Browse Device Recalls
2,447 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,447 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 2,447 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 25, 2016 | 31" (79 cm) Appx. 3.4 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip... | ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... | Class II | ICU Medical, Inc. |
| Feb 25, 2016 | 30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoL... | ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... | Class II | ICU Medical, Inc. |
| Feb 25, 2016 | 30" (76 cm) Appx. 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip... | ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... | Class II | ICU Medical, Inc. |
| Feb 25, 2016 | 30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Cham... | ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... | Class II | ICU Medical, Inc. |
| Jan 29, 2016 | Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets includi... | Components of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in sur... | Class II | Biomet, Inc. |
| Jan 11, 2016 | NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM ... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, c... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femo... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained,... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous ... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, pate... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, ... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex ... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, ... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat ... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 7, 2016 | HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, ... | Heartware Ventricular Assist System Battery Cell experiencing premature depletion. | Class I | Heartware, Inc. |
| Dec 23, 2015 | Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power ... | The sterile battery may contain particulates within the sterile package. | Class II | Pro-Dex Inc |
| Dec 23, 2015 | Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS ... | The sterile battery may contain particulates within the sterile package. | Class II | Pro-Dex Inc |
| Dec 14, 2015 | Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; ... | Table Bases may have been assembled incorrectly, missing a retaining ring from the head end assem... | Class II | Mizuho OSI |
| Dec 9, 2015 | Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; ... | Product on the package label did not match what was inside the package. The label was for part... | Class II | Zimmer Biomet, Inc. |
| Dec 2, 2015 | Covidien Endo GIA Ultra Universal Standard Stapler Handle Ref: EGIAUSTND ... | Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag... | Class II | Medtronic |
| Dec 2, 2015 | Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Pr... | Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag... | Class II | Medtronic |
| Dec 2, 2015 | Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for di... | The hardware that holds the VESA plate and the display interface / monitor to the bracket may fai... | Class II | Skytron, Div. The KMW Group, Inc |
| Dec 2, 2015 | Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHOR... | Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag... | Class II | Medtronic |
| Dec 2, 2015 | Label reading in part as: "NexGen System, Complete Knee Solution; Reference N... | Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on th... | Class II | Zimmer Manufacturing B.V. |
| Dec 2, 2015 | Best Practice Kits containing certain production lots of Endo GIA Ultra Unive... | Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag... | Class II | Medtronic |
| Nov 30, 2015 | Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: F... | Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike ad... | Class II | Baxter Healthcare Corp. |
| Nov 30, 2015 | Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.... | Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike ad... | Class II | Baxter Healthcare Corp. |
| Nov 30, 2015 | Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, ... | Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike ad... | Class II | Baxter Healthcare Corp. |
| Nov 20, 2015 | IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS; Material Numbe... | During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate ... | Class II | Boston Scientific Corp |
| Nov 20, 2015 | IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Numbe... | During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate ... | Class II | Boston Scientific Corp |
| Nov 20, 2015 | IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: ... | During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate ... | Class II | Boston Scientific Corp |
| Nov 20, 2015 | IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M00... | During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate ... | Class II | Boston Scientific Corp |
| Nov 19, 2015 | VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access an... | Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricul... | Class II | Cook Inc. |
| Nov 17, 2015 | Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retra... | AAG received a customer complaint that corrosion had been found by a hospitals central sterile s... | Class II | Aesculap, Inc. |
| Nov 17, 2015 | ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in... | The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working pr... | Class III | Collagen Matrix Inc |
| Nov 16, 2015 | ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU | 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 | EDI BZO Uncut Sheet - Cup*, Item No. 160170 | 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 | 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP | 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 Dip Card, Item No. IMD-12MO3 | 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 6 Drugs w/Adul, Item No. PSCupA-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 | DrugSmart 9 Test Cup (BUP), Item No. 60960D | 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 11 Panel w/ Adulterant, Item No. I-DXA-1117-131 | 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 | RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA | 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 Wvd 12 Panel Cup w/Adult., Item No. PSCupA-12M-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 Panel Dip Card, Item No. PSD-12BUP | 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 6 Panel Dip Card w/Adult (AU), Item No. PSDA-6MBAU | 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 AMP/OPI2/COC/THC/BZO Test, Item No. 30520D | 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 10 Test Cup (PCP & OXY), Item No. 61020D | 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 CLIA Waived w/Adulteration, Item No. IMCA-7MT-W | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of t... | Class III | Ameditech 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.