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Search or scan any product against every CPSC, FDA, USDA, and NHTSA recall on record — or read the last 90 days below.
- 2026-07-22FDA-DeviceMedline Industries, LPClass IIMedline Total Knee Pack kits recalled for seal defects
Medline surgical kits containing Zimmer Biomet mixing bowls and spatulas have a seal defect that could compromise sterility. This defect could require surgeons to find an alternative device during a procedure. No injuries have been reported.
- 2026-07-22FDA-DevicePapablic IncClass IIPapablic replacement brush heads recalled for breakage risk
Papablic Replacement Brush Heads (Model PAPA317AA) may break during use. The recall affects specific lot numbers: PS2509A01, PS2511A01, and PS2512A01. No injuries have been reported.
- 2026-07-22FDA-DevicePapablic IncClass IIPapablic Replacement Brush Heads recalled for breakage risk
Papablic Replacement Brush Heads (Model Papablic18B) with specific lot numbers may break during use. The recall affects about 14,700 packs sold nationwide with lot numbers PS2509A01, PS2511A01, or PS2512A01 (date codes 2509, 2511, 2512).
- 2026-07-22FDA-DeviceOrthofix U.S. LLCClass IIOrthofix MINIRAIL fixation devices recalled for incorrect labeling
Orthofix external fixation devices used in orthopedic and trauma surgery have been shipped with incorrect labels. Some M101 models were labeled as M103, M103 models as M101, and M122 models as M111. This labeling error could lead to selection of the wrong device size during surgical procedures.
- 2026-07-22FDA-DeviceOrthofix U.S. LLCClass IIOrthofix Minirail Fixator devices recalled for incorrect labeling
Some Orthofix Articulated Minirail Fixator external fixation devices have been shipped with incorrect labels. Specifically, M101 units were labeled as M103, M103 units were labeled as M101, and M122 units were labeled as M111. Using the wrong component could affect the stability and effectiveness of orthopedic fixation.
- 2026-07-22FDA-DeviceOrthofix U.S. LLCClass IIOrthofix Minirail external fixation devices recalled for incorrect labeling
Orthofix Minirail orthopedic external fixation devices were shipped with incorrect model labels. Some M101 devices were labeled as M103, M103 devices were labeled as M101, and M122 devices were labeled as M111. This labeling error could cause confusion during surgical planning and device selection.
- 2026-07-22FDA-DeviceGE Medical Systems, LLCClass IIGE Optima XR radiography systems recalled for arm drop risk
GE HealthCare identified that some Optima XR200/220/240amx systems that underwent column replacement may not have had proper safety testing completed. If an internal cable fails, the safety mechanism could malfunction, allowing the X-ray arm to drop unexpectedly during patient exams.
- 2026-07-22FDA-DeviceBoston Scientific CorporationClass IIBoston Scientific injection system recalled for syringe disconnection risk
Boston Scientific's Rapid Refill Continuous Injection System contains a recalled syringe component that may loosen or disconnect from the device manifold. This could result in fluid leakage, inability to inject or aspirate properly, or complete separation of the syringe, potentially requiring device replacement and extending the procedure.
- 2026-07-22FDA-DeviceICU Medical, Inc.Class IIICU Medical Plum Solo IV pump recalled for overdose risk
In certain conditions, the Plum Solo Precision IV pump (v1.0.3) may not properly track the volume of fluid being delivered and could administer up to twice the intended amount of medication or fluid. This affects specific serial numbers of the pump.
- 2026-07-22FDA-DeviceICU Medical, Inc.Class IIICU Medical Plum Duo infusion pump recalled for overdose risk
Certain ICU Medical Plum Duo infusion pumps may fail to track the amount of fluid delivered on the screen display. In rare cases, this could cause the pump to deliver up to twice the intended volume of medication or fluid. This affects specific serial numbers of two item numbers (400020401 and 400020403) running software version 1.2.3.
- 2026-07-22FDA-DeviceIntuitive Surgical, Inc.Class IIIntuitive Surgical da Vinci drape recalled for detachment risk
Arm drapes used with Intuitive Surgical's da Vinci SP robotic surgical system may detach from the instrument arm due to a defect in the drape rings at the top of the product. If a drape detaches during surgery, it can expose part of the instrument arm and may delay the procedure or require switching to an alternative surgical approach.
- 2026-07-22FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus Ellik Evacuator glass body recalled for sterilization issue
Olympus has recalled the Glass Body for the 194 Ellik Evacuator (Model 190A) because some sterilization instructions in the user manual may not reliably make the device sterile. The affected sterilization parameters should no longer be used.
- 2026-07-22FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus Ellik Evacuator recalled for sterilization risk
Olympus has recalled the Ellik Evacuator (Model 194), a medical device used during urological procedures. Some sterilization methods described in the device instructions may not reliably sterilize the device, creating a potential infection risk.
- 2026-07-22FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus Toomey Evacuator 50cc recalled for sterilization risk
Olympus has recalled the Toomey Evacuator 50cc with Adaptor (Model 188A) because some sterilization instructions in the product manual may not reliably make the device fully sterile. Affected units were distributed worldwide, including across the US, Canada, Japan, Europe, and Latin America.
- 2026-07-22FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus Toomey Evacuator recalled for sterilization risk
Olympus has recalled the Toomey Evacuator 30cc with Adaptor (Model 188) because some of the sterilization instructions in the device manual may not reliably make the device sterile. The affected instructions should no longer be used.
- 2026-07-22FDA-DeviceArgon Medical Devices, IncClass IArgon Medical bone marrow tray recalled for sterility failure
Argon Medical Devices is recalling bone marrow tray kits (models CB0033TL and CB0355TLA) that contain lidocaine injections. The lidocaine ampules in these kits did not meet sterility standards required for safe use. The kits were distributed nationwide and internationally.
- 2026-07-22FDA-DeviceArgon Medical Devices, IncClass IArgon Medical Arterial Line Kit recalled for sterility failure
Argon Medical Devices is recalling certain Arterial Line Kits (model 20ga x 6, REF: 400115A) that contain Lidocaine HCL Injection. These kits failed sterility testing and do not meet safety release criteria. The affected kits have specific lot numbers with expiration dates in July 2027.
- 2026-07-22FDA-DeviceArgon Medical Devices, IncClass IArgon Medical T-Lok Bone Marrow Tray recalled for sterility failure
Argon Medical Devices is recalling T-Lok Bone Marrow Tray kits that contain Lidocaine HCL Injection ampules. These kits failed to meet sterility standards during quality testing. The affected kits were distributed nationwide and internationally.
- 2026-07-22FDA-DeviceArgon Medical Devices, IncClass IArgon Medical biopsy kit recalled for sterility failure
Argon Medical Devices is recalling General Biopsy Trays (REF: GUTS1000) that contain Lidocaine HCL Injection ampules. The lidocaine ampules in these kits did not meet sterility release criteria, meaning they may not be safe for use. Approximately 1,800 kits were distributed nationwide and to Trinidad and Tobago.
- 2026-07-22FDA-DeviceArgon Medical Devices, IncClass IArgon Medical introducer trays recalled for sterility issue
Argon Medical Devices is recalling One-Piece Introducer Trays (REF 497455 and 497434) that contain Lidocaine HCL Injection ampules. The Lidocaine ampules in these kits did not meet sterility release criteria, meaning they were not verified as free from contamination before distribution.
- 2026-07-22FDA-DeviceArgon Medical Devices, IncClass IArgon Medical pacing electrode trays recalled for sterility risk
Argon Medical Devices is recalling certain transvenous pacing electrode trays (model 008416A and 008566A) because they contain lidocaine ampules that did not meet sterility standards. The affected kits were distributed nationwide and internationally. No injuries have been reported.
- 2026-07-22FDA-DeviceAbiomed, Inc.Class IAbiomed Intro Kit introducer recalled for leakage risk
Abiomed heart pump introducer sheaths in the Intro Kit may leak fluid from under the sheath cap or along the hub score lines. The manufacturing defect is not visible to users. All current batches of the kit worldwide are affected.
- 2026-07-22FDA-DeviceAbiomed, Inc.Class IAbiomed Impella CP heart pump recalled for leakage risk
Abiomed has recalled the Impella CP heart pump due to a potential for fluid leakage from the introducer sheath (a tube inserted during the procedure). The leakage can occur under the sheath cap or along connection points, and these defects cannot be seen by the user. All current batches of the pump set are affected worldwide.
- 2026-07-22FDA-DeviceAbiomed, Inc.Class IAbiomed Impella CP heart pump recalled for sheath leakage risk
Abiomed has recalled its Impella CP Smart Assist Set heart pump due to a potential leak in the introducer sheath (a thin tube used during insertion). The leak can occur under the sheath cap or along seam lines in certain models, but the defect is not visible to the user. All current batches worldwide are affected.
- 2026-07-22FDA-DeviceAbiomed, Inc.Class IAbiomed Impella CP heart pump recalled for sheath leakage risk
Abiomed has recalled the Impella CP heart pump set due to a manufacturing defect in the introducer sheath that can cause leakage. The leakage can occur under the sheath cap or along hub score lines in the 14Fr and 23Fr introducers included with every pump set, and the defect is not visible to users.
- 2026-07-22FDA-DeviceAbiomed, Inc.Class IAbiomed Impella 5.5 heart pump recalled for sheath leakage risk
Abiomed has recalled certain Impella 5.5 SmartAssist S2 heart pump sets worldwide due to a manufacturing defect in the introducer sheaths. The 14Fr and 23Fr introducers included in these pump sets may leak fluid from under the sheath cap or along hub seams, and the leakage cannot be seen by the user before or during use.
- 2026-07-22FDA-DeviceAbiomed, Inc.Class IAbiomed Impella 5.5 heart pump recalled for leakage risk
The Abiomed Impella 5.5 Smart Assist Set heart pump contains an introducer sheath that may leak under the cap or along hub seams. This manufacturing defect is not visible to the user but is present in all affected pump sets. The issue affects 383 units distributed worldwide.
- 2026-07-22FDA-DeviceAbiomed, Inc.Class IAbiomed Introducer Kit recalled for sheath leakage risk
Abiomed has recalled certain Introducer Kit 23 Fr units (Pump Set Code 1000441) due to a potential for sheath leakage from under the sheath cap and along hub score lines. This manufacturing issue cannot be seen by the user and affects introducers included in every pump set.
- 2026-07-22FDA-DeviceAbiomed, Inc.Class IAbiomed Impella CP Introducer Kit recalled for leakage risk
Abiomed has recalled the Impella CP Introducer Kit (Pump Set Code 1000550) worldwide due to a potential for fluid leakage from under the sheath cap and along hub score lines in the 14Fr and 23Fr introducers. The leakage defect is not visible to the user and affects all current batches of this heart pump accessory kit.
- 2026-07-22FDA-DeviceAbiomed, Inc.Class IAbiomed Impella CP introducer recalled for leakage risk
Abiomed has recalled the Impella CP heart pump introducer due to a manufacturing defect that can cause fluid leakage from under the sheath cap and along the hub. The defect is not visible to the user and affects all current batches worldwide.