Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 27, 2017 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF T... | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... | Class II | SPINEART SA |
| Nov 27, 2017 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF ... | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... | Class II | SPINEART SA |
| Nov 27, 2017 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF T... | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... | Class II | SPINEART SA |
| Nov 27, 2017 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF T... | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... | Class II | SPINEART SA |
| Nov 27, 2017 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF T... | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... | Class II | SPINEART SA |
| Nov 27, 2017 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF T... | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... | Class II | SPINEART SA |
| Nov 24, 2017 | U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303... | UOC received a customer compliant report from our distributor on October 31, 2017 which stated t... | Class II | United Orthopedic Corporation |
| Nov 24, 2017 | U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Cat... | UOC received a customer compliant report from our distributor on October 31, 2017 which stated t... | Class II | United Orthopedic Corporation |
| Nov 22, 2017 | ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use ... | An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number ... | Class II | Atrium Medical Corporation |
| Nov 22, 2017 | 8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyuretha... | The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked ... | Class II | Medical Components, Inc dba MedComp |
| Nov 22, 2017 | CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 100085... | Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The la... | Class II | Smiths Medical ASD Inc. |
| Nov 21, 2017 | OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11... | The device software versions have an anomaly which may produce an erroneous marking for the quali... | Class II | Oculus Optikgeraete GMBH |
| Nov 17, 2017 | StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER ... | Routine bioburden testing of certain lots were found to have levels higher than internal acceptab... | Class II | Stryker Corporation |
| Nov 17, 2017 | Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. ... | The syringe plunger grippers may fail to automatically close around the syringe plunger press whe... | Class II | CareFusion 303, Inc. |
| Nov 17, 2017 | ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile. | Routine bioburden testing of certain lots were found to have levels higher than internal acceptab... | Class II | Stryker Corporation |
| Nov 17, 2017 | STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the followin... | Routine bioburden testing of certain lots were found to have levels higher than internal acceptab... | Class II | Stryker Corporation |
| Nov 17, 2017 | Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. Th... | The syringe plunger grippers may fail to automatically close around the syringe plunger press whe... | Class II | CareFusion 303, Inc. |
| Nov 17, 2017 | STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Mod... | Routine bioburden testing of certain lots were found to have levels higher than internal acceptab... | Class II | Stryker Corporation |
| Nov 14, 2017 | Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591... | The recalled lots have demonstrated unexpected false positive THC results. | Class II | Alere San Diego, Inc. |
| Nov 10, 2017 | iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Ca... | iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barc... | Class II | Beckman Coulter Inc. |
| Nov 10, 2017 | NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStag... | Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatme... | Class II | NxStage Medical, Inc. |
| Nov 6, 2017 | Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and ... | Stent possibly unable to be fully released from the delivery system. | Class II | Boston Scientific Corporation |
| Nov 6, 2017 | Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be ... | Scalpels lot contains non-sterile products labeled as sterile. | Class II | Southmedic, Inc. |
| Nov 6, 2017 | Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and... | Stent possibly unable to be fully released from the delivery system. | Class II | Boston Scientific Corporation |
| Nov 3, 2017 | Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Inten... | Stent length on the label may not match the length of the stent itself. | Class II | Medtronic Inc. |
| Nov 3, 2017 | Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 m... | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Pac... | Class II | Stryker Neurovascular |
| Nov 3, 2017 | Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 m... | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Pac... | Class II | Stryker Neurovascular |
| Nov 3, 2017 | First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-c... | Affected lots may have exceeded its microbial limits. | Class II | Madison Polymeric Engineering |
| Nov 3, 2017 | Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 m... | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Pac... | Class II | Stryker Neurovascular |
| Nov 2, 2017 | CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres. | Product may have incorrect cation information detailed on the product label. | Class II | Remel Inc |
| Oct 26, 2017 | Arterial Access Tray, introducer catheter; Model: GU-04020 | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... | Class II | Arrow International Inc |
| Oct 26, 2017 | Radial Artery Catheterization Kit; Model: AK-04020-C | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... | Class II | Arrow International Inc |
| Oct 26, 2017 | Radial Artery Catheterization Kit; Model: AK-04120 | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... | Class II | Arrow International Inc |
| Oct 26, 2017 | Radial Artery Catheterization Kit; Model: AK-04018 | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... | Class II | Arrow International Inc |
| Oct 26, 2017 | SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Co... | A portion of Lot 7H02242 outer boxes (market units) of the SUR-FIT Natura Moldable Durahesive Ski... | Class II | ConvaTec, Inc |
| Oct 26, 2017 | Radial Artery Catheterization Kit; Model: AK-04122 | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... | Class II | Arrow International Inc |
| Oct 26, 2017 | Radial Artery Catheterization Kit; Model: AK-04020 | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... | Class II | Arrow International Inc |
| Oct 26, 2017 | Radial Artery Catheterization Kit; Model: AK-04220 | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... | Class II | Arrow International Inc |
| Oct 24, 2017 | Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an ... | Incorrect packaging. In one lot of Argyle Suction Tubing, the pouch may be incorrectly labeled as... | Class II | Medtronic Minimally Invasive Therapies Group |
| Oct 23, 2017 | Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone. | The expiration date provided on the label is incorrect. | Class II | Smith & Nephew, Inc. |
| Oct 20, 2017 | HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx O... | The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, ... | Class II | Terumo BCT, Inc. |
| Oct 20, 2017 | HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice... | The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, ... | Class II | Terumo BCT, Inc. |
| Oct 18, 2017 | Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (... | Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled... | Class II | Bioseal Corporation |
| Oct 17, 2017 | Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL... | Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is ... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Oct 13, 2017 | Newton Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Rosen Curved Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | TFE Coated Curved Newton LLT | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Fixed Core Bentson | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Disposable Reuter Tip Deflecting Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Bentson Plus Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook 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.