Browse Device Recalls
3,191 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,191 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 3,191 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 22, 2018 | AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCRE... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Num... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Numb... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part N... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING S... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING ... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Nu... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| May 18, 2018 | OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product C... | The Internal packaging, the pouch and patient labels are improperly labeled. | Class II | OMNIlife science Inc. |
| May 16, 2018 | G-PIN 2.8BL 3.2PL 60CM 2PK; 467265 Intended to be used as a guide pin for... | The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... | Class II | Zimmer Biomet, Inc. |
| May 16, 2018 | 3.2MM X 510MM COCR THD TIP; 14-443053 Intended to be used as a guide pin ... | The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... | Class II | Zimmer Biomet, Inc. |
| May 16, 2018 | BALL TIP GUIDE WIRE 2.0MMX60CM; 469020 Intended to be used as a guide pin... | The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... | Class II | Zimmer Biomet, Inc. |
| May 16, 2018 | BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin... | The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... | Class II | Zimmer Biomet, Inc. |
| May 16, 2018 | DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin... | The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... | Class II | Zimmer Biomet, Inc. |
| May 16, 2018 | BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin ... | The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... | Class II | Zimmer Biomet, Inc. |
| May 16, 2018 | DRILL PT GUIDE WIRE 2MM X 60CM; 469320 Intended to be used as a guide pin... | The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... | Class II | Zimmer Biomet, Inc. |
| May 16, 2018 | GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide ... | The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... | Class II | Zimmer Biomet, Inc. |
| May 16, 2018 | RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for... | The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... | Class II | Zimmer Biomet, Inc. |
| May 16, 2018 | BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin... | The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... | Class II | Zimmer Biomet, Inc. |
| May 16, 2018 | 3.2MM X 560MM COCR THD TIP; 14-441053 Intended to be used as a guide pin ... | The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... | Class II | Zimmer Biomet, Inc. |
| May 16, 2018 | G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL DRIVING GUIDE 4.4MM X 80CM; 467220 ... | The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... | Class II | Zimmer Biomet, Inc. |
| May 16, 2018 | G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 Intended to be used as a guide pin for... | The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... | Class II | Zimmer Biomet, Inc. |
| May 10, 2018 | Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium. | It has been determined that the fill port tube seal integrity was compromised during the manufact... | Class II | Life Technologies, Corp. |
| May 10, 2018 | Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model ... | It has been determined that the fill port tube seal integrity was compromised during the manufact... | Class II | Life Technologies, Corp. |
| May 10, 2018 | Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model ... | It has been determined that the fill port tube seal integrity was compromised during the manufact... | Class II | Life Technologies, Corp. |
| May 10, 2018 | Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numb... | It has been determined that the fill port tube seal integrity was compromised during the manufact... | Class II | Life Technologies, Corp. |
| May 10, 2018 | Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 119... | It has been determined that the fill port tube seal integrity was compromised during the manufact... | Class II | Life Technologies, Corp. |
| May 10, 2018 | GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and c... | It has been determined that the fill port tube seal integrity was compromised during the manufact... | Class II | Life Technologies, Corp. |
| May 10, 2018 | Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage... | Hyalomatrix products are susceptible to degradation as a result of the decomposition of PVC in th... | Class II | Anika Therapeutics, Inc. |
| May 7, 2018 | PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746 | The needle associated with certain suture product codes has the potential to perforate the packag... | Class II | Ethicon, Inc. |
| May 7, 2018 | PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879 | The needle associated with certain suture product codes has the potential to perforate the packag... | Class II | Ethicon, Inc. |
| May 7, 2018 | PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647 | The needle associated with certain suture product codes has the potential to perforate the packag... | Class II | Ethicon, Inc. |
| May 7, 2018 | PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981 | The needle associated with certain suture product codes has the potential to perforate the packag... | Class II | Ethicon, Inc. |
| May 7, 2018 | PRONOVA SUTURE BLUE 122CM M1.5, D10189 | The needle associated with certain suture product codes has the potential to perforate the packag... | Class II | Ethicon, Inc. |
| May 7, 2018 | PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748 | The needle associated with certain suture product codes has the potential to perforate the packag... | Class II | Ethicon, Inc. |
| May 7, 2018 | PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662 | The needle associated with certain suture product codes has the potential to perforate the packag... | Class II | Ethicon, Inc. |
| May 7, 2018 | PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688 | The needle associated with certain suture product codes has the potential to perforate the packag... | Class II | Ethicon, Inc. |
| May 7, 2018 | PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844 | The needle associated with certain suture product codes has the potential to perforate the packag... | Class II | Ethicon, Inc. |
| May 7, 2018 | PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416 | The needle associated with certain suture product codes has the potential to perforate the packag... | Class II | Ethicon, Inc. |
| May 7, 2018 | PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988 | The needle associated with certain suture product codes has the potential to perforate the packag... | Class II | Ethicon, Inc. |
| May 7, 2018 | PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768 | The needle associated with certain suture product codes has the potential to perforate the packag... | Class II | Ethicon, Inc. |
| May 7, 2018 | PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995 | The needle associated with certain suture product codes has the potential to perforate the packag... | Class II | Ethicon, Inc. |
| May 7, 2018 | PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881 | The needle associated with certain suture product codes has the potential to perforate the packag... | Class II | Ethicon, Inc. |
| May 7, 2018 | PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292 | The needle associated with certain suture product codes has the potential to perforate the packag... | Class II | Ethicon, Inc. |
| May 7, 2018 | PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067 | The needle associated with certain suture product codes has the potential to perforate the packag... | Class II | Ethicon, Inc. |
| May 7, 2018 | PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027 | The needle associated with certain suture product codes has the potential to perforate the packag... | Class II | Ethicon, Inc. |
| May 7, 2018 | PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631 | The needle associated with certain suture product codes has the potential to perforate the packag... | Class II | Ethicon, Inc. |
| May 7, 2018 | PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031 | The needle associated with certain suture product codes has the potential to perforate the packag... | Class II | Ethicon, Inc. |
| May 3, 2018 | Medtronic Clip Gun Magazines are packaged in individually sealed pouches and ... | The packaging sterile barrier does not comply with the applicable packaging standard for terminal... | Class II | Medtronic Neurosurgery |
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.