Browse Device Recalls

2,522 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,522 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 2,522 FDA device recalls.

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DateProductReasonClassFirm
Nov 16, 2015 ProScreen 10 Panel Dip Card, Item No. PSD-10MOX, PSD-10MOB, PSD-10MMO300 Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... Class III Ameditech Inc
Nov 16, 2015 ProScProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... Class III Ameditech Inc
Nov 16, 2015 DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... Class III Ameditech Inc
Nov 16, 2015 ProScreen 9 Panel Cup w/Adulterants, Item No. PSCUPA-9BO300 Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... Class III Ameditech Inc
Nov 16, 2015 Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... Class III Ameditech Inc
Nov 16, 2015 ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... Class III Ameditech Inc
Nov 16, 2015 iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023 Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... Class III Ameditech Inc
Nov 16, 2015 DrugSmart 11 Test Cup, Item No. 61127D Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... Class III Ameditech Inc
Nov 16, 2015 ProScreen 10 Drug Panel Cassette Test, Item No. PSP-10PPX Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... Class III Ameditech Inc
Nov 16, 2015 1 Step 12 Panel Cup, Item No. NBCA-12M-W Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of ... Class III Ameditech Inc
Nov 16, 2015 BZO Strip Dip Card (300ng/ml)*, Item No. 100170 Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... Class III Ameditech Inc
Nov 16, 2015 iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013 Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... Class III Ameditech Inc
Nov 16, 2015 10-Panel Pipette Drug Screen, Item No. PSP-10M Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... Class III Ameditech Inc
Nov 16, 2015 ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... Class III Ameditech Inc
Nov 16, 2015 Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5 Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... Class III Ameditech Inc
Nov 16, 2015 Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-11OP Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... Class III Ameditech Inc
Nov 16, 2015 ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... Class III Ameditech Inc
Nov 16, 2015 ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... Class III Ameditech Inc
Nov 16, 2015 11 Panel Card (OPI 300) w/Adult, Item No. 71125AA Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... Class III Ameditech Inc
Nov 16, 2015 DrugSmart Cup 10, Item No. 61093D-3C, 61085D, 61015D Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... Class III Ameditech Inc
Nov 8, 2015 Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100... Testing at customer site showed unit Remote Patient Monitoring System MDP2040-0100 in a continuou... Class II Vidco, Inc.
Nov 6, 2015 Destination Renal Guiding Sheath Intended for the introduction of interven... Based on internal investigation and testing that revealed the distal end of certain lots of Terum... Class II Terumo Medical Corporation
Nov 6, 2015 Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable ... Particulates: Complaints of rubber coring from the closure of injection vials. Class II Myco Medical Supplies Inc
Nov 2, 2015 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixat... It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the inco... Class II Synthes (USA) Products LLC
Oct 27, 2015 U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles wer... The firm had received a complaint alleging that a medical professional had difficulty inserting a... Class II Procedure Products, Inc.
Oct 20, 2015 iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Pane... Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class II Ameditech Inc
Oct 14, 2015 Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M,... The following MRx software issue has been identified: MRx model M3535A with software version F.03... Class II Philips Electronics North America Corporation
Oct 14, 2015 HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per bo... DeRoyal manufactured four lots of HNICU-32, Hydro-Temp(R) Neonatal Temperature Skin Sensor incorr... Class II DeRoyal Industries Inc
Oct 7, 2015 Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortme... A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty c... Class II Ivoclar A. G.
Sep 28, 2015 Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile... The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Part number 02.117.41... Class II Synthes (USA) Products LLC
Sep 22, 2015 Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devi... Integra received an Urgent Drug Recall Notice from Hospira Inc. for their 1% Lidocaine HCL Inject... Class II Integra LifeSciences Corp. d.b.a. Integra Pain ...
Sep 17, 2015 Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). ... Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communi... Class II Boston Scientific Corporation
Sep 15, 2015 AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid ba... Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the ... Class II Encore Medical, Lp
Sep 14, 2015 Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates an... Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03.120.001, 03.120... Class II Synthes (USA) Products LLC
Sep 11, 2015 NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne d... When using the NicoletOne v5.94 software, after exiting the impedance check function and returnin... Class II Natus Neurology Inc
Sep 11, 2015 Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder ... Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labe... Class III Acumedia Manufacturers, Inc.
Aug 14, 2015 SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR ... The dimensions of the mating features of the recalled products are out of specification causing t... Class II Limacorporate S.p.A
Aug 14, 2015 SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoul... The dimensions of the mating features of the recalled products are out of specification causing t... Class II Limacorporate S.p.A
Aug 12, 2015 FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter:... The expiration date was incorrectly printed on the pouch/box labels of 19 products that were ship... Class III Abbott Electrophysiology
Aug 6, 2015 Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 5950... SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mec... Class I SynCardia Systems Inc.
Jul 31, 2015 Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. ... Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restr... Class II Edward Lifesciences, Llc
Jul 20, 2015 Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Hea... Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported t... Class II Trilliant Surgical Ltd.
Jul 16, 2015 Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality... Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Vo... Class I Covidien LP (formerly Nellcor Puritan Bennett I...
Jul 15, 2015 EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-... Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate. Class I Medtronic Cardiovascular Surgery-the Heart Valv...
Jul 13, 2015 RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Inte... Electrostatic energy may be stored in Systems that can cause a short-cicuit which, in turn, can g... Class II Sedecal S.A.
Jul 7, 2015 RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 6905920... EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particu... Class II Eizo Corporation
Jul 7, 2015 RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, ... EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particu... Class II Eizo Corporation
Jul 7, 2015 RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD18... EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particu... Class II Eizo Corporation
Jun 30, 2015 PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Pr... Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are ... Class II BIOTRONIK, Inc.
Jun 12, 2015 ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial Arti... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.

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.