Browse Device Recalls
3,264 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,264 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 3,264 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Jun 4, 2013 | Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disp... | Utah Medical Products, Inc. is recalling certain Deltran Disposable Pressure Transducer Kits due ... | Class II | Utah Medical Products, Inc |
| Jun 3, 2013 | Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert O... | Alere initiated this recall of certain lots of the Oral Fluid Drug Screen Device because the spon... | Class II | Alere San Diego, 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 23, 2013 | Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, ... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; si... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; singl... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; sing... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; singl... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO;... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; ... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; sin... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single ... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, E... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single u... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; si... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single us... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; singl... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single us... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 15, 2013 | Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Conta... | A firm's internal investigation led to the discovery of pinholes in the packaging of the products... | Class II | Baxter Healthcare Corp. |
| May 15, 2013 | Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Prod... | A firm's internal investigation led to the discovery of pinholes in the packaging of the products... | Class II | Baxter Healthcare Corp. |
| May 15, 2013 | Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Contai... | A firm's internal investigation led to the discovery of pinholes in the packaging of the products... | Class II | Baxter Healthcare Corp. |
| May 8, 2013 | DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 ... | LifeLiner Stick and Cut Resistant Gloves are being recalled because cases and individual glove pa... | Class III | DePuy Orthopaedics, 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 12, 2013 | Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Colopla... | Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorre... | Class II | Coloplast Manufacturing US, LLC |
| Apr 12, 2013 | BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptiv... | In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiologic... | Class II | Becton Dickinson & Co. |
| Apr 12, 2013 | BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive di... | In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiologic... | Class II | Becton Dickinson & Co. |
| 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 28, 2013 | Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile uri... | Sterile packaging may be compromised. | Class II | Teleflex Medical |
| Mar 26, 2013 | Presource PBDS, General Laparoscopy, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Beaufort Memorial Hospital, Anesthesia Circuit, Kit | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Knee Arthroscopy, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Extremity, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Total Knee, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Major Abdominal, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Total Joint, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Total Hip, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Gyn Laparoscopy Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood L... | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Hand, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Knee Arthroscopy, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Shoulder Arthroscopy, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 26, 2013 | Presource PBDS, Shoulder Procedure, Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain out... | Class I | Cardinal Health, Medical Products & Services |
| Mar 25, 2013 | Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit pe... | Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathal... | Class II | Stryker Howmedica Osteonics Corp. |
| Mar 8, 2013 | Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bra... | Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a p... | Class II | Ormco/Sybronendo |
| Feb 26, 2013 | Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Mod... | Incorrect size was printed on the outer product packaging. | Class II | Cooper Surgical, 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 |
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.