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.

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DateProductReasonClassFirm
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.