Browse Device Recalls
225 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 225 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 225 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 7, 2016 | TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Onl... | DeRoyal received complaints of mold on Tennis Elbow Straps. | Class II | DeRoyal Industries Inc |
| Aug 11, 2016 | DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surg... | The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe ... | Class II | DeRoyal Industries Inc |
| Aug 11, 2016 | Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom s... | The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe ... | Class II | DeRoyal Industries Inc |
| 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 |
| Sep 10, 2015 | DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7... | These custom sterile surgical kits contain the component, ECOLAB ORS Fluid Warming and Slush Drap... | Class II | DeRoyal Industries Inc |
| Aug 31, 2015 | DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Sol... | Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot... | Class II | DeRoyal Industries Inc |
| Aug 31, 2015 | DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (T... | Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot... | Class II | DeRoyal Industries Inc |
| Apr 27, 2015 | Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ... | Surgical kits contain Medtronic Covidien Devon(TM) Light Gloves which were recalled for splits or... | Class II | DeRoyal Industries Inc |
| Apr 17, 2015 | DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Produ... | The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use. | Class II | DeRoyal Industries Inc |
| Aug 22, 2014 | DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, N... | These lots of suction canisters and lids have an insufficient seal under low or intermittent suct... | Class II | DeRoyal Industries Inc |
| Aug 22, 2014 | Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc,... | These lots of suction canisters and lids have an insufficient seal under low or intermittent suct... | Class II | DeRoyal Industries Inc |
| Jun 4, 2014 | DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by... | The firm distributed surgical kits which contained Irrigation Sets which were subsequently recall... | Class II | DeRoyal Industries Inc |
| Jun 4, 2014 | DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: ... | The firm distributed surgical kits which contained Irrigation Sets which were subsequently recall... | Class II | DeRoyal Industries Inc |
| Feb 21, 2014 | DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product... | Moldy smell in product | Class II | DeRoyal Industries Inc |
| Jan 16, 2014 | DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Onl... | Three lots of circumcision clamps were manufactured out of specification and as a result may not ... | Class II | DeRoyal Industries Inc |
| Sep 17, 2013 | DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, R... | The unit displays an error code of hose kinking when no hose kink is present; the unit fails to m... | Class II | DeRoyal Industries Inc |
| Sep 17, 2013 | DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Stra... | The unit displays an error code of hose kinking when no hose kink is present; the unit fails to m... | Class II | DeRoyal Industries Inc |
| Sep 17, 2013 | DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS... | The unit displays an error code of hose kinking when no hose kink is present; the unit fails to m... | Class II | DeRoyal Industries Inc |
| Sep 17, 2013 | DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps N... | The unit displays an error code of hose kinking when no hose kink is present; the unit fails to m... | Class II | DeRoyal Industries Inc |
| Sep 17, 2013 | DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, ... | The unit displays an error code of hose kinking when no hose kink is present; the unit fails to m... | Class II | DeRoyal Industries Inc |
| Sep 17, 2013 | Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoya... | The unit displays an error code of hose kinking when no hose kink is present; the unit fails to m... | Class II | DeRoyal Industries Inc |
| Aug 12, 2013 | DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoy... | One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable p... | Class II | DeRoyal Industries Inc |
| Jul 15, 2013 | DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparo... | DeRoyal Industries is recalling their product Insufflation Tubing Sets due to materials incompati... | Class II | DeRoyal Industries Inc |
| May 30, 2013 | GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE ... | DeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem wi... | Class II | DeRoyal Industries Inc |
| Jun 16, 2012 | Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.0... | Surgical kits and trays contain Stryker Hytrel Togas which were recalled because the clear tape, ... | Class II | DeRoyal Industries 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.