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.

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DateProductReasonClassFirm
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.