Browse Device Recalls
3,282 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,282 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 3,282 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 12, 2016 | Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral... | Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... | Class II | Exactech, Inc. |
| Apr 12, 2016 | Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabula... | Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... | Class II | Exactech, Inc. |
| Apr 12, 2016 | Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral St... | Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... | Class II | Exactech, Inc. |
| Apr 4, 2016 | Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripher... | Device packaging may not be sealed. | Class II | Stryker Sustainability Solutions |
| Apr 4, 2016 | Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175 | Device packaging may not be sealed. | Class II | Stryker Sustainability Solutions |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. guide, surgical... | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Bit, drill. | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Passer. | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Pin, fixation, ... | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Appliance, fixa... | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Fastener, fixat... | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Plate, fixation... | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Reamer. | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. cannula, surgic... | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Orthopedic manu... | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Arthroscope. | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Screw, fixation... | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Spinal interlam... | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Rod, fixation, ... | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Mar 31, 2016 | Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neu... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Tonsil Sponges 1" Large Ref Number: 50-01 Product Usage: ... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Uniqcot 1/2" x 3" Ref Number: 67-09 Product Usage: Neuro... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Ultracot 30 mm x 70 mm (Glassine) Ref Number: 23-10G Prod... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Ne... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Ray-Cot 1" x 1" Ref Number: 60-12 Product Usage: Neurosu... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Americot Blue 1/2" x 1" Ref Number: 20-05S Product Usage:... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Americot Blue 1/2" x 3" Ref Number: 20-07S Product Usage:... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Americot Blue 3/8" x 3/8" Ref Number: 20-22S Product Usag... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Ultracot 15 mm x 20 mm Ref Number: 23-04 Product Usage: ... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Cotton Balls-Strung 3/8" Ref Number: 30-01 Product Usage:... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Cotton Balls-Non-Strung 1/8" Ref Number: 31-07 Product Us... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Ultracot 15 mm x 20 mm (Glassine) Ref Number: 23-04G Prod... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: ... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Cotton Balls-Strung 1/8" Ref Number: 30-07 Product Usage:... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Delicot X 6 mm x 50 mm Ref Number: 63x06 Product Usage: ... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Ultracot 20 mm x 60 mm Ref Number: 23-09 Product Usage: ... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Delicot 9 mm x 50 mm Ref Number: 63-07 Product Usage: ... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgi... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Telfa 1/2" x 1/2" Ref Number: 80-06 Product Usage: Neu... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Delicot-J 13 mm x 60 mm Ref Number: 63-08J (Japan only) P... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Ray-Cot 1" x 3" Ref Number: 60-13 Product Usage: Neurosu... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Americot Blue 1/8" x 1/8" Ref Number: 20-19S Product Usag... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Ultracot 9 mm x 50 mm (Glassine) Ref Number: 23-07G Prod... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Telfa 1" x 3" Ref Number: 80-13 Product Usage: Neurosu... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Delicot 5 mm x 13 mm Ref Number: 63-02 Product Usage: ... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Ultracot 13 mm x 60 mm Ref Number: 23-08 Product Usage: ... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Americot Blue 3/8" x 3/4" Ref Number: 20-14S Product Usag... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Ultracot 5 mm x 8 mm Ref Number: 23-01 Product Usage: N... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Policot 1/2" x 1.5" Ref Number: 90-08 Product Usage: N... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Delicot-J 15 mm x 20 mm Ref Number: 63-04J (Japan Only) ... | Product packaging defective compromising sterility | Class II | American Surgical Company |
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.