Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 12, 2022 | BASIN SET, MEBS42K, general surgical kit | Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the... | Class II | American Contract Systems, Inc. |
| Oct 12, 2022 | Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), ... | The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label ... | Class II | Medical Action Industries, Inc. 306 |
| Oct 4, 2022 | NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallo... | The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium ... | Class II | Fresenius Medical Care Holdings, Inc. |
| Oct 3, 2022 | BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of ... | Due to partial label detachment on tubes. This can cause tubes to become stuck together in the po... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Oct 3, 2022 | BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of ... | Due to partial label detachment on tubes. This can cause tubes to become stuck together in the po... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Oct 3, 2022 | BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), ... | Due to partial label detachment on tubes. This can cause tubes to become stuck together in the po... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Sep 28, 2022 | Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Informa... | Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notificatio... | Class II | iRhythm Technologies, Inc. |
| Sep 28, 2022 | Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104 | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304 | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115 | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600 | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204 | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 15, 2022 | B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (car... | The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10... | Class II | Medical Action Industries, Inc. 306 |
| Sep 14, 2022 | Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Lue... | Sterile extension sets were distributed without an expiration date | Class II | Avanos Medical, Inc. |
| Sep 14, 2022 | ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 ... | Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affe... | Class II | ARROW INTERNATIONAL Inc. |
| Sep 7, 2022 | Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308... | Product pouch label does not match up with carton label | Class II | BALT USA, LLC |
| Sep 2, 2022 | Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code C... | Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barc... | Class III | Baxter Healthcare Corporation |
| Sep 1, 2022 | Recreo Hair Growth Laser Comb | The firm distributed the laser products without affixing the warning, aperture, certification, an... | Class II | OMM Imports, Inc. dba Zero Gravity |
| Aug 19, 2022 | MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001 | Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible b... | Class III | Canadian Hospital Specialties |
| Aug 12, 2022 | COVID Test Kit Nonsterile | Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 dev... | Class II | American Contract Systems, Inc. |
| Aug 9, 2022 | The BioZorb LP Marker is an implantable radiopaque marker used to facilitate ... | Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels ... | Class II | Hologic, Inc |
| Aug 5, 2022 | LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. in... | The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal ... | Class II | Datascope Corporation |
| Aug 3, 2022 | stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright ... | The outer label does not match the device inside the package. The affected lot of EVOLVE Proline ... | Class II | Wright Medical Technology, Inc. |
| Aug 3, 2022 | MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 1... | Potential for the suction catheter to come apart from the green connector near the thumb valve. T... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 3, 2022 | stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wrigh... | The outer label does not match the device inside the package. The affected lot of EVOLVE Proline ... | Class II | Wright Medical Technology, Inc. |
| Aug 3, 2022 | MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch... | Potential for the suction catheter to come apart from the green connector near the thumb valve. T... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 3, 2022 | MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER, flat peel pouch EA, 1... | Potential for the suction catheter to come apart from the green connector near the thumb valve. T... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 1, 2022 | BD MaxGuard Extension Set, REF: ME1069 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Extension Set with 4-way stopcock, REF: M4058 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: ... | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: ... | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-por... | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Jul 29, 2022 | Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Freeman Pancreatic Flexi-Stent Catalog Number: 6566 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Posi-Stop Injection Needle Catalog Number: 4712 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Medical Polypectomy Snare Catalog Number: 4563 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Medical Flex-Ez Guide Wire Disposable For endoscopy procedures Ref:... | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Freeman Pancreatic Flexi-Stent Kits: Single Pigtail (containing 6544) Catal... | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Posi-Stop Injection Needle Catalog Number: 4720 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Biliary Pigtail Stent Kits Catalog Number: 6105 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Helical Retrieval Basket Catalog Number: 4814 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, Inc. |
| Jul 29, 2022 | Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024 | Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... | Class II | Hobbs Medical, 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.