Browse Device Recalls
2,115 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,115 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 2,115 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 21, 2019 | Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage... | The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instr... | Class II | Stryker GmbH |
| Jan 11, 2019 | aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Su... | There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel b... | Class II | AAP Implantate Ag |
| Jan 10, 2019 | 21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is ... | Some of the installed valve-inserts have a diameter smaller than the specification. | Class II | Ottobock Orthopedic Industrie |
| Jan 10, 2019 | AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonad... | hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG con... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Jan 10, 2019 | DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotro... | hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG con... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Jan 10, 2019 | 21Y14 PushValve Product Usage: The PushValves/ MagValves is intended ex... | Some of the installed valve-inserts have a diameter smaller than the specification. | Class II | Ottobock Orthopedic Industrie |
| Jan 10, 2019 | 21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclu... | Some of the installed valve-inserts have a diameter smaller than the specification. | Class II | Ottobock Orthopedic Industrie |
| Jan 10, 2019 | AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonad... | hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG con... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Jan 7, 2019 | AVE 2 Birthing Bed | LINET has recently become aware of a potential safety issue for the AVE 2 Birthing Bed caused by ... | Class II | Linet Spol. S.r.o. |
| Dec 28, 2018 | 16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Produc... | The firm had a report of doctors being unable to pull the obstetric forceps apart. | Class II | Fetzer Medical GmbH & Co. KG |
| Dec 28, 2018 | 12002 / Boss Instruments Ltd. Wrigley Obstetric Forceps, 11" (28cm), Item No.... | The firm had a report of doctors being unable to pull the obstetric forceps apart. | Class II | Fetzer Medical GmbH & Co. KG |
| Dec 28, 2018 | 16600 / Fetzer Surgical Luikart Simpson OB Forceps14" (35.5cm), Item No./Prod... | The firm had a report of doctors being unable to pull the obstetric forceps apart. | Class II | Fetzer Medical GmbH & Co. KG |
| Dec 28, 2018 | 12002 / Boss Instruments Simpson OB Forceps, short model, 13" (33cm), Item No... | The firm had a report of doctors being unable to pull the obstetric forceps apart. | Class II | Fetzer Medical GmbH & Co. KG |
| Dec 26, 2018 | Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only | Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag ... | Class I | WEST PHARMA. SERVICES IL, LTD |
| Dec 26, 2018 | Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only | Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag ... | Class I | WEST PHARMA. SERVICES IL, LTD |
| Dec 26, 2018 | Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only | Adverse events have been reported with the use of oxytocin in conjunction with the product in pre... | Class I | WEST PHARMA. SERVICES IL, LTD |
| Dec 20, 2018 | Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30... | Abbott has identified an issue with the Alinity i Gear Pump Assembly (part number A 30108552 01) ... | Class II | Abbott Gmbh & Co. KG |
| Dec 10, 2018 | Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement... | Product mix up | Class II | Signature Orthopedics Pty Limited |
| Dec 10, 2018 | Genius Knee Cemented Tibial Component Product Usage: Knee replacement com... | Product mix up | Class II | Signature Orthopedics Pty Limited |
| Dec 3, 2018 | Fructosamine Control 1, FR2994 This product is intended for in vitro use ... | The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 ... | Class II | Randox Laboratories Ltd. |
| Dec 3, 2018 | Fructosamine Calibrator, FR2993 This product is intended for in vitro use ... | The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 ... | Class II | Randox Laboratories Ltd. |
| Dec 3, 2018 | Fructosamine Control 3, FR2996 This product is intended for in vitro use ... | The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 ... | Class II | Randox Laboratories Ltd. |
| Nov 30, 2018 | Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 | Philips has discovered through customer complaints and internal testing an intermittent electroni... | Class II | Philips Medical Systems Nederlands |
| Nov 21, 2018 | Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferriti... | Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in so... | Class II | Abbott Ireland Diagnostics Division |
| Nov 7, 2018 | Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stati... | kV/mA lockin not functioning as specified which may result in the patient receiving an increased ... | Class II | Philips Medical Systems Gmbh, DMC |
| Nov 7, 2018 | Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-... | Incorrect packaging; There is a potential that a 1.0 mm carbide blade was packaged in a 0.9 mm ... | Class II | Hager & Meisinger Gmbh |
| Nov 6, 2018 | Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists... | Firm is offering advice to customers experiencing challenges when validating the calibration curv... | Class II | The Binding Site Group, Ltd. |
| Nov 2, 2018 | STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-track... | The firm has detected a potential risk using the command. After releasing the command, the movem... | Class II | Stephanix |
| Nov 1, 2018 | VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qua... | The firm is extending their previous July 2018 recall to include additional product codes. Biased... | Class II | ORTHO-CLINICAL DIAGNOSTICS |
| Nov 1, 2018 | VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in v... | The firm is extending their previous July 2018 recall to include additional product codes. Biased... | Class II | ORTHO-CLINICAL DIAGNOSTICS |
| Nov 1, 2018 | VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro dia... | The firm is extending their previous July 2018 recall to include additional product codes. Biased... | Class II | ORTHO-CLINICAL DIAGNOSTICS |
| Oct 25, 2018 | HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.) | A stray strand of stainless-steel cable may protrude from the heat shrink sleeving on the Balanc... | Class II | The Magstim Company Limited |
| Oct 22, 2018 | NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT... | Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) oc... | Class II | Neusoft Medical Systems Co., Ltd. |
| Oct 22, 2018 | NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-S... | Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) oc... | Class II | Neusoft Medical Systems Co., Ltd. |
| Oct 22, 2018 | NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT ... | Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) oc... | Class II | Neusoft Medical Systems Co., Ltd. |
| Oct 22, 2018 | PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flo... | It is possible that the packaging of the product can be damaged by the prongs on the tube set. | Class II | WOM World of Medicine AG |
| Oct 22, 2018 | ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The ... | Inspection process at the manufacturer found nonwoven material was used in specific lots of produ... | Class II | ARJOHUNTLEIGH POLSKA Sp. z.o.o. |
| Oct 17, 2018 | Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-... | A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack... | Class II | Leoni Fiber Optics GmbH |
| Oct 17, 2018 | Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-... | A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack... | Class II | Leoni Fiber Optics GmbH |
| Oct 17, 2018 | Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-... | A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack... | Class II | Leoni Fiber Optics GmbH |
| Oct 17, 2018 | Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve S... | A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack... | Class II | Leoni Fiber Optics GmbH |
| Oct 17, 2018 | Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Ste... | A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack... | Class II | Leoni Fiber Optics GmbH |
| Oct 16, 2018 | MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PUL... | Devices were distributed despite the Helium-fine leak test results not being within the cochlear ... | Class II | MED-EL Elektromedizinische Gereate, Gmbh |
| Oct 16, 2018 | MED EL Cochlear Implant System, SONATATIi100, sold under the following implan... | Devices were distributed despite the Helium-fine leak test results not being within the cochlear ... | Class II | MED-EL Elektromedizinische Gereate, Gmbh |
| Oct 16, 2018 | MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the follo... | Devices were distributed despite the Helium-fine leak test results not being within the cochlear ... | Class II | MED-EL Elektromedizinische Gereate, Gmbh |
| Oct 9, 2018 | BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2... | This recall has been initiated due to a software defect found in the Guide System software when u... | Class I | Synaptive Medical Inc |
| Oct 8, 2018 | Insulia Diabetes Management Companion | The firm identified an issue with the basal calculator identified on the Android version of the I... | Class II | Voluntis |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM ... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
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.