Browse Device Recalls
2,522 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,522 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 2,522 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 9, 2019 | Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usag... | An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. | Class II | ConvaTec, Inc |
| Jan 3, 2019 | icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed Sy... | There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate | Class I | ICU Medical, Inc. |
| 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 19, 2018 | ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800 | Inability or difficulty in unbuckling/releasing the proning arm buckle might delay patient access... | Class II | Arjohuntleigh Magog |
| Dec 19, 2018 | Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, ... | There is a potential for difficulty in sliding down the retention mechanism on the sets manufactu... | Class II | Cook Inc. |
| Dec 19, 2018 | Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, ... | There is a potential for difficulty in sliding down the retention mechanism on the sets manufactu... | Class II | Cook Inc. |
| Dec 7, 2018 | LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (... | The reaming guide and the guide rod can't be screwed into the intended depth. The reason for this... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Dec 6, 2018 | VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE)... | VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may ex... | Class II | Carl Zeiss Meditec, Inc. |
| Nov 27, 2018 | ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp... | Reports of pressure tubing separation between the sampling port and the high pressure tubing on c... | Class II | ICU Medical, Inc. |
| Nov 27, 2018 | ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp... | Reports of pressure tubing separation between the sampling port and the high pressure tubing on c... | Class II | ICU Medical, Inc. |
| Nov 27, 2018 | ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp... | Reports of pressure tubing separation between the sampling port and the high pressure tubing on c... | Class II | ICU Medical, Inc. |
| Nov 20, 2018 | Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product... | One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking... | Class II | Zimmer Biomet, Inc. |
| Nov 20, 2018 | Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Produ... | One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking... | Class II | Zimmer Biomet, Inc. |
| Nov 19, 2018 | Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600... | HVAD Battery Charger units manufactured with wrong inductors. | Class II | Heartware, Inc. |
| Nov 8, 2018 | SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 I... | There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow... | Class II | ICU Medical Inc |
| Nov 1, 2018 | The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardiov... | Experienced accelerated battery depletion and a shortened replacement interval due to latent inte... | Class II | Boston Scientific Corporation |
| Oct 31, 2018 | Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product C... | This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dua... | Class II | COVIDIEN LLC |
| Oct 31, 2018 | Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.0... | Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller ... | Class II | Zimmer GmbH |
| Oct 15, 2018 | Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, ... | There is a potential for the male connectors on external cables to become damaged. This could inc... | Class II | Jarvik Heart Inc |
| Oct 10, 2018 | Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage:... | Automated external defibrillators may not fully meet IPx5 water ingress specification. The device... | Class II | Philips Electronics North America Corp. |
| Oct 5, 2018 | Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 u... | Potential for leakage due to defect in the thermoset check valve component. | Class II | ICU Medical, Inc. |
| Oct 5, 2018 | Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per... | Potential for leakage due to defect in the thermoset check valve component. | Class II | ICU Medical, Inc. |
| Oct 5, 2018 | Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant in... | GE Healthcare has become aware of a potential safety issue that can occur if the canopy seals are... | Class II | Ohmeda Medical |
| Oct 5, 2018 | Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 u... | Potential for leakage due to defect in the thermoset check valve component. | Class II | ICU Medical, Inc. |
| Sep 25, 2018 | PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, S... | Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with s... | Class II | Pro-Dex Inc |
| Sep 18, 2018 | Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatri... | Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) fu... | Class I | COVIDIEN LLC |
| Sep 12, 2018 | Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Pro... | The firm received complaints related to the locking mechanism on the steerable inserter not funct... | Class II | Howmedica Osteonics Corp. |
| Sep 12, 2018 | 3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 ... | The product inside the package does not match the label. The product was labeled as long thread ... | Class II | Synthes (USA) Products LLC |
| Sep 7, 2018 | Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administr... | Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer... | Class II | Bayer Medical Care, Inc. |
| Aug 29, 2018 | INSORB SUBCUTICULAR SKIN STAPLER, REF 2030 | Possible compromise of the sterile barrier integrity | Class II | Incisive Surgical Inc |
| Aug 28, 2018 | Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. P... | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet... | Class II | Stryker GmbH |
| Aug 28, 2018 | Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 14... | Certain HVAD System Controller units may not meet the labeled standard for protection against wat... | Class II | Heartware, Inc. |
| Aug 28, 2018 | Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. ... | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet... | Class II | Stryker GmbH |
| Aug 28, 2018 | Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. ... | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet... | Class II | Stryker GmbH |
| Aug 28, 2018 | Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. ... | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet... | Class II | Stryker GmbH |
| Aug 20, 2018 | ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF... | Design change implemented changing the device from a blood set with a filter to a transfer set wi... | Class II | ICU Medical, Inc. |
| Aug 1, 2018 | Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model ... | A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a ... | Class II | ICU Medical Inc |
| Aug 1, 2018 | Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, ... | Potential for product sterility breach due to a compromised or pinched seal defect | Class II | COVIDIEN LLC |
| Aug 1, 2018 | Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441... | Potential for product sterility breach due to a compromised or pinched seal defect | Class II | COVIDIEN LLC |
| Aug 1, 2018 | Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.... | Potential for product sterility breach due to a compromised or pinched seal defect | Class II | COVIDIEN LLC |
| Aug 1, 2018 | Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 ... | Potential for product sterility breach due to a compromised or pinched seal defect | Class II | COVIDIEN LLC |
| Aug 1, 2018 | Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), ... | Potential for product sterility breach due to a compromised or pinched seal defect | Class II | COVIDIEN LLC |
| Jul 31, 2018 | Capnostream20 M NICU (CPM), CS08654RN | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 31, 2018 | Capnostream20 M ADULT ICU (CPM), CS08654RA | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac... | Class II | Oridion Medical 1987 Ltd. |
| Jul 17, 2018 | Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The... | There is a potential to generate incorrect results on the instrument if particular error codes ar... | Class II | Abbott Laboratories, Inc |
| Jul 17, 2018 | Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: Th... | There is a potential to generate incorrect results on the instrument if particular error codes ar... | Class II | Abbott Laboratories, Inc |
| Jul 17, 2018 | Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The... | There is a potential to generate incorrect results on the instrument if particular error codes ar... | Class II | Abbott Laboratories, 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.