Browse Device Recalls
5,428 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,428 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 5,428 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 12, 2017 | Art-Line Surgery Pack-LF, STERILE, 40 packs each per case. | Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit com... | Class II | Medline Industries, Inc. |
| Apr 10, 2017 | CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit an... | The current secondary packaging, a box, incorrectly states that the product is latex free. The pr... | Class II | CooperSurgical, Inc. |
| Apr 6, 2017 | 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack... | Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were ... | Class II | Amendia, Inc |
| Apr 5, 2017 | The JETSTREAM is a rotational atherectomy catheter system designed for use in... | Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lo... | Class II | Boston Scientific Corporation |
| Apr 4, 2017 | "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitatio... | Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Pro... | Class II | Helena Laboratories, Inc. |
| Mar 30, 2017 | RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, STERILE R... | The stability data does not support the product labeled with a 10-year shelf life. | Class II | Smith & Nephew, Inc. |
| Mar 30, 2017 | RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, STERILE R... | The stability data does not support the product labeled with a 10-year shelf life. | Class II | Smith & Nephew, Inc. |
| Mar 30, 2017 | RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1) | The stability data does not support the product labeled with a 10-year shelf life. | Class II | Smith & Nephew, Inc. |
| Mar 30, 2017 | RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QT... | The stability data does not support the product labeled with a 10-year shelf life. | Class II | Smith & Nephew, Inc. |
| Mar 30, 2017 | RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, STERILE R, QT... | The stability data does not support the product labeled with a 10-year shelf life. | Class II | Smith & Nephew, Inc. |
| Mar 30, 2017 | RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, STERILE R, QT... | The stability data does not support the product labeled with a 10-year shelf life. | Class II | Smith & Nephew, Inc. |
| Mar 30, 2017 | RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QT... | The stability data does not support the product labeled with a 10-year shelf life. | Class II | Smith & Nephew, Inc. |
| Mar 30, 2017 | RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY... | The stability data does not support the product labeled with a 10-year shelf life. | Class II | Smith & Nephew, Inc. |
| Mar 30, 2017 | RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1) | The stability data does not support the product labeled with a 10-year shelf life. | Class II | Smith & Nephew, Inc. |
| Mar 30, 2017 | RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1) | The stability data does not support the product labeled with a 10-year shelf life. | Class II | Smith & Nephew, Inc. |
| Mar 30, 2017 | RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY... | The stability data does not support the product labeled with a 10-year shelf life. | Class II | Smith & Nephew, Inc. |
| Mar 30, 2017 | RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1) | The stability data does not support the product labeled with a 10-year shelf life. | Class II | Smith & Nephew, Inc. |
| Mar 24, 2017 | WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, ... | Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visi... | Class II | Teleflex Medical |
| Mar 15, 2017 | Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hemat... | Avid Medical Inc has received a complaint was received from an end-user indicating the vacutainer... | Class II | Avid Medical, Inc. |
| Mar 10, 2017 | Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a ... | Product shipped proximate to or past the expiration date listed on the product label. | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 9, 2017 | SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, ... | Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural ru... | Class II | C.R. Bard, Inc. |
| Mar 9, 2017 | D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Ort... | The expiration dates on the labeling are incorrect, the actual expiration dates are before the da... | Class II | Smith & Nephew, Inc. |
| Mar 9, 2017 | D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic | The expiration dates on the labeling are incorrect, the actual expiration dates are before the da... | Class II | Smith & Nephew, Inc. |
| Mar 9, 2017 | Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R,... | The expiration dates on the labeling are incorrect, the actual expiration dates are before the da... | Class II | Smith & Nephew, Inc. |
| Mar 9, 2017 | D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: ... | The expiration dates on the labeling are incorrect, the actual expiration dates are before the da... | Class II | Smith & Nephew, Inc. |
| Mar 8, 2017 | BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within ... | A single lot of product that potentially has a single part within the lot that does not match the... | Class II | Biomet 3i, LLC |
| Mar 3, 2017 | It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg).... | Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect s... | Class II | Verathon Inc |
| Mar 3, 2017 | The CG+ Arrow PIC Catheters permit venous access to the central circulation t... | Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithro... | Class II | Arrow International Inc |
| Mar 3, 2017 | ImplantDirect, Dental implants intended for use in partially and fully edentu... | The main vial label lists the incorrect part number, but the cap label is correct. | Class II | Implant Direct Sybron Manufacturing, LLC |
| Mar 2, 2017 | KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK... | Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. | Class III | Microbiologics Inc |
| Mar 2, 2017 | LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO... | Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. | Class III | Microbiologics Inc |
| Feb 28, 2017 | Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages c... | For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error... | Class II | ConMed Corporation |
| Feb 28, 2017 | Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to s... | The device did not have Revolve Stereo Probe labeling, no product code indicating the size and le... | Class II | Devicor Medical Products Inc |
| Feb 28, 2017 | Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages c... | For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error... | Class II | ConMed Corporation |
| Feb 28, 2017 | Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages c... | For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error... | Class II | ConMed Corporation |
| Feb 28, 2017 | Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages c... | For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error... | Class II | ConMed Corporation |
| Feb 28, 2017 | HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE,... | For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error... | Class II | ConMed Corporation |
| Feb 23, 2017 | 9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The ... | The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states ... | Class II | Medical Components, Inc dba MedComp |
| Feb 23, 2017 | Ziehm Imaging solo FD Mobile Fluoroscopic C-arm | During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel wa... | Class II | Ziehm Imaging Inc |
| Feb 22, 2017 | The Medtronic StrataMR adjustable valves and shunts are designed to provide c... | Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the Strata... | Class I | Medtronic Neurosurgery |
| Feb 21, 2017 | MicroAire K-Wires | Mislabeling on three lots of K-Wires. The incorrect product description " dual trocar" instead of... | Class II | MicroAire Surgical Instruments, LLC |
| Feb 20, 2017 | Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: ... | Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads du... | Class II | Terumo Cardiovascular Systems Corporation |
| Feb 20, 2017 | Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage:... | Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads du... | Class II | Terumo Cardiovascular Systems Corporation |
| Feb 16, 2017 | MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1... | Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 1... | Class II | Crossroads Extremity Systems Llc |
| Feb 13, 2017 | Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack I... | Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack... | Class II | Beckman Coulter Inc. |
| Feb 9, 2017 | Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, ... | Smiths Medical became aware that one lot of the Bivona¿ 3.5mm TTS Cuffed Pediatric tracheostomy ... | Class II | Smiths Medical ASD Inc. |
| Feb 8, 2017 | AIA-PACK TgAb CONTROL SET | The label contains two different methodologies. Quality Control values for non-FDA approved metho... | Class III | Tosoh Bioscience, Inc. |
| Feb 8, 2017 | AIA-PACK TPOAb CONTROL SET | The label contains two different methodologies. Quality Control values for non-FDA approved metho... | Class III | Tosoh Bioscience, Inc. |
| Feb 7, 2017 | LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51 | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | LeMaitre Vascular, Inc. |
| Feb 7, 2017 | LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (pap... | The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch | Class II | LeMaitre Vascular, 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.