Hazard

Sterile Barrier Breach recalls

255 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 255
Critical: 0
Severe: 10
Most recent: 2026-08-12

Of the 255 sterile barrier breach recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (4%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterile barrier breach recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 255

SevereFDA (Devices)·Z-2840-2026·2026-08-12
Radial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
Boston Scientific is recalling Radial Jaw 4 Jumbo Biopsy Forceps due to potential breach in the sterile barrier of device packaging. The recall affects 5,020 units in the US and 20,770 units outside the US.
Product
Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2839-2026·2026-08-12
Biopsy Forceps Recall: Sterile Packaging Breach Risk
Boston Scientific is recalling Radial Jaw 4 Large Capacity Biopsy Forceps due to a potential breach in the sterile barrier of device packaging, which could compromise sterility.
Product
Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240cm Box 40; Outer Box UPN: M00513322; Inner Box UPN: M00513320. 3. Radial J
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2838-2026·2026-08-12
Boston Scientific Radial Jaw 4 Biopsy Forceps Recalled Due to Sterile Barrier Breach Risk
Boston Scientific Corporation is recalling specific Radial Jaw 4 Standard Capacity Biopsy Forceps because there is a potential for a breach in the sterile barrier of the device packaging.
Product
Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC 240cm Box 40; Outer Box UPN: M00513402; Inner Box UPN: M00513400. 3. Radia
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2758-2026·2026-07-29
Phantom Hindfoot Guide Rods Recalled Due to Sterile Barrier Breaches
Paragon 28 is recalling specific Phantom Hindfoot TTC/TC Ball Tipped Guide Rods because of complaints regarding breaches in the sterile pouch packaging.
Product
P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2218-2026·2026-05-27
Medtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
Medtronic is recalling certain lots of its DLP Retrograde Cannula (Model 94725), a cardiopulmonary bypass catheter, because the sterile barrier may be breached, potentially allowing contamination. The cannulas were distributed worldwide.
Product
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2216-2026·2026-05-27
Medtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
Medtronic Perfusion Systems is recalling certain lots of the DLP Retrograde Cannula (Model 94215T) due to a potential sterile barrier breach. The affected product is a cardiopulmonary bypass vascular catheter distributed worldwide.
Product
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2220-2026·2026-05-27
Medtronic DLP Retrograde Cannula 13FR Model 94913L Recall
Medtronic is recalling certain lots of DLP Retrograde Cannula (Model 94913L), a cardiopulmonary bypass catheter, due to potential sterile barrier breaches. The affected device was distributed worldwide.
Product
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2217-2026·2026-05-27
Medtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
Medtronic Perfusion Systems is recalling certain lots of the DLP Retrograde Cannula Model 94665 due to potential sterile barrier breach. The product is used in cardiopulmonary bypass procedures worldwide.
Product
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2214-2026·2026-05-27
Medtronic GUNDRY Retrograde Cannula Model 94113T sterile barrier recall
Medtronic is recalling certain lots of GUNDRY Retrograde Cannula (Model 94113T), a cardiopulmonary bypass catheter, due to potential sterile barrier breach in the product.
Product
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2221-2026·2026-05-27
Medtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
Medtronic is recalling certain lots of its DLP Retrograde Cannula (Model 94915), a cardiopulmonary bypass vascular catheter, due to potential sterile barrier breach.
Product
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2219-2026·2026-05-27
Medtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
Medtronic Perfusion Systems is recalling certain lots of the DLP Retrograde Cannula (Model 94913), a cardiopulmonary bypass vascular catheter, due to a potential sterile barrier breach.
Product
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2215-2026·2026-05-27
Medtronic GUNDRY Retrograde Cannula vascular catheter sterile barrier breach
Medtronic is recalling certain lots of GUNDRY Retrograde Cannula (Model 94115T) cardiopulmonary bypass vascular catheters due to potential sterile barrier breach. The affected product has been distributed worldwide.
Product
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2222-2026·2026-05-27
Medtronic DLP Retrograde Cannula Model 94965 Sterile Barrier Breach
Medtronic Perfusion Systems is recalling certain lots of the DLP Retrograde Cannula (Model 94965) due to potential sterile barrier breach. The cannula is used in cardiopulmonary bypass procedures.
Product
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1365-2026·2026-02-25
Integra CVS Wound Dressing Recall Over Sterile Barrier Breach Risk
Integra LifeSciences is recalling 2,906 units of its Private Label CVS wound dressings (Model CVS405406) due to potential packaging failures that could compromise the sterile barrier.
Product
Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0227-2026·2025-10-29
Bipolar hip heads recalled downstream after femoral components failed transit testing
Theken Companies is recalling 409 iNSitu Bipolar Hip System head assemblies in a downstream recall after BioPro femoral components failed transit testing, risking sterile barrier issues.
Product
iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Asse
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0150-2026·2025-10-22
Bipolar femoral heads recalled over packaging that may compromise sterility
BioPro is recalling 147 bipolar heads over a potential packaging issue that could compromise the sterile barrier and risk infection if implanted.
Product
BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR HEAD 41MM 18134 BIPOLAR HEAD 42MM 18135 BIPOLAR HEAD 43MM 18136 BIPOLAR HEAD 44MM 18137 BIPOLAR HEAD 45MM 18138 BIPOLAR HEAD 46MM 18139 BI
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0148-2026·2025-10-22
Metal and ceramic femoral heads recalled over sterile barrier packaging defect
BioPro is recalling 147 cobalt chromium and ceramic femoral heads over a potential packaging issue that could compromise the sterile barrier and risk infection if implanted.
Product
BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD FEMORAL 28MM-3 19005 HEAD FEMORAL 28MM+0 19006 HEAD FEMORAL 28MM+3 19007 HEAD
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0135-2026·2025-10-22
Goniotomy instruments recalled over compromised sterile packaging integrity
Iantrek is recalling 198 C-Rex UNO Microinterventional Goniotomy Instruments over the potential for compromised integrity of the sterile packaging.
Product
C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Goniotomy Instrument is a sterile single use disposable manual surgical instrument used in ophthalmic procedures for ab interno goniotomy and inne
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0134-2026·2025-10-22
Cyclodialysis surgical instruments recalled over compromised sterile packaging integrity
Iantrek is recalling 1,262 CycloPen Microinterventional Cyclodialysis Systems over the potential for compromised integrity of the sterile packaging.
Product
Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis device is a manual surgical instrument used for the ab-interno construction or modification of a cyclodialysis, followed by delivery of
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0149-2026·2025-10-22
Uni-polar endo heads recalled over packaging that may compromise sterility
BioPro is recalling 147 metal uni-polar Endo Heads over a potential packaging issue that could compromise the sterile barrier and risk infection if implanted.
Product
BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181 ENDO MD 43 10182 ENDO MD 45 10183 ENDO MD 47 10184 ENDO MD 49 10185 ENDO MD 51 10186 ENDO MD 53 10187 ENDO MD 55 10188 ENDO SH 38 10189 ENDO SH 41 10190 E
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0151-2026·2025-10-22
Ceramic femoral heads recalled over packaging that may compromise sterile barrier
BioPro is recalling 147 ceramic femoral heads over a potential packaging issue that could compromise the sterile barrier and present a risk of infection if implanted.
Product
BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024 HEAD FEMORAL CERAMIC 28MM +0 19025 HEAD FEMORAL CERAMIC 32MM -3 19026 HEAD FEMORAL CERAMIC 32MM +0 19027 HEAD FEMORAL CERAMIC 32MM +3
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0153-2026·2025-10-22
Femoral head implants recalled over packaging that may compromise sterile barrier
BioPro is recalling 147 femoral head implants over a potential packaging issue that could compromise the sterile barrier and present a risk of infection if implanted.
Product
BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 HEAD FEMORAL 32 LG LT
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0152-2026·2025-10-22
Ceramic endo modular heads recalled over sterile barrier packaging defect
BioPro is recalling 147 ceramic Endo Modular Heads over a potential packaging issue that could compromise the sterile barrier and risk infection if implanted.
Product
BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 13007 ENDO MODULAR CERAMIC SH 41 13008 ENDO MODULAR CERAMIC SH 43 13009 ENDO MODULAR CER
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0020-2026·2025-10-08
Reprocessed 1.7mm over the wire atherectomy catheters recalled for sterility breaches
Northeast Scientific is recalling 165 reprocessed 1.7mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0022-2026·2025-10-08
Reprocessed 0.9mm rapid exchange atherectomy catheters recalled for sterile barrier breaches
Northeast Scientific is recalling 795 reprocessed 0.9mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.
Product
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is
Category
Medical Device
Distribution
Distributed nationwide