Browse Device Recalls
3,096 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,096 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 3,096 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 12, 2013 | Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable S... | Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond... | Class II | Ansell Sandel Medical Industries LLC |
| Oct 18, 2013 | Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Cat... | Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) C... | Class II | Stryker Sustainability Solutions |
| Oct 3, 2013 | STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product cod... | Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not ... | Class III | Advanced Sterilization Products |
| Aug 28, 2013 | Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse ... | The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured. | Class II | Globus Medical, Inc. |
| Aug 12, 2013 | Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed i... | A medical device used in surgical procedures was packaged in a pouch in which a defective seal ma... | Class II | MicroAire Surgical Instruments, LLC |
| Aug 12, 2013 | Steinmann Pin, packed in a clear tube with end caps, tubes packed in a steril... | A medical device used in surgical procedures was packaged in a pouch in which a defective seal ma... | Class II | MicroAire Surgical Instruments, LLC |
| Jul 31, 2013 | "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors ... | The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance ... | Class II | Edwards Lifesciences, LLC |
| Jul 26, 2013 | Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/... | This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... | Class II | ASO, LLC |
| Jul 26, 2013 | Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in... | This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... | Class II | ASO, LLC |
| Jul 26, 2013 | Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 ... | This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... | Class II | ASO, LLC |
| Jul 26, 2013 | Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 i... | This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... | Class II | ASO, LLC |
| Jul 26, 2013 | TopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 i... | This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... | Class II | ASO, LLC |
| Jul 26, 2013 | Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape... | This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... | Class II | ASO, LLC |
| Jul 26, 2013 | HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. S... | This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... | Class II | ASO, LLC |
| Jul 26, 2013 | CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. ... | This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... | Class II | ASO, LLC |
| Jul 26, 2013 | Premier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in.... | This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... | Class II | ASO, LLC |
| Jul 24, 2013 | Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 083104... | Nestle HealthCare Nutrition, Inc. is initiating a recall on some of Compat NG Tubes because they... | Class II | Nestle HealthCare Nutrition |
| Jul 22, 2013 | Contra-Angle Torque Driver Kit For Certain and External Connection Product... | During recent revised sterilization validation testing, the included surgical trays did not meet ... | Class II | Biomet 3i, LLC |
| Jul 22, 2013 | Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usa... | During recent revised sterilization validation testing, the included surgical trays did not meet ... | Class II | Biomet 3i, LLC |
| Jul 22, 2013 | Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in... | During recent revised sterilization validation testing, the included surgical trays did not meet ... | Class II | Biomet 3i, LLC |
| Jul 22, 2013 | Navigator Surgical Kit Product Usage: Molded plastic tray used in holding... | During recent revised sterilization validation testing, the included surgical trays did not meet ... | Class II | Biomet 3i, LLC |
| Jul 22, 2013 | Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray... | During recent revised sterilization validation testing, the included surgical trays did not meet ... | Class II | Biomet 3i, LLC |
| Jul 18, 2013 | Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Late... | Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sa... | Class II | Aspen Surgical Products, Inc. |
| Jun 24, 2013 | SC2316, Distal Femoral Augment with Screw Total knee replacement due to os... | The firm became aware of an incident relating to a breach of sterility in the sterility barrier p... | Class II | Stelkast Co |
| Jun 19, 2013 | VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 m... | Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... | Class II | Zimmer, Inc. |
| Jun 19, 2013 | VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and shor... | Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... | Class II | Zimmer, Inc. |
| Jun 19, 2013 | Free Lock Femoral Hip Fixation System Compression Tube/Plate, different lengt... | Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... | Class II | Zimmer, Inc. |
| Jun 19, 2013 | Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths... | Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... | Class II | Zimmer, Inc. |
| Jun 19, 2013 | VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and shor... | Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... | Class II | Zimmer, Inc. |
| May 31, 2013 | 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUS... | Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the... | Class II | Karl Storz Endoscopy America Inc |
| May 24, 2013 | GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 13071... | lack of sterility assurance | Class II | Gyrus Acmi, Incorporated |
| May 6, 2013 | Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachm... | Product did not reach expected sterility assurance level | Class II | The Anspach Effort, Inc. |
| Apr 30, 2013 | FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray. | American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in re... | Class II | American Optisurgical Inc |
| Apr 8, 2013 | Endopath Electrosurgery Probe Plus II, twelve (12) different devices, includi... | The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in th... | Class II | Ethicon Endo-Surgery Inc |
| Mar 22, 2013 | LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit... | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 22, 2013 | LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit. | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 22, 2013 | LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit. | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 22, 2013 | LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid ... | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 22, 2013 | LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povi... | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 22, 2013 | LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016... | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 22, 2013 | LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Numb... | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 22, 2013 | LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. Fi... | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 18, 2013 | LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 ... | Devices were not sealed correctly during the manufacturing process, and the sterility of these pr... | Class II | LeMaitre Vascular, Inc. |
| Mar 18, 2013 | Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 ... | Devices were not sealed correctly during the manufacturing process, and the sterility of these pr... | Class II | LeMaitre Vascular, Inc. |
| Mar 14, 2013 | Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: T... | Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly seale... | Class II | Edwards Lifesciences, LLC |
| Mar 4, 2013 | Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product... | An internal review of CareFusion's labeling for preoperative skin prep product codes was recently... | Class III | CareFusion 213, LLC |
| Feb 8, 2013 | Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part ... | Possibility that the inner pouch may be compromised. The product is packaged in two pouches - a s... | Class II | Zimmer, Inc. |
| Feb 7, 2013 | Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medi... | Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility. | Class II | Myco Medical Supplies Inc |
| Jan 14, 2013 | BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev ... | The recall was initiated because Breg has determined that some Sterile Polar Pads products manufa... | Class II | Breg Inc |
| Jan 14, 2013 | BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Mode... | The recall was initiated because Breg has determined that some Sterile Polar Pads products manufa... | Class II | Breg 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.