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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.