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.

Clear
DateProductReasonClassFirm
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.