Hazard

Sterility Loss recalls

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

What the numbers show

Total: 46
Critical: 0
Severe: 10
Most recent: 2026-07-01

Of the 46 sterility loss 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 (22%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility loss 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.

26–46 of 46

HighFDA (Devices)·Z-2247-2021·2021-08-18
Jamshidi Bone Marrow Biopsy Needles Recalled for Packaging Seal Defects
Bard Peripheral Vascular Inc. is recalling multiple models of Jamshidi bone marrow biopsy needles due to incomplete or open packaging seals that may compromise sterility. No illnesses or injuries have been reported.
Product
TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm; TJM4011 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 11G x 10cm
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1286-2020·2020-02-26
Recall of Polysorb Sutures Due to Potential Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could impact sterility.
Product
Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1290-2020·2020-02-26
Polysorb Braided Absorbable Suture Recalled for Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.
Product
Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1275-2020·2020-02-26
Polysorb Suture Recall Due to Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact sterility.
Product
Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1279-2020·2020-02-26
Recall of Polysorb Braided Absorbable Suture Due to Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture 13-0 due to potential packaging integrity issues that may impact sterility.
Product
Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1282-2020·2020-02-26
FDA Recalls Polysorb Sutures Due to Packaging Integrity Issues
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may compromise sterility.
Product
Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1309-2020·2020-02-26
Nobel Biocare Recalls Tapered Dental Drills Due to Sterility Concerns
Nobel Biocare is recalling 260 units of tapered dental drills because a packaging sealing issue may compromise sterility during shelf life.
Product
Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1313-2020·2020-02-26
Nobel Biocare Dental Drills Recalled Due to Sterility Concerns
Nobel Biocare is recalling specific dental drills because a packaging defect may compromise their sterility during shelf life.
Product
Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0643-2019·2018-12-26
Theragenics Brachytherapy Applicator Needles Recalled for Unsealed Pouches
Theragenics is recalling Brachytherapy Applicator Needles because some pouches were not sealed, potentially compromising sterility.
Product
Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1635-2018·2018-05-16
Vygon U.S.A. Recalls Maximum Barrier Tray Due to Sterility Risk
Vygon U.S.A. is recalling the Maximum Barrier Tray (Product Code AMS-9018CP) because potential friction holes may compromise product sterility.
Product
Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0903-2018·2018-03-14
Synthes Reaming Rods Recalled for Potential Sterility Seal Defects
Synthes (USA) Products LLC is recalling 1,144 sterile 2.5 mm Reaming Rods due to potential gaps in the package seal that may compromise sterility.
Product
2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0905-2018·2018-03-14
Synthes 2.5 mm Guide Rods Recalled for Potential Sterility Loss
Synthes (USA) Products LLC is recalling 21 sterile 2.5 mm Guide Rods due to potential package seal defects that may compromise sterility.
Product
2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0043-2018·2017-11-01
MicroPort Orthopedics Recalls 48 Schanz Screws Due to Seal Defect
MicroPort Orthopedics is recalling 48 sterile Schanz screws due to an inadequate pouch seal that could compromise sterility and lead to infection.
Product
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0286-2016·2015-11-25
Civco Infiniti Plus Needle Guide Recalled Due to Sterility Concerns
Civco Medical Instruments is recalling 717 boxes of Infiniti Plus Needle Guides because the sterility of the product cannot be assured.
Product
CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0806-2015·2014-12-24
American Medical Systems Recalls AdVance Male Sling Systems Due to Packaging Defects
American Medical Systems is recalling AdVance Male Sling Systems because sterile barrier packaging may fail during extreme shipping and handling.
Product
AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commercially available in the US) The AdVance Male Sling System consists of two, sterile single-use surgical instruments called helical needle passers and a mesh sling with attache
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0281-2015·2014-12-03
Hospira Recalls Lactated Ringer's and 5% Dextrose Injection Bags
Hospira is recalling 275,448 bags of Lactated Ringer's and 5% Dextrose Injection due to potential punctures that may compromise sterility and cause leaks.
Product
Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7929-09.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1583-2014·2014-11-26
Medtronic Recalls Sterile O-Arm Drapes Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 sterile O-Arm drapes because returned devices were not adequately examined for damage to ensure sterility.
Product
DRAPE 9732722 TUBE STERILE O-ARM 20PK
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2550-2014·2014-09-03
Zimmer Recalls Trauma Tubes and Plates Due to Packaging Failures
Zimmer, Inc. is recalling specific trauma tubes and plates because packaging design verification tests failed, resulting in compromised seal integrity.
Product
Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TUBE & SCP PLT 90DX255LG TUBE & SCP PLT 95DX150LG TUBE & SCP PLT 95DX205LG TUBE & SCP PLT 95DX255LG TUBE&SCP PLT 130DX8H TUBE&SCP PLT 130DX10H TUBE&SCP PLT 130DX12H TUBE&SCP PLT 130DX14H TUBE&SC
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-442-2014·2014-01-22
Proparacaine HCl Ophthalmic Solution Recalled for Sterility Concerns
Specialty Medicine Compounding Pharmacy is recalling Proparacaine HCl ophthalmic solution because sterility cannot be assured due to shared compounding practices with a non-sterile product.
Product
Proparacaine HCl PF, 0.5% ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Category
Drug
Distribution
1 state
ModerateFDA (Devices)·Z-0879-2013·2013-03-06
Baylis Medical Recalls Unsealed Sterile RF Cannulas for Pain Relief
Baylis Medical is recalling 1,780 sterile RF cannulas distributed to Australia because some pouches were not sealed, risking sterility loss.
Product
BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined num
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-1665-2012·2012-09-05
Bracco Recalls Multihance Injection Due to Sterility Concerns
Bracco Diagnostics is recalling 4,870 vials of Multihance injection because aluminum crimp caps may displace during use, compromising sterility.
Product
MULTIHANCE — MULTIHANCE (GADOBENATE DIMEGLUMINE)
Category
Drug
Distribution
Distributed nationwide