Browse Device Recalls

740 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 740 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 740 FDA device recalls in TN.

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Date	Product	Reason	Class	Firm
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 27, 2013	GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), R...	The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert...	Class II	Smith & Nephew Inc
Aug 27, 2013	GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), ...	The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert...	Class II	Smith & Nephew Inc
Aug 27, 2013	GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), R...	The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert...	Class II	Smith & Nephew Inc
Aug 27, 2013	GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), R...	The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert...	Class II	Smith & Nephew Inc
Aug 27, 2013	GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), RE...	The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert...	Class II	Smith & Nephew Inc
Aug 27, 2013	GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1...	The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert...	Class II	Smith & Nephew Inc
Aug 12, 2013	T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile ...	One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8...	Class II	Medtronic Sofamor Danek USA 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
Jul 8, 2013	GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM...	The products were produced using the wrong color material, resulting in the devices being red (u...	Class II	Smith & Nephew 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
May 29, 2013	R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: ...	One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and on...	Class II	Smith & Nephew Inc
May 29, 2013	R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: ...	One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and on...	Class II	Smith & Nephew Inc
May 28, 2013	INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA,...	Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu...	Class II	Medtronic Sofamor Danek USA Inc
May 28, 2013	INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, ...	Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu...	Class II	Medtronic Sofamor Danek USA Inc
May 28, 2013	INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek US...	Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu...	Class II	Medtronic Sofamor Danek USA Inc
May 28, 2013	INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, I...	Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu...	Class II	Medtronic Sofamor Danek USA Inc
May 28, 2013	INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA...	Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu...	Class II	Medtronic Sofamor Danek USA Inc
May 28, 2013	INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek ...	Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu...	Class II	Medtronic Sofamor Danek USA Inc
May 28, 2013	INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, I...	Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu...	Class II	Medtronic Sofamor Danek USA Inc
Apr 10, 2013	Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (...	There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use.	Class II	Symmetry Medical/SSI
Mar 6, 2013	TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF ...	One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold...	Class II	Smith & Nephew Inc
Feb 7, 2013	INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAP...	75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm scre...	Class II	Smith & Nephew Inc
Feb 7, 2013	INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAP...	75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm scre...	Class II	Smith & Nephew Inc
Sep 5, 2012	Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers...	There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, Franc...	Class II	Wright Medical Technology Inc
Sep 5, 2012	Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Numbe...	There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, Franc...	Class II	Wright Medical Technology Inc
Sep 5, 2012	Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383...	There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, Franc...	Class II	Wright Medical Technology Inc
Aug 30, 2012	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 1...	Lines on the screw gauge may not placed on the caddy properly which could result in improper meas...	Class II	Medtronic Sofamor Danek USA Inc
Aug 30, 2012	PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 E...	Lines on the screw gauge may not placed on the caddy properly which could result in improper meas...	Class II	Medtronic Sofamor Danek USA Inc
Aug 30, 2012	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-...	Lines on the screw gauge may not placed on the caddy properly which could result in improper meas...	Class II	Medtronic Sofamor Danek USA Inc
Aug 22, 2012	12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL ...	Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.	Class II	Smith & Nephew Inc
Aug 15, 2012	0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL...	One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chl...	Class III	Amsino Medical USA
Aug 15, 2012	0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 m...	One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chl...	Class III	Amsino Medical USA
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
Nov 30, 2009	Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123...	Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead...	Class II	NAImco Inc dba Richmar Inc
Nov 30, 2009	Cloth electrodes with Silver-Carbon construction: P/N 202-9231, Cat No. 400-...	Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead...	Class II	NAImco Inc dba Richmar Inc
Nov 30, 2009	Foam electrodes with Silver-Carbon construction: P/N 202-9271, Cat No. 400-8...	Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead...	Class II	NAImco Inc dba Richmar Inc
Nov 30, 2009	Foam Electrodes with Carbon construction: P/N 201-1261, Cat Nos.: 201-126, 2...	Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead...	Class II	NAImco Inc dba Richmar 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.