 | ITW Dymon Medaphene Plus Lemon Disinfectant Spray, Pseudomonacidal, Virucidal... | ITW Dymon | |||
| Z-1406-05 | ITW Dymon Medaphene Plus Orange Disinfectant Spray, Pseudomonacidal, Virucidal... | ITW Dymon | LRJ | ||
| Z-1405-05 | ITW Dymon Medaphene Plus Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal... | ITW Dymon | LRJ | ||
| Z-0573-05 | BioTek brand Automated Microplate Reader; model ELx800, Roche catalog number 21045059001. | Roche Diagnostics GmbH | JJQ | ||
| Z-0650-05 | Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322. | Roche Diagnostics GmbH | LCP | ||
| Z-0649-05 | Roche COBAS INTEGRA HBA1c Kits for use with COBAS INTEGRA 400, 400+, 700 and 800... | Roche Diagnostics GmbH | LCP | ||
| Z-0639-05 | Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075 | Boston Scientific Corporation | MTD | ||
| Z-0638-05 | Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668 | Diasorin Inc. | MRG | ||
| Z-0641-05 | Heartsine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003. Serial... | HeartSine Technologies Ltd | MKJ | ||
| Z-0637-05 | LIAISON 25 OH Vitamin D Assay, Manufacturer part # 310900, Lot # 114439E. | Diasorin Inc. | MRG | ||
| Z-0983-05 | TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV... | Roche Molecular Systems Inc | MVU | ||
| Z-0565-05 | Zimmer Orthopaedic Surgical Products, Disposable Cuff, Single Port, Double Bladder Cuff... | Zimmer Surgical SA | KCY | ||
| Z-0564-05 | Zimmer Orthopaedic Surgical Products, Disposable Cuff, Dual Port, Double Bladder Cuff... | Zimmer Surgical SA | KCY | ||
| Z-0682-05 | Tomoscan | Philips North America LLC | KPS |
