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Browse Device Recalls

42 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 42 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 42 FDA device recalls.

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DateProductReasonClassFirm
Feb 11, 2015 Medical Device Exchange X-SAW BLADE; Pouch, Tyvek/Mylar, Sterile, Single Us... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange PhysioMesh Flexible Composite Mesh 10cm x 15cm; Pou... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange FEMORAL CANAL TIP; Pouch, Tyvek/Mylar, Sterile, Sin... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - GIA Auto Suture Loading Unit w/ DST Series Techno... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange BAG, SPECIMEN RETRIEVER ENDO; Pouch, Tyvek/Mylar, S... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, S... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 11mm; Pouc... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange Surgical Gown - Flyte Hood Pouch, Tyvek/Mylar, Steri... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange Aerosizer Stent Sizing Device; Pouch, Tyvek/Mylar, ... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Silicone Round Drain; Pouch, Tyvek/Mylar, Sterile... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Versaport Bladeless Trocar w/ Fixation Cannula 5m... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM; Pouch, Tyvek/Mylar,... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5m... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - GelPort Laparoscopic System; Pouch, Tyvek/Mylar, ... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange 6.0mm Round Fluted Bur Soft Touch; Pouch, Tyvek/Myl... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange PhysioMesh Flexible Composite Mesh 15 x 15cm; Pouch... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange 12x40 Airway Stent System; Pouch, Tyvek/Mylar, Ster... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Trocar VersaPort Plus V2; 5mm -11mm; Pouch, Tyvek... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single ... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - 5.5mm BioComposite Corkscrew FT, Vented Suture An... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange FIBERWIRE SUTURE SCISSOR; Pouch, Tyvek/Mylar, Steri... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; Pouch, Tyvek/Mylar, Steri... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange Round Fluted Bur Aggressive; 4.0mm; Pouch, Tyvek/My... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 12mm; Pouc... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange Angio-Seal VIP Platform/Vascular Closure Device 6F; ... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm; Pouch, Tyvek/My... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Auto Suture Endo Universal 65¿¿ 4mm; Pouch, Tyvek... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire; Pouch, Ty... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange 10MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single ... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange TAUT Intraducer Peritoneal Catheter 2mm x 1.6mm x 7.... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange 10x40 Airway Stent System; Pouch, Tyvek/Mylar, Ster... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange 3.5mm Threaded Cerclage Pin; Pouch, Tyvek/Mylar, St... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Mayfield Disposable Skull Pin; Pouch, Tyvek/Mylar... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Endo Catch 10mm; Pouch, Tyvek/Mylar, Sterile, Sin... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange Insufflation Needle; Pouch, Tyvek/Mylar, Sterile, S... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange Round Diamond Bur Extra Coarse; 3.0mm; Pouch, Tyvek... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange Wire (sternotomy wire); Pouch, Tyvek/Mylar, Sterile... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation Device; P... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, ... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange -Suction Coagulator; Pouch, Tyvek/Mylar, Sterile, S... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A; Pouch... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange PT WIRE 300; Pouch, Tyvek/Mylar, Sterile, Single Us... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp

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.