Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 22, 2023 | HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, st... | Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing fo... | Class II | Howmedica Osteonics Corp. |
| Dec 22, 2023 | ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03... | Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that ... | Class II | Onkos Surgical, Inc. |
| Dec 22, 2023 | HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, steri... | Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing fo... | Class II | Howmedica Osteonics Corp. |
| Dec 22, 2023 | AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (... | Filling process qualification did not demonstrate adequate process capability. Possible consequen... | Class II | Musculoskeletal Transplant Foundation, Inc. |
| Dec 21, 2023 | MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 21, 2023 | FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, t... | Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to pati... | Class II | G & H Wire Company |
| Dec 21, 2023 | MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 21, 2023 | Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R | Medical devices distributed, prior to sterilization | Class II | Paragon 28, Inc. |
| Dec 21, 2023 | Article No. NA6050411, Valiant PhD No. 1 Econo | Affected product may not perform as expected; the amalgam powder may not triturate correctly and ... | Class II | Ivoclar Vivadent, Inc. |
| Dec 21, 2023 | CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510 | The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience ... | Class II | Cardinal Health 200, LLC |
| Dec 21, 2023 | Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 8... | Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The e... | Class II | Covidien LP |
| Dec 21, 2023 | PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code ... | Level 3 masks were produced on alternate non-validated production equipment that were not include... | Class II | AMD Medicom Inc. |
| Dec 21, 2023 | MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723 | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 21, 2023 | MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 21, 2023 | Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla... | Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious det... | Class II | Medagent Inc |
| Dec 21, 2023 | MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 21, 2023 | HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448) | Level 3 masks were produced on alternate non-validated production equipment that were not include... | Class II | AMD Medicom Inc. |
| Dec 21, 2023 | Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Caniste... | The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience ... | Class II | Cardinal Health 200, LLC |
| Dec 21, 2023 | Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Caniste... | The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience ... | Class II | Cardinal Health 200, LLC |
| Dec 21, 2023 | Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L | Medical devices distributed, prior to sterilization | Class II | Paragon 28, Inc. |
| Dec 21, 2023 | MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194A | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 21, 2023 | Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 ... | Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The e... | Class II | Covidien LP |
| Dec 21, 2023 | HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570... | Level 3 masks were produced on alternate non-validated production equipment that were not include... | Class II | AMD Medicom Inc. |
| Dec 21, 2023 | Phantom TTC Nail, 10.0 X 200mm, Right | Medical devices distributed, prior to sterilization | Class II | Paragon 28, Inc. |
| Dec 21, 2023 | TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600 | Due to, during the manufacturing process, the prescribed manufacturing and quality processes were... | Class II | MICROVENTION INC. |
| Dec 21, 2023 | MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 20, 2023 | Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Suction Connector with ENFit, REF EN0066000 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ ... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, ... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), ... | The firm has become aware of a sudden increase in complaints for three associated lots. Performan... | Class II | CooperSurgical, Inc. |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ ... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Barco MDSC-8527 NXF, Part Number K9352421 | Barco became aware of a problem with I2C cables in the manufacturing process of a limited batch o... | Class II | Barco N.V. |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | These wipes are saturated with 0.65% bleach solution. These wipes are antimic... | There is stability concern for products dated with a 24-month shelf life. Product is safe and eff... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 20, 2023 | Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenou... | When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5... | Class II | Zyno Medical LLC |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Lopez Valve¿ with ENFit, REF EN0056000 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, ... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12F... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 19, 2023 | Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-01... | Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part... | Class II | Smiths Medical ASD Inc. |
| Dec 19, 2023 | Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following R... | Distribution without Pre-Market Clearance | Class II | Acumed LLC |
| Dec 19, 2023 | REV 2 Flowcell Capsule Spare, Part Number: C04154 | Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear... | Class II | Beckman Coulter, 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.