Browse Device Recalls
2,055 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,055 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 2,055 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 9, 2019 | Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invas... | The metal cannula are potentially too loose and may become loose when applying the filing material. | Class II | Voco GmbH |
| Jul 3, 2019 | SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic di... | Error in the default configuration which could lead to the incorrect display of patient master data. | Class II | Heidelberg Engineering GmbH |
| Jul 1, 2019 | Universal Sexual Health Testing Kit | A supplier informed PrivaPath Diagnostics that there is a potential for damaged tubes which could... | Class II | Privapath Diagnostics Ltd |
| Jun 28, 2019 | Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An intro... | 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in co... | Class II | Degania Silicone, Ltd. |
| Jun 28, 2019 | Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Healt... | 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in co... | Class II | Degania Silicone, Ltd. |
| Jun 28, 2019 | Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Healt... | 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in co... | Class II | Degania Silicone, Ltd. |
| Jun 28, 2019 | Workstation, G2, Configured (P/N 000-0241) | Apple has determined that, in a limited number of older generation 15-inch MacBook Pro Units, the... | Class II | Intellijoint Surgical, Inc. |
| Jun 28, 2019 | Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar ... | 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in co... | Class II | Degania Silicone, Ltd. |
| Jun 28, 2019 | Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN:... | 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in co... | Class II | Degania Silicone, Ltd. |
| Jun 28, 2019 | Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 ... | 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in co... | Class II | Degania Silicone, Ltd. |
| Jun 28, 2019 | Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar C... | 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in co... | Class II | Degania Silicone, Ltd. |
| Jun 28, 2019 | Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar C... | 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in co... | Class II | Degania Silicone, Ltd. |
| Jun 27, 2019 | AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product ... | The exposed area of fluo exams possibly does not match the active area of the detector within spe... | Class II | Agfa N.V. |
| Jun 27, 2019 | Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PE... | It has been determined that some Pedicle system screw identified as 45mm long have an actual len... | Class II | Medicrea International |
| Jun 24, 2019 | RX Imola, Model Nos. RX4900 | There was a report of a malfunction with the sensor which resulted in an increase of temperature ... | Class II | Randox Laboratories, Limited |
| Jun 24, 2019 | RX Daytona, Model Nos. RX4040 and RX4041 | There was a report of a malfunction with the sensor which resulted in an increase of temperature ... | Class II | Randox Laboratories, Limited |
| Jun 19, 2019 | Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009 | It has been determined that the wheels on the baby scale cart can unexpectedly loosen and in the ... | Class II | Seca |
| Jun 11, 2019 | Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This pr... | The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate a... | Class II | Randox Laboratories, Limited |
| Jun 10, 2019 | Assayed Bovine Multi-Sera Level 1, Model No. AL1027 | The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generat... | Class III | Randox Laboratories, Limited |
| Jun 10, 2019 | Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usa... | Abbott has identified an issue with all on market versions (v2.6.0 and v2.6.1) of Alinity ci seri... | Class II | Abbott Gmbh & Co. KG |
| Jun 6, 2019 | DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone... | Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva s... | Class II | DRG Instruments GmbH |
| May 30, 2019 | Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P | Surface micro/nano topography on some of the implants contained within this lot may not be consi... | Class II | Paltop Advanced Dental Solutions Ltd |
| May 29, 2019 | Quantum Pump Console | Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut d... | Class I | Spectrum Medical Ltd. |
| May 29, 2019 | SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedu... | Handle could jam with the Driver due to the detachment of an internal Connector Ring. | Class II | Pega Medical Inc. |
| May 23, 2019 | DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug ... | The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S.... | Class II | Leventon S. A. U. |
| May 21, 2019 | DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human ... | Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results wh... | Class II | DRG Instruments GmbH |
| May 21, 2019 | The Alinity ci-series System Control Modules which are configured with Alinit... | All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrate... | Class II | Abbott Gmbh & Co. KG |
| May 10, 2019 | EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is in... | Potential for reporting low assay results | Class II | Phadia Ab |
| May 2, 2019 | SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for conti... | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte be... | Class II | SenTec AG |
| May 2, 2019 | SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is ind... | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte be... | Class II | SenTec AG |
| May 2, 2019 | SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - ... | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte be... | Class II | SenTec AG |
| May 2, 2019 | SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated fo... | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte be... | Class II | SenTec AG |
| May 2, 2019 | SenTec Standard Starter Set with and without Service Gas (2 changers each) - ... | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte be... | Class II | SenTec AG |
| Apr 30, 2019 | Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1 | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Apr 30, 2019 | Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1 | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Apr 26, 2019 | Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D... | There is an error in the chromomap on the package insert. | Class III | Cytocell Ltd. |
| Apr 25, 2019 | C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (0... | A reagent in C reactive protein kits is not performing to specification and samples with known co... | Class II | The Binding Site Group, Ltd. |
| Apr 8, 2019 | Drill, cannulated, 4x150mm, AO, Item Number 502015403 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015124 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, 2.7x125mm, AO, Item Number 502015217 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, cannulated, 2.5x95mm, round shaft, Item Number ST502015620 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill for 3.5mm screw, 2.5x125mm, stryker, Item Number 502015218 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill for 2.7mm screw, 2x100mm, AO, Item Number 502015208 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill for 2.7mm screw, 2x120mm, AO, Item Number ST502015212 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | V-TEK", standard-countersink, cannulated, round shaft, Item Number 28.66.110 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, AO, Item Number 502015636 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, 3.2x145mm, AO, Item Number 502015650 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | CBS high, countersink, cannulated, AO, Item Number ST503004542 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | CBS high, countersink, cannulated, AO, Item Number 503004542 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.